Sleep Disorders clinical trials at University of California Health
55 in progress, 36 open to eligible people
A Randomized Controlled Trial of Doxazosin for Nightmares, Sleep Disturbance, and Non-Nightmare Clinical Symptoms in PTSD
open to eligible people ages 18-75
This randomized, double-blind, placebo-controlled trial of doxazosin will assess doxazosin's effectiveness for PTSD nightmares, subjective sleep quality, and non-nightmare PTSD symptoms in adult men and women veterans with full and partial-syndromal PTSD.
at UCSF
A Study of Seltorexant Compared to Quetiapine XR as Adjunctive Therapy to Antidepressants in Adult and Elderly Participants With Major Depressive Disorder With Insomnia Symptoms Who Have Responded Inadequately to Antidepressant Therapy
open to eligible people ages 18-74
The purpose of this study is to assess the efficacy of seltorexant compared with quetiapine extended-release (XR) as adjunctive therapy to an antidepressant drug in treatment response in participants with major depressive disorder with insomnia symptoms (MDDIS) who have had an inadequate response to current antidepressant therapy with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI).
at UCSD
Acetazolamide for Obstructive Sleep Apnea to Improve Heart Health
open to eligible people ages 18-50
Obstructive sleep apnea (OSA) is a severe type of snoring causing people to choke in their sleep. It affects millions of Americans, causing many health problems. For example, patients with OSA often feel very sleepy and are at risk of falling asleep while driving. OSA also causes elevated blood pressure increasing the risk for heart attacks and strokes. Patients with OSA are often treated with a face-mask that helps them breath at night but can be difficult to tolerate. In fact, about half the patients eventually stop using this mask. Because there are few other treatments (and no drug therapy), many OSA patients are still untreated. Of note, especially young adults (i.e. 18 to 50 years old) benefit from treating their OSA, but they are also less likely to use the mask. Acetazolamide (a mild diuretic drug) has been used for over 50 years to treat many different conditions and is well tolerated. Recent data suggest, that acetazolamide may help OSA patients to not choke in their sleep and lower their blood pressure. Especially young adults with OSA are likely to respond well to this drug. Further, its low cost (66¢/day) and once- daily dosing may be particularly attractive for young OSA patients unable or unwilling to wear a mask each night. But previous studies had many limitations and did not focus on young adults. The goal of this study is to test if acetazolamide can improve sleep apnea and cardiovascular health in young adults with OSA (18-50 years old), and how it does that. Thus, we will treat 46 young OSA patients with acetazolamide or placebo for 2 weeks each. The order in which participants receive the drug or placebo will be randomized. At the end of each 2 week period we will assess OSA severity and cardiovascular health. Thus, this study will help assess acetazolamide's potential value for OSA treatment, and may also help to identify patients who are most likely to respond to acetazolamide (including select individuals >50 years of age). Ultimately, this work promises a drug therapy option for millions of OSA patients who are unable to tolerate current treatments.
at UCSD
Apnea and Insomnia Relief Study
open to eligible people ages 18 years and up
The purpose of this study is to determine whether a behavioral sleep treatment improves functioning and sleep in Veterans with posttraumatic stress disorder (PTSD).
at UCSF
Applying Best Clinical Practices to Patients at High Risk of Respiratory Complications
open to eligible people ages 18 years and up
The purpose of this study is to: 1. Perform a retrospective analysis on data contained in the UCLA Perioperative Data Warehouse on the incidence of respiratory dysfunction in the post-operative care unit (PACU) before and after the introduction of sugammadex into clinical practice. 2. Develop and implement a clinical best practice pathway designed to prevent postoperative respiratory complications in higher risk patients (such as those with OSA or preexisting respiratory disease) using education and clinical decision support in patients.
at UCLA
Brain Changes in Pediatric OSA
open to eligible people ages 7-12
Obstructive sleep apnea (OSA) is highly prevalent in children and is often caused by overgrowth of the child's adenoids and/or tonsils. Consequently, adenotonsillectomy (removal of the tonsils and adenoids) is the most common treatment of OSA in children, although just the tonsils or adenoids may be removed depending on the case. As well, OSA in children is often associated with cognitive dysfunction and mood issues, suggesting brain changes due to the condition. However, the link between brain changes, cognitive and moods issues, and OSA in children has not been thoroughly explored. Therefore, this study aims to examine brain changes, cognition and mood in pediatric OSA subjects compared to controls as well as before and after removal of the adenoids and/or tonsils. This study hopes to enroll 70 subjects, ages 7-12 years, 35 healthy controls and 35 subjects diagnosed with OSA and scheduled for an adenoidectomy and/or tonsillectomy. Control subjects will schedule one visit to UCLA and OSA subjects will schedule two. Upon the first visit, all subjects will undergo cognitive, mood and sleep questionnaires and MRI scanning. That will be the duration of the controls' participation in the study; however, OSA subjects will return 6 months later (after their adenoidectomy and/ or tonsillectomy) to repeat the same procedures. Sleep quality, mood, cognition and brain images will be compared between OSA and controls and between OSA subjects before surgery and after surgery.
