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137 Sleep Trials

Power is an online platform that helps thousands of Sleep patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.

Sleep deprivation is a major problem in military populations. Some major consequences of sleep loss are inability to concentrate, poor work efficiency, and increase in errors during daily tasks. Ketogenic supplementation is speculated to alleviate some sleep deprivation issues via action of ketones. Ketones are small molecules that appear in the blood when following a ketogenic diet or consuming ketone supplements. The goal of this project is to find out if diet and/or ketones can improve sleep deprivation detriments over 5 days of sleep restriction (-50% from habitual sleep).
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 40
Sex:All
60 Participants Needed
Sleep deprivation is a major problem in military populations. Some major consequences of sleep loss are inability to concentrate, poor work efficiency, and increase in errors during daily tasks. There is some evidence that ketone ester supplements may lessen the adverse effects of sleep restriction. The main purpose of these supplements is to raise your blood concentration of ketones, which are safe, small molecules that appear in the blood during fasting, when following a ketogenic diet, or consuming ketone supplements. The main purpose of this study is to examine if ingesting a ketone ester supplement, twice daily, can improve cognitive and physical performance during short-term sleep restriction.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 40
Sex:All
60 Participants Needed
The purpose of this feasibility study is to assess whether an alternative transvenous lead location affects respiration and airway physiology during a commercial remedē® System or commercial transvenous cardiac device (de novo pacemaker or implantable cardiac defibrillator) implant procedure.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18+
Sex:All
30 Participants Needed
This trial tests the aerSleep® II device, which helps people with sleep apnea breathe better at night. It targets adults who can't use the usual CPAP therapy. The device works by keeping the airway open during sleep.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:18+
Sex:All
900 Participants Needed
A multicenter study to assess the safety and effectiveness of the Genio dual-sided hypoglossal nerve stimulation system for the treatment of obstructive sleep apnea in adults subjects.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:22 - 75
Sex:All
115 Participants Needed
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 (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.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18+
Sex:All
3062 Participants Needed
This study is an exploratory, multicenter study of up to 300 subjects diagnosed with obstructive sleep apnea who are being evaluated for airway surgery. Subjects will undergo standard evaluation for airway surgery as part of standard of care. In addition to the standard airway assessment, a simple, non-invasive measurement of the width of the inside of each subjects mouth will be performed. This measurement takes 2-3 minutes to perform.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18+
Sex:All
300 Participants Needed
A randomized controlled trial of 1,500 women to assess whether treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP) in pregnancy will result in a reduction in the rate of hypertensive disorders of pregnancy.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18+
Sex:Female
1500 Participants Needed
Lower attainment of cardiovascular health (CVH), indicated by the American Heart Association's Life's Simple 7 (LS7; physical activity, diet, cholesterol, blood pressure, body mass index, smoking, glycemia) and Life's Essential 8 (LE8; LS7+sleep) metrics, is a major contributor to Black men having the shortest life-expectancy of any non-indigenous race/sex group. Unfortunately, a paucity of literature exists on interventions aimed at improving CVH among Black men. The team of clinician scientists and community partners co-developed a community-based lifestyle intervention titled Black Impact: a 24-week intervention for Black men with less-than-ideal CVH (\<4 LS7 metrics in the ideal range) with 45 minutes of weekly physical activity, 45 minutes of weekly health education, and engagement with a health coach, group fitness trainer, and community health worker. Single-arm pilot testing of the intervention (n=74) revealed high feasibility, acceptability, and retention and a 0.93 (95% confidence interval: 0.40, 1.46, p\<0.001) point increase in LS7 score at 24 weeks. Secondary outcomes included improvements in psychosocial stress (i.e., perceived stress, depressive symptoms), patient activation, and social needs. Thus, robustly powered clinical trials are needed to determine the efficacy of Black Impact and to evaluate the underlying interpersonal and molecular pathways by which Black Impact improves psychosocial stress and CVH. Thus, the investigators propose a randomized, wait-list controlled trial of Black Impact. This novel, community-based intervention to provide a scalable model to improve CVH and psychosocial stress at the population level and evaluate the biological underpinnings by which the intervention mitigates cardiovascular disease risk. The proposed study aligns with American Heart Association's commitment to addressing CVH equity through innovative, multi-modal solutions.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18+
