Sleep Deprivation

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Review clinical trials related to Sleep Deprivation. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

Evolution of Sleep in Intensive Care Unit Patients

Sleep plays a key role in immune, metabolic, and neurological regulation, particularly in critically ill patients. However, the intensive care environment significantly disrupts sleep due to noise, light exposure, and frequent medical interventions, leading to circadian rhythm disturbances. Poor sleep in ICU patients is associated with increased morbidity, mortality, prolonged mechanical ventilation, and long-term psychological complications. Current studies report fragmented sleep with reduced deep sleep stages but are limited by short monitoring periods and small sample sizes. No study has yet assessed longitudinal sleep evolution throughout ICU stay. This study aims to characterize sleep dynamics from the acute phase to recovery using a simplified EEG device (Sleepscan®). Sleep will be recorded during the first three nights and the last night before ICU discharge. Environmental factors (noise, light) and clinical data will also be collected. This longitudinal intra-individual analysis will identify critical periods of sleep disruption. Results may guide future targeted interventions to improve sleep quality and patient outcomes in ICU.

Participants needed: 40
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Centre Hospitalier Universitaire de Saint EtienneUpdated: Oct 9, 2026Locations: 1
Eligibility criteria

Adult patients [+3]

Acute brain injury or neurological disease (stroke, meningitis, neurodegenerativ... [+4]

Status: Recruiting

Mind After Midnight

This study examines whether wakefulness during the biological night (2:00-4:00 AM) is associated with increased negative mood, impaired decision-making, and suicidal thoughts. Adults with a history of suicidal ideation in the past six months will complete laboratory and home-based assessments under varying levels of sleep pressure. Participants will be evaluated during late-night wakefulness and under conditions of both higher and lower sleep pressure. The goal of the study is to better understand the biological and behavioral mechanisms that may contribute to elevated suicide risk during nocturnal wakefulness.

Participants needed: 90
Trial details
Age: 18-55Biological sex: AllType: InterventionalSponsor: University of ArizonaUpdated: Oct 1, 2026Locations: 1
Eligibility criteria

Age 18-55 years [+4]

Current suicidal intent requiring immediate clinical intervention [+7]

Status: Recruiting

Study of Single Doses of HBS-104 in Acutely Sleep-deprived Healthy Participants

This is a study to evaluate the pharmacodynamic effects, safety, tolerability, and pharmacokinetics of HBS-104 in acutely sleep-deprived healthy adult participants.

Participants needed: 12
Trial details
Phase: Phase 1Age: 18-55Biological sex: AllType: InterventionalSponsor: Harmony Biosciences Management, Inc.Updated: Sep 30, 2026Locations: 1
Eligibility criteria

Provide written informed consent before any study-related procedures are perform... [+1]

Female with a positive pregnancy test at Screening Visit or upon check-in for Pe... [+1]

Status: Not yet recruiting

Sleep Harmonization Via Bundled Team-Based Interventions in the ICU

SHANTI-ICU compares the effectiveness of two evidence-based multicomponent ICU sleep promotion bundles on delirium and patient-reported sleep quality in critically ill adults. Bundle A is a non-pharmacologic strategy. Bundle B includes all components of Bundle A plus pharmacist-led pharmacologic strategies. Sixteen intensive care units across eight hospitals implement one of the two bundles as a unit-level change to routine care, using a concurrent multiple-intervention stepped wedge randomized design. The primary outcome is delirium incidence, measured using the Confusion Assessment Method for the ICU (CAM-ICU) as documented during routine clinical care. Secondary outcomes are delirium duration, ICU length of stay, nightly patient-reported sleep quality, and overall patient-reported ICU sleep quality. Patients receive the assigned bundle as part of routine care. The study operates under an IRB-approved waiver of informed consent and waiver of HIPAA authorization; there is no individual enrollment procedure.

Participants needed: 62,500
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: University of California, San DiegoUpdated: Sep 25, 2026Locations: 8
Eligibility criteria

Age 18 years or older [+1]

Age less than 18 years [+1]

Status: Recruiting

Modafinil to Optimize the Performance of Cold-Stressed Sleep-Deprived Personnel

Environmental and workplace stressors are common and often unavoidable in military operations. Two critical stressors are cold stress and sleep loss. They both can substantially degrade operational effectiveness. Various countermeasures are available to mitigate the adverse effects of these stressors, but due to operational requirements many are of limited use in the field. Modafinil is a drug that mitigates the effects of sleep deprivation and potentially cold stress, and modafinil may prevent performance degradation due to the combination of these stressors. This study will help determine if modafinil alters body-heat production and prevents cognitive and physical performance degradation due to cold stress in rested and sleep-deprived volunteers.