at UCLA
Brief Behavioral Treatment for Insomnia in Veterans With Posttraumatic Stress Disorder
open to eligible people ages 18-75
This study will investigate treatments for insomnia in Veterans who have posttraumatic stress disorder (PTSD). The purpose of this study is to compare a brief behavioral treatment for insomnia (BBTI) to a treatment that helps promote relaxation (progressive muscle relaxation training or PMRT). The investigators will examine improvements in psychosocial functioning and insomnia severity. The investigators will also examine whether treatment gains last over time and whether suicidal ideation decreases following insomnia treatment.
at UCSF
Brief Versus Standard Cognitive Behavioral Therapy for Insomnia in Veterans
open to eligible people ages 18 years and up
Insomnia is a common condition in Veterans, with prevalence rates as high as 53% among treatment-seeking Veterans. Chronic untreated insomnia is associated with increased risk for functional impairment, psychiatric illness, suicidal ideation, unhealthy lifestyles, and decreased quality of life. Cognitive-Behavioral Therapy for Insomnia (CBT-I) is recognized as the first-line treatment for insomnia. Despite its proven efficacy, CBT-I is not always readily provided and/or accessible to Veterans. To address these limitations, behavioral sleep medicine specialists have endeavored to streamline CBT-I through development of time-shortened variations of CBT-I. Although these modifications show promise for advancing care and access, studies comparing brief treatments to standard CBT-I have yet to be performed. This investigation will therefore compare a 4-session brief CBT-I to VA standard 6-session CBT-I to evaluate whether a brief intervention can provide comparable benefits to sleep, functional, and psychiatric outcomes in Veterans with insomnia.
at UCSD
CBD for Sleep in People With HIV
open to eligible people ages 18 years and up
This study will obtain preliminary information about whether, and at what dose, cannabidiol (CBD) may help with insomnia in people living with human immunodeficiency virus (HIV). The study will be a 5-week randomized, double-blind placebo-controlled phase II trial using daily oral CBD doses between 50mg and 600mg. Sleep problems will be measured using a wrist-worn device and by self-report. Performance on tests of thinking skills will be compared before and after CBD/placebo treatment. Positive study results will provide support for the use of CBD as a potential treatment for insomnia.
at UCSD
Combination Drug-Therapy for Patients With Untreated Obstructive Sleep Apnea
open to eligible people ages 18-65
Obstructive sleep apnea (OSA) is common and associated with many adverse health consequences, but many patients are unable to tolerate standard therapies such as continuous positive airway pressure (CPAP) and thus remain untreated. Single-drug therapies have shown promising results in treating sleep apnea, but on average patients have only experienced partial relief. Multi-drug therapy may offer a more effective treatment approach. The goal of this study is to test the effect of combination therapy with three FDA-approved drugs (Diamox [acetazolamide], Lunesta [eszopiclone] +/- Effexor [venlafaxine]) on OSA severity and physiology.
at UCSD
Do Endotypes Predict Response and Sequelae in OSA Patients
open to eligible people ages 21-65
This study will investigate why some people have Obstructive Sleep Apnea (OSA) and how the underlying cause may relate to OSA manifestations (including sleepiness and high blood pressure) and response to different therapeutic approaches (ie CPAP, eszopiclone, and supplemental oxygen). Understanding why someone has OSA could affect how best to treat that individual, but may also have an impact on what problems the disease might cause.
at UCSD
Effect of Myofunctional Therapy on OSA
open to eligible people ages 18-70
The primary medical therapies for patients with Obstructive Sleep Apnea syndrome (OSA) require the use of medical devices on a nightly basis to help control breathing during sleep, which can be difficult for patients with mild-to-moderate disease. Because many patients use these therapies on a limited basis, or stop using them altogether, they continue to be at increased risk of the consequences of untreated OSA. Untreated and undertreated OSA compounds the risk of OSA consequences over time, particularly with increasing age and weight. Orofacial Myofunctional Therapy (OMT) takes a rehabilitative approach to OSA and is comprised of isotonic and isometric exercises that target the oral (e.g., tongue) and oropharyngeal (e.g., soft palate, lateral pharyngeal wall) to help restore normal breathing and airway patency at night while asleep. Should the study have positive findings, OMT could become an important alternative therapy for patients with mild-to-moderate disease because patients could utilize a therapy that improves their nighttime breathing through daytime exercises and without the need for a burdensome medical device.
at UCSD
Forehead Temperature-Regulating Therapy for Insomnia in Adults With Tourette's Disorder
open to eligible people ages 18-50
The primary aim of the present research project is to investigate the preliminary effects of four weeks of forehead temperature-regulating therapy on insomnia in adults with Tourette's disorder and co-occurring insomnia disorder. This project will also examine the effects of the device on depression, anxiety, and daytime sleepiness, and explore its effects on tic severity.