Sex:Male
340 Participants Needed
This study will test the effectiveness of a sleep-related primary suicide prevention program entitled TAILOR (Targeting Adolescent Insomnia to Lessen Overall Risk of Suicidal Behavior), which includes specific behavior-change strategies for adolescents at risk of suicidal behavior who suffer from difficulties falling asleep, staying asleep, and/or insufficient sleep.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:11 - 18
Sex:All
190 Participants Needed
This trial is testing the safety and effectiveness of pitolisant, a medication that helps people stay awake, in adults with idiopathic hypersomnia. These patients have already completed an earlier part of the study. Pitolisant works by boosting brain chemicals that make you feel more alert. It has been approved for the treatment of narcolepsy in adults.
No Placebo Group
Prior Safety Data
Pivotal Trial
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:18+
Sex:All
128 Participants Needed
Every participant will receive Metaxalone in two (2) stages, one week after the other. A single dose of each Metaxalone dose will be taken one (1) time after a high fat meal which must be eaten within 30 minutes. Every participant will be given written tests to measure drowsiness, reaction time and thinking process and will also be asked to take walking tests to assess fall risk. Participation in this study will last approximately 2-4 weeks.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:18 - 55
Sex:All
20 Participants Needed
The purpose of this study is to continue to measure the safety, tolerability, and durability of treatment effect in subjects with Narcolepsy Type 1 (NT1) or Narcolepsy Type 2 (NT2) when taking ALKS 2680 tablets
No Placebo Group
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2, 3
Age:18 - 70
Sex:All
256 Participants Needed
This trial is testing a specific combination of medications called AD109 to see if it helps people with Obstructive Sleep Apnea. The goal is to find out if AD109 can keep airways open during sleep. The study will last for several months and compare the effects of AD109.
Pivotal Trial
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:18+
Sex:All
660 Participants Needed
This study will assess the safety and efficacy of JZP258 (XYWAV) on sleepiness, polysomnography, and functional outcomes in patients with idiopathic hypersomnia (IH) or narcolepsy.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 4
Age:18 - 75
Sex:All
207 Participants Needed
This trial is testing a skin cream called ruxolitinib to see if it can help people with Atopic Dermatitis sleep better by reducing inflammation and itching. Ruxolitinib cream is used to treat inflammatory skin diseases like atopic dermatitis.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:18+
Sex:All
100 Participants Needed
The goal of this randomised, double-blind phase II/III clinical trial is to determine the safety and efficacy of IHL-42X in subjects with obstructive sleep apnoea who are intolerant, non-compliant, or naïve to positive airway pressure. Phase II study will be a 4-week dose-finding study comparing two dose strengths of IHL-42X to placebo. The optimal dose strength will be selected based on comparing the safety and efficacy of the two IHL-42X dose strengths to placebo over a 4-week treatment period. The three treatment groups are; IHL-42X Low dose (2.5mg dronabinol, 125mg acetazolamide), IHL-42X High dose (5mg dronabinol, 250mg acetazolamide) and Placebo. Each treatment group will enrol approximately 40 patients per treatment arm, for a total of approximately 120 patients. The safety and efficacy results of the Phase II study will be used to select the dose strength of IHL-42X and corresponding doses of dronabinol and acetazolamide in Phase III. Phase III study will use the optimal dose strength of IHL-42X identified in Phase II and will be compared to the component active pharmaceutical ingredients at equivalent dose strengths to those found in the IHL-42X optimal dose strength and placebo over 52 weeks. The four treatment groups are; IHL-42X (optimal dose from Phase II), Acetazolamide (equivalent dose strength to that in the IHL-42X optimal dose strength), Dronabinol (equivalent dose strength to that in the IHL-42X optimal dose strength) and placebo. The treatment groups will enrol approximately 165 patients in IHL-42X, approximately 55 patients in dronabinol, approximately 55 in acetazolamide, and approximately 165 in placebo, for a total of approximately 440 patients.
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2, 3
Age:18+
Sex:All
560 Participants Needed
This is a Phase 3 Randomized Double-Blind Placebo-Controlled 6-month Parallel-Arm Study to Compare a Fixed Dose Combination of AD109 to Placebo in Obstructive Sleep Apnea.
Pivotal Trial
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:18+
Sex:All
740 Participants Needed
This trial tests a pill called tasimelteon in people who have trouble falling asleep and waking up at normal times. The goal is to see if tasimelteon can help reset their sleep schedule. Both men and women with this sleep disorder are included in the study.