Participants needed: 33
Trial details
Phase: Phase 4Age: 17-39Biological sex: AllType: InterventionalSponsor: United States Army Research Institute of Environmental MedicineUpdated: Sep 21, 2026Locations: 1
Eligibility criteria

Healthy, men and women aged 18-39 years old. Active-duty military personnel who... [+5]

Use of modafinil or armodafinil in the last 3 months. [+22]

Status: Not yet recruiting

The Neurocognitive Effects of Total and Partial Sleep Deprivation in Younger Adults.

This study aims to examine how total and partial sleep deprivation affect brain function, cognitive performance, and biomarkers related to stress and inflammation in the same participants using a crossover design. The study will also compare the effects of total and partial sleep deprivation to determine whether these conditions affect the brain and body differently. The findings may improve our understanding of the consequences of sleep deprivation and help inform strategies to reduce its negative impact on health and society. * How does total versus partial sleep deprivation affect brain activity during rest and cognitive tasks? * How does sleep deprivation affect functional connectivity between brain networks? * How does sleep deprivation affect working memory, attention, and executive control? * How does sleep deprivation affect biomarkers of stress and inflammation, such as cortisol? * Are changes in brain activity and connectivity associated with changes in cognitive performance and biological markers? * Can combining MRI-based and non-MRI-based measures provide a more complete picture of the effects of sleep deprivation? Participants will complete three study conditions in a randomized order: Total Sleep Deprivation (TSD): 28 to 32 hours of continuous wakefulness. Partial Sleep Deprivation (PSD): sleep restricted to 4 hours per night for two consecutive nights. Normal Sleep (control condition): a night of habitual sleep without sleep restriction.

Participants needed: 24
Trial details
Age: 20-40Biological sex: AllType: InterventionalSponsor: Örebro University, SwedenUpdated: Sep 16, 2026Locations: 1
Eligibility criteria

Signed informed consent prior to any study-related procedures. [+3]

Current diagnosis of a psychiatric or neurological disorder or syndrome. [+13]

Status: Recruiting

Neurobehavioral Changes Following Spaceflight Stressors

This study aims to investigate the impairing effects of known central nervous system (CNS) stressors in a controlled environment in order to predict and mitigate analogous risks in spaceflight. Up to 56 healthy individuals aged 25-60 will spend approx. 110 hours in a laboratory, where they will be exposed to 27 hours of sleep deprivation and will consume alcohol to reach a BAC of 0.08 on a separate day. They will perform cognitive and sensorimotor tasks and undergo MRIs and blood draws.

Participants needed: 56
Trial details
Age: 21-60Biological sex: AllType: InterventionalSponsor: University of PennsylvaniaUpdated: Aug 6, 2026Locations: 1
Eligibility criteria

Age between 21-60 years. [+6]

Alcohol or drug abuse in the past year based upon history and urine toxicology s... [+19]

Status: Recruiting

Effect of Sleep Extension on Ceramides in People With Overweight and Obesity

The overall goal is to determine how a sleep extension intervention (increasing time in bed) in individuals who maintain less than 6.5 hours sleep per night affects their plasma ceramides and insulin sensitivity. Participants will undergo a randomized controlled trial, with sleep extension (intervention) and healthy lifestyle (control) groups. The sleep extension is designed to increase participant's time in bed by 2 hours per night. Alternatively, the control group will receive basic health information (e.g., physical activity, goal setting, and nutrition when eating out).

Participants needed: 70
Trial details
Age: 18-45Biological sex: AllType: InterventionalSponsor: University of UtahUpdated: Aug 5, 2026Locations: 1
Eligibility criteria

Age: 18-45 years old; equal numbers of men and women [+2]

Clinically diagnosed sleep disorder or major psychiatric illness [+10]

Status: Recruiting

Ketone Conferred Resiliency Against Sleep Restriction With Nutritional Intervention.

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).