at UCLA
Insomnia Treatment and Cardiometabolic Health in Older Adults With Posttraumatic Stress Disorder
open to eligible people ages 55 years and up
This pilot randomized controlled trial will address a gap in knowledge related to addressing modifiable risk factors for cardiometabolic disease through treating residual insomnia, sleep difficulties that remain after successful treatment of another condition, in the context of PTSD in understudied older adults. This study provides a non-medication treatment for PTSD called Cognitive Processing Therapy (CPT) followed by one of two non-medication sleep education and treatment programs for sleep problems that remain after completing PTSD treatment in older adults with PTSD. The aims of this project are to evaluate 1) the added benefits of treating residual insomnia on sleep and PTSD symptoms; 2) the added benefits of treating residual insomnia following CPT on cardiometabolic risk biomarkers and quality of life; and 3) the durability of the sleep, PTSD, cardiometabolic and quality of life benefits of treating residual insomnia following CPT at 6-month follow-up in older adults with PTSD.
at UCLA
Is Obstructive Sleep Apnea Important in the Development of Alzheimer's Disease?
open to eligible people ages 65-85
Obstructive sleep apnea (OSA) is common in older adults and has recently been implicated in pathogenesis of Alzheimer's disease (AD). Research has shown that sleep disruptions have caused memory impairment. Sleep apnea is a form of sleep disruption. We would like to examine how obstructive sleep apnea may contribute to the progression of Alzheimer's disease.
at UCSD
Lemborexant in Delayed Sleep Phase Syndrome
open to eligible people ages 18 years and up
The purpose of the study is to evaluate whether Lemborexant is more effective than placebo in shortening sleep onset latency in patients with delayed sleep phase syndrome (both type 1 and type 2). This will be tracked using sleep logs as well as actigraphy. In this 2-year study, we will examine if Lemborexant administered 5-10 mg nightly taken at desired bedtime (at least 2 hours prior to self-reported sleep onset habitual time) can improve the symptoms of Delayed Sleep Phase Syndrome.
at UCSF
Lemborexant Shift Work Treatment Study
open to eligible people ages 20-60
Insomnia and daytime sleepiness are common complaints among night shift workers, but effective sleep treatments in shift workers are lacking. The aim of this Phase IV double-blind, placebo-controlled, randomized study is to test whether a dual orexin antagonist, Lemborexant (5mg or 10mg), which would be expected to block the clock-driven orexin-mediated wakefulness during the day, will increase daytime sleep time in shift workers who complain of difficulty sleeping during the daytime compared to placebo.
at UCSF
Magnetic Apnea Prevention(MAGNAP) Device to Treat Obstructive Sleep Apnea:First-In-Human Study of Feasibility and Safety
open to eligible people ages 21-70
The purpose of this study is to determine the safety and feasibility of the Magnap magnetic device in the treatment of obstructive sleep apnea (OSA).
at UCSF
National Adaptive Trial for PTSD Related Insomnia
open to eligible people ages 18-75
Many Veterans with posttraumatic stress disorder (PTSD) have trouble sleeping or have frequent nightmares. So far, no medication has been approved for treatment of insomnia in PTSD. The purpose of this research study is to find out if taking medications called trazodone, eszopiclone, or gabapentin can help decrease symptoms of insomnia in patients with PTSD. PTSD is a form of intense anxiety which sometimes results from severe trauma. Symptoms may include nightmares, flashbacks, troublesome memories, difficulty sleeping, poor concentration, irritability, anger, and emotional withdrawal. Insomnia is a disorder that can make it hard to fall sleep, stay asleep or cause a person to wake up too early and not be able to fall back to sleep.
at UCSD UCSF
OSA PAP Treatment for Veterans With SUD and PTSD on Residential Treatment Unit
open to eligible people ages 18 years and up
Substance use disorder (SUD) and posttraumatic stress disorder (PTSD) frequently co-occur and having both disorders is associated with greater psychological and functional impairment than having either disorder alone. This is especially true in residential settings where both disorders are more severe than outpatient settings. Obstructive sleep apnea (OSA) is highly comorbid with both disorders and untreated OSA is associated with worse functional impairment across multiple domains, worse quality of life, worse PTSD, higher suicidal ideation, and higher substance use and relapse rates. Treating OSA with evidence-based positive airway pressure (PAP) in Veterans with SUD/PTSD on a residential unit is a logical way to maximize treatment adherence and treatment outcomes. This study compares OSA treatment while on a SUD/PTSD residential unit to a waitlist control group. The investigators hypothesize that treating OSA on the residential unit, compared to the waitlist control, will have better functional, SUD, and PTSD outcomes.