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:18 - 75
Sex:All
70 Participants Needed
The primary purpose of this study is to evaluate the effectiveness of sivopixant, acetazolamide and SASS-001 in adults with sleep apnea with a central component.
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Phase 2
Age:18 - 80
Sex:All
60 Participants Needed
Conducting a randomized control trial of oxygen in children with Down syndrome to treat moderate to severe obstructive sleep apnea. The aim of the study is to conduct a comparison between the 2 methods of oxygen delivery during sleep in 15 children from Cincinnati Children's Hospital and Children's Hospital of Los Angeles. 2 polysomnographies will be performed, one with continuous flow and the second with pulse flow.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:5 - 17
Sex:All
10 Participants Needed
The combination drug composed of aroxybutynin and atomoxetine, designated AD109, is being developed by Apnimed for the treatment of obstructive sleep apnea (OSA). The present study is a Phase 3 open label continuation protocol enrolling qualifying participants who completed one of the parent Phase 3 double-blind placebo-controlled studies, APC-APN-304 or APC-APN-305.
No Placebo Group
Pivotal Trial
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Phase 3
Age:18+
Sex:All
1280 Participants Needed
To create a validated computational tool to predict surgical outcomes for pediatric patients with obstructive sleep apnea (OSA). The first line of treatment for children with OSA is to remove their tonsils and adenoids; however, these surgeries do not always cure the patient. Another treatment, continuous positive airway pressure (CPAP) is only tolerated by 50% of children. Therefore, many children undergo surgical interventions aimed at soft tissue structures surrounding the airway, such as tonsils, tongue, and soft palate, and/or the bony structures of the face. However, the success rates of these surgeries is surprisingly low. Therefore, there a need for a tool to improve the efficacy and predict which surgical option is going to benefit each individual patient most effectively. Computational fluid dynamics (CFD) simulations of respiratory airflow in the upper airways can provide this predictive tool, allowing the effects of various surgical options to be compared virtually and the option most likely to improve the patient's condition to be chosen. Previous CFD simulations have been unable to provide information about OSA as they were based on rigid geometries, or did not include neuromuscular motion, a key component in OSA. This project uses real-time magnetic resonance imaging (MRI) to provide the anatomy and motion of the airway to the CFD simulation, meaning that the exact in vivo motion is modeled for the first time. Furthermore, since the modeling is based on MRI, a modality which does not use ionizing radiation, it is suitable for longitudinal assessment of patients before and after surgical procedures. In vivo validation of these models will be achieved for the first time through comparison of CFD-based airflow velocity fields with those generated by phase-contrast MRI of inhaled hyperpolarized 129Xe gas. This research is based on data obtained from sleep MRIs achieved with the subject under sedation. While sedating the patient post-operatively is slightly more than minimal risk, the potential benefits to each patient outweigh this risk. As 58% of patients have persistent OSA postsurgery and the average trajectory of OSA severity is an increase over time, post-operative imaging and modeling can benefit the patient by identifying the changes to the airway made during surgery and which anatomy should be targeted in future treatments.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:3 - 18
Sex:All
120 Participants Needed
The purpose of this study is to obtain additional long-term safety and efficacy data on the use of Inspire therapy.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:22+
Sex:All
127 Participants Needed
SUSTAIN (Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder) is a Phase 3, multi-center, randomized, double-blind, placebo-controlled, parallel- group trial to assess the efficacy and safety of solriamfetol in adults with excessive sleepiness associated with shift work disorder (SWD).
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:18 - 65
Sex:All
520 Participants Needed
The platform protocol is designed to be flexible so that it is suitable for a range of study settings and intervention types. Therefore, the platform protocol provides a general protocol structure that can be shared by multiple interventions and allows comparative analysis across the interventions. For example, objectives, measures, and endpoints are generalized in the platform protocol, but intervention-specific features are detailed in separate appendices. This platform protocol is a prospective, multi-center, multi-arm, randomized controlled platform trial evaluating potential interventions for PASC-mediated sleep disturbances. The hypothesis is that symptoms of sleep and circadian disorders that emerge in patients with PASC can be improved by phenotype-targeted interventions. Specific sleep and circadian disorders addressed in this protocol include sleep-related daytime impairment (referred to as hypersomnia) and complex PASC-related sleep disturbance (reflecting symptoms of insomnia and sleep-wake rhythm disturbance).