Participants needed: 60
Trial details
Age: 18-40Biological sex: AllType: InterventionalSponsor: Ohio State UniversityUpdated: Jun 24, 2026Locations: 1
Eligibility criteria

Healthy, 18-40 years old. [+4]

<18 or >40 years of age [+10]

Status: Recruiting

Reestablishing Sleep and Circadian Alignment in Medical Intensive Care Unit (MICU) Patients Via a Mechanistic RCT of an Sleep Chronobundle

More than 5 million patients are admitted to the intensive care unit every year in the United States; most of these patients experience profound sleep and circadian disruption. Promotion of circadian alignment (i.e., alignment of the body's clocks) would make it possible to strategically schedule behaviors such as sleep and eating at normal body clock times, which is predicted to improve sleep quality and metabolic function. This project will test the ability of a sleep chronobundle (i.e., sleep promotion and circadian treatment bundle) to normalize circadian alignment and subsequently test if this realignment also improves sleep and metabolism.

Participants needed: 160
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Yale UniversityUpdated: May 20, 2026Locations: 2
Eligibility criteria

Critically ill patients admitted to the MICU who require mechanical ventilation,... [+11]

Status: Recruiting

Effects of Partial Sleep Deprivation on Cardiac Output During Cycling

The goal of this clinical trial is to determine if attenuations in cardiac output drive the blunted blood pressure response during cycling exercise following a night of partial sleep deprivation in young healthy adults (%50 females). The secondary outcome is to assess sex differences. The main questions it aims to answer are: * Do reductions in plasma volume drive reductions in cardiac output and therefore blood pressure during exercise following a night of partial sleep deprivation? * Do sex differences exist? Participants will: * Visit the lab after a night of normal sleep and a night of partial sleep deprivation. * Keep a daily diary of their sleep and food/beverage intake. * Perform maximal and submaximal exercise on a cycle ergometer.

Participants needed: 30
Trial details
Age: 18-50Biological sex: AllType: InterventionalSponsor: University of GuelphUpdated: Apr 28, 2026Locations: 1
Eligibility criteria

Free of known cardiovascular or metabolic diseases or sleep disorders [+6]

Individuals diagnosed with cardiovascular or metabolic disease or sleep disorder... [+6]

Status: Recruiting

The Effect of Sleep Loss on Emotion Regulation

The study is designed to investigate the impact of three nights of sleep restricted to 4 hours per night, on the processing and regulation of emotional information compared to Insomnia Disorder and control. The investigators will address and attempt to answer two questions. (i) How do three nights of reduced sleep or a diagnosis of Insomnia Disorder affect the processing and regulation of emotional information compared to typical, undisturbed sleep? (ii) What overlapping and distinct neural mechanisms are engaged and associated with behavioral effects when attempting to process and regulate emotions in a sleep restricted state or with a clinical diagnosis of Insomnia Disorder? This study will investigate sleep's role in emotion processing and regulation. The findings will help further understanding of the role of sleep in healthy emotional functioning.

Participants needed: 90
Trial details
Age: 18-40Biological sex: AllType: InterventionalSponsor: Beth Israel Deaconess Medical CenterUpdated: Apr 14, 2026Locations: 1
Eligibility criteria

willing and able to follow the protocol [+3]

left-handedness or ambidexterity [+1]

Status: Recruiting

Cardiovascular Risk and Circadian Misalignment in Short Sleepers - Role of Extended Eating Period

Short sleep duration confers high cardiovascular and metabolic risk, but lifestyle factors and molecular mechanisms that contribute to increased blood pressure and poor glucose control during short sleep are not completely understood. Habitual short sleepers are constantly eating, the proposed studies will evaluate if this behavior contributes to heightened cardiovascular and metabolic risk. The study will evaluate if restricted eating duration (8 hours/day) could improve cardiovascular and metabolic health in habitual short sleepers.

Participants needed: 100
Trial details
Age: 18-45Biological sex: AllType: InterventionalSponsor: Pennington Biomedical Research CenterUpdated: Feb 10, 2026Locations: 1
Eligibility criteria

Age: 18-45 years [+9]

Irregular sleep habits / night shift / rotating shift work in past 1 month. [+9]

Status: Recruiting

Nighttime Synchrony of Your Nutrition and Circadian Health

Sleep is an important factor for overall health. This study will see how different light exposure patterns and food intake impact a person's metabolism (how the body breaks down food) when sleeping is reduced. Participants will attend 6 to 8 in-person visits to the study clinic, including three overnight stays. People will complete surveys and medical tests. The study will last about 4 to 6 months.