at UCSD
Patient-centered and Neurocognitive Outcomes With Acetazolamide for Sleep Apnea
open to eligible people ages 18 years and up
Obstructive sleep apnea (OSA) is a severe type of snoring causing people to choke in their sleep. It affects millions of Americans, causing many health problems. For example, patients with OSA often feel very sleepy and are at risk of falling asleep while driving. OSA also causes elevated blood pressure, memory problems and can severely affect quality of life. Patients with OSA are often treated with a face-mask that helps them breath at night but can be difficult to tolerate. In fact, about half the patients eventually stop using this mask. Because there are few other treatments (and no drug therapy), many OSA patients are still untreated. Acetazolamide (a mild diuretic drug) has been used for over 50 years to treat many different conditions and is well tolerated. Recent data suggest, that acetazolamide may help OSA patients to not choke in their sleep and lower their blood pressure. Further, its low cost (66¢/day) and once-daily dosing may be attractive for OSA patients unable or unwilling to wear a mask each night. But previous studies had many limitations such as studying acetazolamide for only a few days and not capturing important outcomes. The goal of this study is to test if acetazolamide can improve sleep apnea, neurocognitive function and quality of life in adults with OSA, and to assess how it does that. Thus, the investigators will treat 60 OSA patients with acetazolamide or placebo for 4 weeks each. The order in which participants receive the drug or placebo will be randomized. At the end of each 4 week period the investigators will assess OSA severity, neurocognitive function and quality of life. Thus, this study will help assess acetazolamide's potential value for OSA treatment, and may also help to identify patients who are most likely to respond to acetazolamide. Ultimately, this work promises a drug therapy option for millions of OSA patients who are unable to tolerate current treatments
at UCSD
Perinatal Research on Improving Sleep and Mental Health
open to eligible females ages 18 years and up
The goal of this clinical trial is to compare two sleep programs in pregnant people with insomnia. The main questions it aims to answer are: 1. What is the efficacy of digital cognitive behavioral therapy for insomnia (CBT-I) versus digital sleep hygiene education (SHE) for preventing perinatal depression? 2. Is the effect of digital CBT-I on perinatal depression mediated through prenatal insomnia symptom improvement? 3. Is the effect of digital CBT-I on perinatal depression moderated by baseline depressive symptom severity? Participants will receive one of two sleep programs - SHE or CBT-I. Both involve six weekly online sessions. Participants will complete surveys and interviews until 1 year postpartum.
at UCSF
Pilot Test of Apnea and Insomnia Relief for Veterans With Gulf War Illness
open to eligible people ages 48-80
The purpose of this study is to determine whether a behavioral sleep treatment improves sleep and other Gulf War Illness (GWI) symptoms in Gulf War Veterans with GWI.
at UCSF
Prospective Randomized Trial of CPAP for SDB in Patients Who Use Opioids
open to eligible people ages 18 years and up
Patients with chronic pain who use opioids appear to be at increased risk for breathing issues during sleep, termed sleep disordered breathing (SDB). Treatment of SDB often consists of use of a device during sleep that provides continuous positive airway pressure (CPAP) via a mask interface. The goal of this study is to determine whether patients with chronic pain who use opioids and have SDB might benefit from the use of CPAP in terms of sleep quality, pain, quality of life, and other measures. In addition, the study will examine whether these individuals are able to adhere to CPAP, which will be important for future studies. Lastly, we anticipate that CPAP won't work for everyone due to the changes that opioids can cause in breathing patterns. We will examine how often CPAP is ineffective, and whether we can predict which individuals are least likely to resolve their SDB with CPAP.
at UCSD
Reaching for Equity in Sleep Apnea Treatment (REST) Study
open to eligible people ages 18 years and up
This study will test a brief telephonic health coaching intervention to improve adherence to positive airway pressure therapy for treatment of obstructive sleep apnea.
at UCSF
Restoring Metabolic and Reproductive Health With Sleep in PCOS Study, CPAP Trial
open to eligible females ages 18-40
In this study, the researchers are trying to learn more about the relationship between Polycystic Ovary Syndrome and Obstructive Sleep Apnea (OSA). Obstructive Sleep Apnea is a sleep-related breathing disorder that involves a decrease or complete stop in airflow. The purpose of this study is to find out why some people with obstructive sleep apnea have higher levels of insulin resistance, and the investigators will study the role of hypoxia (low levels of oxygen in the blood at night) in insulin resistance and see if insulin resistance improves during your treatment with CPAP.
at UCSF
Sleep and Healthy Aging Research for Depression (SHARE-D) Study
open to eligible people ages 60-80
Late-life depression is a significant public health concern, and effective interventions for prevention and treatment are needed. Insomnia and inflammation are modifiable targets for depression prevention, and this study is significant in using an experimental approach (i.e., inflammatory challenge) to probe acute inflammatory- and depression responses as a function of insomnia, which will inform identification of molecular targets for pharmacologic interventions, and improvement of insomnia treatments to prevent depression in older adults. Project
at UCLA
Sleep for Stroke Management and Recovery Trial
open to eligible people ages 18 years and up
The purpose of this study is to determine whether treatment of obstructive sleep apnea (OSA) with positive airway pressure starting shortly after acute ischemic stroke or high risk TIA (1) reduces recurrent stroke, acute coronary syndrome, and all-cause mortality 6 months after the event, and (2) improves stroke outcomes at 3 months in patients who experienced an ischemic stroke.