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18+
Sex:All
1074 Participants Needed
The U.S. registered nurse (RN) workforce is the largest in the Healthcare and Social Assistance Sector and is at high risk for injuries and errors due to poor sleep and fatigue. Shift work (i.e., nights, evenings, rotating shifts) can contribute to RNs not obtaining adequate, restful sleep. Work intensity, including heavy physical and emotional workloads of caring for critically ill patients, can contribute to job stress, resulting in spill-over effects at home when RNs experience difficulties falling and staying asleep. To address work and home sleep barriers, this project proposes the development and pilot testing of RN-SLEEP, a skill-building mobile application designed to improve sleep. RN-SLEEP will provide a convenient, flexible space to learn sleep-enhancing evidence-based shift work-specific strategies, and cognitive-behavioral methods, (e.g., goal setting, relaxation training). Using NIOSH's Research 2 Practice (R2P) approach, the study team will collaborate with participants (N=18-24) from an RN union to refine RN-SLEEP content, integrating current sleep literature (including National Institute for Occupational Safety and Health \[NIOSH\] material) with cognitive-behavioral based training. RN-SLEEP will be pilot-tested using a two-group pretest-posttest study design, comparing sleep outcome measures (duration, quality) of RN-SLEEP participant users (n=38) with participants from an education control group (n=38). Data trends on fatigue, what drives behavior change (beliefs and self-efficacy), and other sleep outcome measures (timing, regularity, efficiency, daytime sleepiness) will be explored. RN-SLEEP goals align with Healthy People 2030, NIOSH's strategic goal to promote safe and healthy work design and well-being through two NIOSH Healthcare and Social Assistance Sector/Healthy Work Design Cross-Sector (HCSA/HWD) intermediate goals. HWD goal 7.2A is to conduct intervention research addressing fatigue (poor sleep sequela) due to suboptimal work designs (shift work) in the healthcare industry. HCSA/HWD goal 7.12A prioritizes interventions designed to impact work and non-work contributors to safety and health. This RN-SLEEP intervention aims to improve sleep by building skills that help RNs overcome obstacles to sleep from work and home, thus improving health and safety. Immediate outputs include a mobile app, designed and tested in collaboration with RNs, to improve sleep. Study results will be disseminated through our union collaborators, nursing conferences and journal publications, and our University's NIOSH-sponsored Education and Research Center social media outlets. Intermediate outcomes include enhancing RN sleep through training rarely available in nursing schools and traditional hospital health and safety training programs. Improving sleep can reduce fatigue and may decrease occupational injuries and errors. RN-SLEEP is adaptable, where future versions could be modified to meet the needs of other HCSA workers (i.e., nursing aides) and workers in other industries (e.g., oil and gas) scheduled to work non-standard work hours. End outcomes include integrating RN-SLEEP into a broader hospital organization intervention to mitigate fatigue risks.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Unphased
Age:18+
Sex:All
76 Participants Needed
There is strong reason to believe that sleep promotion during adolescence could yield long-term health rewards; the investigators' data show that, when they get more sleep, Morning Larks have impressively reduced intake of overall calories and foods high in glycemic load that are linked to long-term health risk. Before that can be translated into major public health interventions, however, the field needs to understand why similar changes in sleep had no effect, or even an adverse effect, on adolescent Night Owls. This experimental study will clarify why there have been such discrepant effects across Morning Larks and Night Owls, with the goal of more broadly harnessing the promise of improved sleep in the prevention of obesity and long-term morbidity.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:14 - 18
Sex:All
204 Participants Needed
Study GZRA is a master protocol that will support 2 independent studies, GZ01 and GZ02. Participants will be assigned to the appropriate study prior to randomization. The purpose of the studies is to evaluate the efficacy and safety of orforglipron in participants who have moderate-to-severe OSA and obesity or overweight. Study GZ01 will include participants who are unable or are unwilling to use PAP therapy. Study GZ02 will include participants who are on PAP therapy for at least 3 months at time of screening and plan to continue PAP therapy during the study.
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:18+
Sex:All
600 Participants Needed
This trial is testing retatrutide, a medication for people with type 2 diabetes who are overweight or obese, including some with sleep apnea. The medication aims to help control blood sugar levels and may also aid in weight loss.
Pivotal Trial
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:18+
Sex:All
1000 Participants Needed
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Frequently Asked Questions