Participants needed: 120
Trial details
Age: 18-35Biological sex: AllType: InterventionalSponsor: University of UtahUpdated: Jan 22, 2026Locations: 1
Eligibility criteria

Age: 18-35 years old; equal numbers of men and women [+2]

Clinically diagnosed sleep disorder or apnea hypopnea index (AHI) ≥5 [+14]

Status: Recruiting

Effects of Non-Invasive Superficial Craniocervical Lymphatic Drainage (NSCLD) on Memory and Cognitive Function in Adults With Sleep Deprivation: A Proof-of-Concept Study

This Effects of Non-Invasive Superficial Craniocervical Lymphatic Drainage (NSCLD) on Memory and Cognitive Function in Adults with Sleep deprivation: A Proof-of-Concept Study aims to investigate the effects of Non-Invasive Superficial Craniocervical Lymphatic Drainage (NSCLD) on memory and cognitive function in adults experiencing sleep deprivation(SD). Given the known impact of SD on cognitive performance, this study seeks to explore whether NSCLD, as a non-invasive intervention, can mitigate the cognitive impairments associated with SD.

Participants needed: 30
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Tao LiuUpdated: Jan 13, 2026Locations: 1
Eligibility criteria

College student ≥18 years, all of whom have passed a standardized entrance exami... [+6]

Pregnant or breastfeeding women. [+4]

Status: Recruiting

Circadian Rhythms and Time Perception in Healthy Adults During Constant Wakefulness

This study examines how the internal body clock (circadian rhythms) influences the way healthy adults experience time, think, and feel when they stay awake for an extended period. Participants will spend about 36 hours in a controlled sleep laboratory while remaining awake the entire time. Light, posture, food intake, and activity are kept as constant as possible (a "constant routine") so that changes over time mainly reflect the body's internal clock and increasing sleepiness, rather than changes in the environment. Every two hours, participants complete a brief test battery that includes ratings of sleepiness and mood, a reaction-time task, and short tasks that assess how fast or slow time seems to pass, how accurately they can estimate time intervals, how they respond to simple decisions, and how they judge colours. Saliva samples are collected repeatedly to measure melatonin, a hormone that indicates circadian phase. By comparing changes in behaviour, perception, and melatonin levels across the 36-hour wake period, the study aims to identify when during the circadian cycle people are most vulnerable to distortions in time perception and reduced alertness. The findings may help improve scheduling of shift work and other activities that require sustained wakefulness.

Participants needed: 30
Trial details
Age: 23-45Biological sex: AllType: InterventionalSponsor: University of AarhusUpdated: Dec 22, 2025Locations: 1
Eligibility criteria

Age 23 to 45 years. [+9]

Any known or suspected major sleep disorder (e.g., insomnia disorder, obstructiv... [+9]

Status: Recruiting

Effects of Acute Sleep Deprivation on Individuals With Different APOE Genotypes

This study aims to investigate the effects of 24-hour acute sleep deprivation on plasma Alzheimer's disease biomarkers and multi-omics in individuals with different APOE genotypes, to elucidate the potential role of acute sleep deprivation in AD risk.

Participants needed: 60
Trial details
Age: 18-40Biological sex: AllType: InterventionalSponsor: Yuhui QiuUpdated: Dec 24, 2025Locations: 1
Eligibility criteria

Age 18-40 years, gender not limited [+4]

Presence of day-night sleep reversal [+8]

Status: Not yet recruiting

Evaluation of Sex Differences in Glucose Metabolism in Response to Sleep Curtailment

The goal of this study is to learn whether insufficient sleep affects glucose metabolism differently in healthy men and women.

Participants needed: 32
Trial details
Age: 20-40Biological sex: AllType: InterventionalSponsor: Brigham and Women's HospitalUpdated: Dec 10, 2025Locations: 1
Eligibility criteria

Healthy adults with conventional sleep-wake timing [+4]

History of neurological or psychiatric disorder [+8]

Status: Recruiting

Immune Status After Being on Call for 24 Hrs

Sleep deprivation is a prevalent problem in modern societies. Sleep deprivation can cause hormonal changes, such as an increase in cortisol, as well as inflammation. Animal studies have shown an increase in inflammatory cytokine production following sleep deprivation. Additionally, humans experiencing sleep deprivation may experience a decrease in natural killer cells and lymphocytes. Physicians, particularly those in surgical specialties, are often subjected to sleep deprivation as part of their medical residency training. This study hypothesizes that after 24-hour shifts, there is an increase in inflammatory response and impairment of the immune response against unspecific activation. This proposal aims to provide insight into the impact of sleep deprivation on the immune system of surgery residents by characterizing the phenotype and function of immune cells, as well as their correlation with biometric data.