at UC Davis UC Irvine UCLA UCSD UCSF
Suvorexant: A Dual Orexin Receptor Antagonist for Treating Sleep Disturbance in Posttraumatic Stress
open to eligible people ages 18-75
Post-traumatic stress disorder (PTSD) is a common consequence of combat that can result in trauma-related hyperarousal and sleep disturbances. Poor sleep, one of the most common complaints in Veterans with PTSD, can be distressing, impair concentration and memory, and contribute to physical health conditions, such as metabolic syndrome, inflammation, and cardiovascular disease. The orexin neuropeptide system underlies both sleep and stress reactivity. Suvorexant, a drug that reduces orexin, improves sleep in civilians, but has not yet been tested in Veterans with PTSD. This study will test whether suvorexant can improve sleep disturbances and PTSD symptoms in Veterans. Suvorexant may benefit Veterans by improving sleep quickly while also reducing PTSD symptoms over the long term, and with fewer side effects that were common in previous medications used to treat these conditions. Improving Veterans' sleep and PTSD symptoms could lead to better emotional and physical well-being, quality of life, relationships, and functioning.
at UCSF
The Reducing Risk Study
open to eligible people ages 12-18
The present study will test an innovative mobile health adaptation of a behavioral intervention that improves sleep and mental health concerns among adolescents.
at UCSF
UCLA REST Study (REsearch on Sleep Techniques)
open to eligible people ages 18-20
Sleep disturbance has a range of negative effects on psychosocial and biological processes important for academic and social success as well as mental and physical health among adolescents and young adults. Limited, inconsistent, and poor quality sleep lead to anxiety, depressive feelings, loneliness, and fatigue over time. These symptoms, in turn, interfere with the ability to get a good night's rest. Sleep disruption can also upregulate inflammatory processes during the years of adolescence and young adulthood in ways that can create risk for the development of chronic health conditions (e.g., diabetes, depression, cardiovascular disease) in later adulthood. Sleep, however, is also a modifiable health behavior, leading many institutions to embark upon efforts to improve the sleep of their students. The challenge is to identify programs and interventions that can simultaneously improve sleep, be delivered at scale, and be easily completed by students. UCLA has developed and validated a group-based mindfulness intervention, Mindful Awareness Practices (MAPs), that has demonstrated beneficial effects on sleep in adults and may offer a promising, scalable approach for reducing sleep disturbance and improving associated psychological and biological outcomes in college students. However, this approach requires validation in this population relative to sleep education programs, which increasingly dominate the college landscape. To address this important public health problem, the investigators propose to conduct a single site, two-arm, parallel group randomized controlled trial to test the efficacy of the validated, group-based, six-week MAPs intervention vs. sleep education, an active time and attention matched control condition, for first year undergraduate students who report poor sleep at this critical transition year. The investigators are aiming to enroll approximately 240 participants. Participants will complete questionnaires, provide blood samples for immune analysis and will be provided with wrist actigraphs to wear for 7 days, in order to collect objective measurements of sleep at pre- and post-intervention visits, and at a 3-month follow-up visit. Additional follow-up assessments will take place at 6-month, and 12-month post-intervention to evaluate persistence of effects.
at UCLA
Direct Referral for Apnea Monitoring
open to eligible people ages 18 years and up
The primary objective of this project is to compare a health care delivery model, Direct Referral for Apnea Monitoring (DREAM), with initial in-person (Traditional) clinic appointments for Veterans at risk for obstructive sleep apnea (OSA). A secondary objective is to determine the negative predictive value (NPV) of home sleep apnea testing (HSAT).
at UCSF
Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)
open to eligible people ages 0-20
The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. The primary objective of this study is to evaluate the PK of understudied drugs currently being administered to children per SOC as prescribed by their treating provider.
at UCLA
Postoperative Neurocognitive Disorders
open to eligible people ages 40-75
The purpose of this study is to examine the mechanisms of brain injury contributing to postoperative neurocognitive disorders (PNCD) in an at-risk population (obstructive sleep apnea (OSA)) undergoing surgery. The investigators will enroll 50 OSA patients scheduled for surgery. All patients will have a brain scan (fMRI) within five days before surgery and two days and six months after surgery. During this visit cognitive function will be assessed using the Wide Range Assessment of Memory and Learning (WRAML2) and Montreal Cognitive Assessment (MoCA) tests. Patients will also be asked to participate in a blood draw during the first 2 visits for fMRI (within five days of surgery and two days after surgery). The Confusion Assessment Method (CAM-S) test, will be used to examine postoperative delirium.
at UCLA
remedē System Therapy Study
open to eligible people ages 18 years and up
The purpose of this non-randomized post market study is to collect clinical data on the safety and effectiveness of the remedē System in a real-world setting.
at UCSF
Tissue-specific Insulin Resistance in Obstructive Sleep Apnea: Role of Hypoxia
open to eligible people ages 19-100
Obstructive sleep apnea (OSA) is a common condition associated with significant adverse health outcomes. Our overarching hypothesis is that patients with OSA and hypoxia (H-OSA) have greater degrees of insulin resistance in both liver and adipose tissue when compared to those without hypoxia (NH-OSA) thus leading to increased risk for the development of diabetes in the former group.