How much do Sleep clinical trials pay?

Each trial will compensate patients a different amount, but $50-100 for each visit is a fairly common range for Phase 2–4 trials (Phase 1 trials often pay substantially more). Further, most trials will cover the costs of a travel to-and-from the clinic.

How do Sleep clinical trials work?

After a researcher reviews your profile, they may choose to invite you in to a screening appointment, where they'll determine if you meet 100% of the eligibility requirements. If you do, you'll be sorted into one of the treatment groups, and receive your study drug. For some trials, there is a chance you'll receive a placebo. Across Sleep trials 30% of clinical trials have a placebo. Typically, you'll be required to check-in with the clinic every month or so. The average trial length for Sleep is 12 months.

How do I participate in a study as a "healthy volunteer"?

Not all studies recruit healthy volunteers: usually, Phase 1 studies do. Participating as a healthy volunteer means you will go to a research facility several times over a few days or weeks to receive a dose of either the test treatment or a "placebo," which is a harmless substance that helps researchers compare results. You will have routine tests during these visits, and you'll be compensated for your time and travel, with the number of appointments and details varying by study.

What does the "phase" of a clinical trial mean?

The phase of a trial reveals what stage the drug is in to get approval for a specific condition. Phase 1 trials are the trials to collect safety data in humans. Phase 2 trials are those where the drug has some data showing safety in humans, but where further human data is needed on drug effectiveness. Phase 3 trials are in the final step before approval. The drug already has data showing both safety and effectiveness. As a general rule, Phase 3 trials are more promising than Phase 2, and Phase 2 trials are more promising than phase 1.

Do I need to be insured to participate in a Sleep medical study ?

Clinical trials are almost always free to participants, and so do not require insurance. The only exception here are trials focused on cancer, because only a small part of the typical treatment plan is actually experimental. For these cancer trials, participants typically need insurance to cover all the non-experimental components.

What are the newest Sleep clinical trials ?

Most recently, we added Acetazolamide for Central Sleep Apnea in Opioid Users, Collaborative Care Intervention for Cancer and Multi-Sensor Sleep Tracking for Nightshift Work to the Power online platform.