at UCSF
A Dose Selection Study of Light Therapy for Impaired Sleep in Parkinson’s Disease
Sorry, in progress, not accepting new patients
This study aims to determine the most effective dose of light therapy to improve sleep in people with Parkinson's Disease. Four groups of participants will receive bright-white or dim-red light therapy at different times throughout the day.
at UC Davis UC Irvine
A Study of Danavorexton in People With Obstructive Sleep Apnea After General Anesthesia for Abdominal Surgery
Sorry, not currently recruiting here
The main aim is to see if danavorexton can help improve people's breathing in the recovery room after abdominal surgery.
at UCSD
Advancing Understanding of Transportation Options
Sorry, in progress, not accepting new patients
This Stage II randomized, controlled, longitudinal trial seeks to assess the acceptability, feasibility, and effects of a driving decision aid use among geriatric patients and providers. This multi-site trial will (1) test the driving decision aid (DDA) in improving decision making and quality (knowledge, decision conflict, values concordance and behavior intent); and (2) determine its effects on specific subpopulations of older drivers (stratified for cognitive function, decisional capacity, and attitudinally readiness for a mobility transition). The overarching hypotheses are that the DDA will help older adults make high-quality decisions, which will mitigate the negative psychosocial impacts of driving reduction, and that optimal DDA use will target certain populations and settings.
at UCSD
CBT-I or Zolpidem/Trazodone for Insomnia
Sorry, in progress, not accepting new patients
This study is a randomized (1:1:1) comparative effectiveness trial of medication (zolpidem or trazodone), cognitive-behavioral therapy for insomnia (CBT-I), and the combination (medication + CBT-I) for the treatment of chronic insomnia in men and women aged 18-80 living in rural areas with 1 year of follow-up. A total of 1200 participants will be enrolled and randomized in the United States. This trial is funded by the Patient-Centered Outcomes Research Institute.
at UCSF
Digital Behavioral Therapy for Sleep Problems
Sorry, accepting new patients by invitation only
Insomnia is very common, especially in HIV population (up to 73%), and contributes to the development of other conditions such as depression, dementia, inflammation, obesity, and heart diseases. Cognitive-behavioral therapy for insomnia (CBT-I) is known to improve insomnia. However, it has never been tested in HIV-positive patients. The investigators aim to examine the Internet version of this therapy in HIV-positive patients because the availability of CBT-I is very limited while the cost is high. The investigators will test this internet version, also called digital CBT-I (dCBTI), against sleep hygiene education (SHE), a commonly prescribed set of instructions in clinical practice, in 60 HIV-positive patients with insomnia invited from the Multicenter AIDS Cohort Study (MACS) Los Angeles site. The investigators aim to test if dCBTI or SHE improves insomnia in this patient group. This trial involves a behavioral treatment that can be done from home with minimal side effects and includes neither medications nor invasive interventions. Lastly, this trial will provide important pilot data for a larger trial testing long-term effects of insomnia treatment in HIV-positive patients.
at UCLA
Drug-Induced Sleep Endoscopy for Upper Airway Evaluation in Obstructive Sleep Apnea
Sorry, currently not accepting new patients, but might later
Prospective, interventional cohort study of drug-induced sleep endoscopy (DISE) to evaluate the upper airway in a cohort of obstructive sleep apnea (OSA) surgical patients. This study has investigated the reliability of this technique, demonstrating moderate-substantial interrater and test-retest reliability. This research has also compared DISE findings to those of the lateral cephalogram X-ray and examined DISE findings in individuals who have not responded to previous sleep apnea surgery. These papers have been published and available through PubMed. Additional research is ongoing, with examination of DISE findings, comparison to other evaluation techniques, and the association between DISE findings and surgical outcomes.
at UCLA
Endotype-Targeted Therapy to Rescue OSA Patients Struggling With CPAP Adherence (TOP-CPAP)
Sorry, not yet accepting patients
More than 10% of the US population have obstructive sleep apnea (OSA). Standard of care is therapy with CPAP (continuous positive airway pressure) which virtually eliminates OSA. However, most patients use CPAP only for part of the night (4-5hours) and about 50% patients discontinue CPAP long-term. Alternative therapies are limited, thus many OSA patients remain at risk of OSA sequelae (e.g. sleepiness, memory issues, high blood pressure, etc.). Importantly, different patients get OSA for different reasons, and recent data show that some of the underlying causes of OSA ("endotypes") such as having a low arousal threshold (i.e. waking up easily) are associated with lower CPAP adherence. Using a randomized controlled trial design, this will be the first study using a targeted intervention to manipulate the underlying OSA causes (i.e., giving a safe hypnotic to patients with OSA to increase the arousal threshold) to test the hypothesis that endotype-targeted therapy increases CPAP-adherence in patients who have low but continued CPAP usage. Ultimately, this strategy may improve the care and outcomes of millions of undertreated OSA patients.
at UCSD
Endotypic Traits and Obstructive Sleep Apnea Surgery
Sorry, not yet accepting patients
This study will examine factors associated with outcomes after soft palate surgery and medications (acetazolamide, eszopiclone) that may treat other potential causes of obstructive sleep apnea (loop gain, arousal threshold).
at UCLA
Extracellular microRNA: Biomarkers of Endothelial Dysfunction in Obese Adolescents & Adults With Obstructive Sleep Apnea
Sorry, not yet accepting patients
Using a prospective observational approach and a clinical trial design comparing the effectiveness of continuous positive airway pressure to diet and exercise, investigators plan to evaluate how obstructive sleep apnea (OSA) leads to endothelial dysfunction in adolescents and young adults and whether treatment of OSA can improve endothelial dysfunction. Concurrently, investigators will measure miR 92a/miR 210 levels in all subjects at baseline and following therapy to determine whether miR 92a/miR 210 levels reliably predict endothelial dysfunction in patients and responses to therapy.
at UCSD
Gabapentin and Tizanidine for Insomnia in Chronic Pain
Sorry, accepting new patients by invitation only
This is a double-blind, placebo-controlled, randomized, crossover trial aimed at assessing the effect of gabapentin and tizanidine, two pain medications, on insomnia in chronic pain patients.
at UCSD
Obstructive Sleep Apnea Treatment in Serious Mental Illness
Sorry, not yet accepting patients
Serious mental illnesses (SMI) like schizophrenia and bipolar disorder are two of the most disabling and costly chronic illnesses worldwide. A high proportion of adults with schizophrenia and bipolar disorder have sleep disorders, like obstructive sleep apnea (OSA), but tend to be underdiagnosed and undertreated compared to the general population. This study aims to examine feasibility, acceptance, and impact of OSA treatment and how it affects cognitive function in people with SMI.
at UCSD
Optimizing Post-operative Recovery in Bariatric Patients With Obstructive Sleep Apnea Undergoing Outpatient Surgery: A Comparison of Sugammadex and Neostigmine
Sorry, in progress, not accepting new patients
This study assesses the efficacy of sugammadex against neostigmine for hastening recovery from neuromuscular blockade and optimizing pulmonary function in obese patients with obstructive sleep apnea presenting for outpatient surgery. Both drugs are used in anesthesiology to reverse neuromuscular blockade that is given in the setting of inducing and maintaining general anesthesia.
at UCSD
RCT of a Weighted Blanket to Reduce Pain in Veterans With Chronic Pain
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Chronic pain is a major health concern for returning Veterans and is associated with decreases in quality of life. In addition, chronic pain is often accompanied by significant disturbance in sleep. Sensory interventions may offer effective, low-cost complementary tools for chronic pain and sleep disturbance in Veterans. Weighted Blankets (WB)- blankets sewn with weighted material inside to provide widespread pressure to the body- are a low-cost wellness product used for anxiety and sleep. WBs have demonstrated large reductions in insomnia, and the investigators have also shown that they can reduce the severity of chronic pain. However, effects and mechanisms of longer WB use have not been examined in individuals with pain and sleep disturbance. The investigators therefore propose a randomized controlled trial examining the effects of WBs on pain and sleep quality in Veterans. the investigators will recruit Veterans with chronic pain and sleep disturbance from the VA San Diego Healthcare System (VASDHS) and VA San Francisco Healthcare System (VASFHS) and randomize 160 Veterans to receive either a light (3-lb; N = 80) or heavy (15-lb; N = 80) blanket. The investigators will remotely collect measures of pain (primary), pain catastrophizing, and pain medication use, as well as sleep disturbance (primary) and sleep efficiency and total sleep time over 6 weeks of overnight home use of the assigned blanket. The investigators will also explore physiological effects of WBs on sleep quality using actigraphy (exploratory) in VASDHS participants. Ecological momentary assessment (EMA) methods will be deployed via smartphone to capture study adherence.
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Sleep Without Insomnia or The Use of Chronic Hypnotics
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Sleeping medications, called hypnotics, are often prescribed for insomnia and are associated with adverse health outcomes in older adults. Response rates to hypnotic discontinuation programs are often inadequate, and many patients eventually resume use of hypnotics, suggesting that other mechanisms need to be targeted to achieve and sustain high rates of non-use. Current programs focus on the tapering of hypnotics and/or the treatment of insomnia symptoms. These programs employ strategies such as supervised gradual taper, cognitive behavioral therapy targeting hypnotic withdrawal, and/or cognitive behavioral therapy for insomnia. Evidence suggests that another mechanism involving "placebo" effects may be a viable target for achieving and sustaining higher discontinuation rates. Cognitive expectancies play a key role in producing placebo effects, which are characterized as real improvements in sleep arising from psychosocial aspects of treatment rather than drug effects alone. In this study, investigators are comparing two programs for discontinuing hypnotic medications-a program that addresses placebo effects associated with hypnotic use and a program that does not address these effects.
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Sleep-SMART for Veterans
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Cognitive Behavioral Therapy for Insomnia (CBT-I) is the first-line treatment for chronic insomnia. However, cognitive impairments may limit progress in CBT-I for older Veterans with Mild Cognitive Impairment (MCI). This study will develop and pilot test Sleep-SMART (Sleep Symptom Management and Rehabilitation Therapy), an adapted CBT-I treatment that incorporates Cognitive Symptom Management and Rehabilitation Therapy (CogSMART) principles with a goal of improving sleep treatment and rehabilitation outcomes for Veterans with co-occurring MCI and insomnia. The innovation of this study centers on enhancing CBT-I by providing supportive cognitive strategies designed to improve treatment adherence, learning, and acceptability. The investigators anticipate that by improving sleep it can concurrently improve daily functioning, increase quality of life, prevent or reduce late-life disability, and mitigate long-term cognitive decline in this Veteran population.
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Tai Chi Effects on Chronic Insomnia in Breast Cancer Survivors: Immune Mechanisms
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Breast Cancer is the most common cancer in women. After completion of successful therapy, may behavioral symptoms persist with over 20% of breast cancer survivors reporting chronic insomnia of greater than 6 months duration that fulfils clinical diagnostic criteria with associated functional limitations, decreased quality of life, and possible effects on long-term survival. Behavioral interventions are highly efficacious in the treatment of insomnia and preferred over hypnotic medication when insomnia is chronic. However, insomnia studies conducted in cancer are scarce. The proposed research builds upon program of study that has examined the efficacy of mind-body intervention, Tai Chi Chih (TCC), on health outcomes including sleep impairments. Preliminary studies show that TTC, a slow moving meditation, contributes to improvement in subjective sleep quality, sleep amounts and sleep efficiency. The investigators have further found that sleep, fatigue and proinflammatory cytokine activity are reciprocally related and that TCC decreases the mechanism through TCC carries its effects on sleep outcomes.
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The Cardiovascular Consequences of Sleep Apnea Plus COPD (Overlap Syndrome)
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Aim 1: The Investigators will perform a cross-sectional study to examine vascular risk in individuals with OVS compared with matched individuals with OSA alone or COPD alone. The PI will examine a panel of biomarkers including cardiac magnetic resonance imaging (right ventricular mass primary outcome), flow mediated vasodilation, plasma biomarkers (BNP, troponin, hsCRP, ST2, galectin3, miR-210). This aim will allow the team to test the hypothesis that individuals with OVS have increased vascular risk compared with matched individuals with OSA alone or COPD alone. This aim will also allow the team to compare the magnitude of the effect of OSA vs. COPD vs OVS for design of subsequent basic and clinical studies. Aim 2: The Investigators will perform an interventional study in individuals with OVS to compare the impact of bi-level therapy with that of oxygen therapy (the current standard of care). The team will assess the same panel of biomarkers as in Aim 1 to determine the impact of treatment on the observed abnormalities. This aim will allow the team to test the hypothesis that bi-level therapy is superior to oxygen in the treatment of individuals with OVS from the standpoint of right ventricular mass and other cardiovascular risk parameters/outcomes. Our assessments of biomarkers will help to define potential causal pathways for our findings and will allow determination of appropriate biomarkers for subsequent multicenter studies.
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The Effect of Obstructive Sleep Apnea and Its Treatment on Decision Making
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Obstructive sleep apnea (OSA) is an extremely common disease with inadequately explored neurocognitive consequences. The investigators will study OSA patients before and after treatment to understand how OSA changes decision making abilities, and whether treatment can reverse such cognitive changes. These results could provide deeper insight into how OSA affects decision making either temporarily or permanently, and provide another rationale or motivation for treatment of OSA in adults.
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Underlying Mechanisms of Obesity-induced Obstructive Sleep Apnea
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Obesity is a common risk factor for the development of obstructive sleep apnea. However, not all subjects with obesity develop obstructive sleep apnea. This study will attempt to determine the mechanistic drivers between obesity and obstructive sleep apnea.
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Our lead scientists for Sleep Disorders research studies include Dawn Meyer, PhD Liviu Klein, MD Michael R Harrison, MD Michael R. Irwin, MD Neal Rao, MD Wade Smith, MD, PhD Heather Huddleston, MD Aric Prather, PhD Constance Fung, MD, MSHS Andrew Krystal, MD Henry J. Orff, PhD Masaki Nagamine, MD Jeremy Orr, MD Peter Colvonen, PhD Rajesh Kumar, PHD Linda L Chao, PhD Laura K Case, PhD Robert L. Owens Ellen Lee Shira Maguen, PhD Andrew Fuligni, Ph.D. Kwan Ng, MD Rakesh Bhattacharjee Jennifer N Felder, PhD Emily J Ricketts, PhD Christopher Schmickl, MD, PhD Anne Richards, MD, MPH Kathleen Fumiko Sarmiento, MD MPH Jean-Marc Schwarz, PhD Rachel Willard-Grace, MPH Eric J Kezirian, MD, MPH Atul Malhotra Sabra S Inslicht, PhD Nathaniel Schuster, MD Carl J Stepnowsky, Jr., PhD Monica Kelly, PhD Alon Avidan, MD Lauren Asarnow, PhD Lizabeth A Goldstein, PhD Mariana Cherner, PhD.
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