Participants needed: 60
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: University of ChicagoUpdated: Dec 9, 2025Locations: 1
Eligibility criteria

Healthy subjects [+4]

Unwilling/unable to sign informed consent [+1]

Status: Recruiting

Caffeine Optimization Versus Standard Caffeine Dosage (2B-2)

This clinical trial will be a comparison between personalized recommended caffeine dosing regimen versus the standard recommended caffeine dosing regimen for sustaining performance during sleep deprivation and minimizing side effects and subsequent sleep disruption. The questions this study aims to answer are: Whether the personalized caffeine recommendations improve vigilance, sleepiness, and cognition after total sleep deprivation, compared to standard recommendations; Whether the personalized caffeine recommendation better addresses the physical and emotional side effects of total sleep deprivation, compared to standard recommendations; And whether personalized caffeine recommendations aids in better recovery sleep after total sleep deprivation, compared to standard recommendations. Participants will be asked to: 1. Complete a 13-day at-home portion, wearing an actigraph watch to measure activity and sleep, and complete motor vigilance tests up to six times a day. 2. Complete a 4-day in-lab portion, where participants will have to complete one night of baseline sleep, undergo 62-hours of total sleep deprivation, and then complete one night of recovery sleep. 3. During the in-lab portion of the study, participants will be asked to complete more motor vigilance tests. Researchers will be comparing the personalized caffeine recommendation group against the standard caffeine recommendation to see if it is better at addressing each of the main questions.

Participants needed: 180
Trial details
Age: 18-39Biological sex: AllType: InterventionalSponsor: University of ArizonaUpdated: Nov 4, 2025Locations: 2
Eligibility criteria

Age 18-39 years of age [+1]

Self-reported habitual nightly sleep amounts outside the target range of approxi... [+28]

Status: Not yet recruiting

Shift Hours' Impact on Fatigue and Tracking of Eye Dynamics

The goal of this clinical trial is to learn how night shift-induced sleep debt affects oculomotor patterns, attentional state, and diagnostic performance in emergency radiologists. The main questions it aims to answer are: * Does sleep debt from a night shift alter oculomotor parameters, as eyes movements (speed and amplitude), fixation duration, pupil size? * Does a night shift impact radiologists' diagnostic accuracy, attentional state, and perceived fatigue? Researchers will compare radiologists after a night shift (sleep-deprived) with the same radiologists after a night of rest (control) to see if fatigue-related changes affect both visual exploration strategies and diagnostic performance. Participants will: * Perform a guided saccade task assessed by eye tracking (primary endpoint), * Read thoracic CT scans (with and without pulmonary embolism cases) to assess diagnostic performance and visual exploration patterns, * Undergo EEG recording to measure attentional state, * Complete self-report questionnaires on sleepiness and fatigue.

Participants needed: 40
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: IMADIS Technologies et ServicesUpdated: Sep 25, 2025Locations: 1
Eligibility criteria

In their current position for at least one year [+7]

Status: Recruiting

The Peripheral Blood Multi-Omics Study on Sleep Loss

Sleep plays a role in cognitive processes such as memory processing, attention processing, and overall cognitive function. In recent years, the bidirectional relationship between sleep loss and aging, as well as related neurodegenerative diseases, has garnered widespread attention. Sleep disorders are a typical clinical manifestation of neurodegenerative diseases such as Alzheimer's disease (AD) and Parkinson's disease and are closely related to the progression of these diseases. However, current research has yet to fully elucidate the physiological responses to sleep loss across different ages and cognitive levels, as well as the association and molecular basis between sleep loss, aging, and neurodegenerative diseases. This study aims to comprehensively characterize the transcriptional and metabolic changes in peripheral blood under sleep loss in populations of different ages and cognitive levels using multi-omics approaches and to preliminarily explore the role of sleep loss in aging and AD.

Participants needed: 60
Trial details
Age: 18-80Biological sex: AllType: InterventionalSponsor: First Affiliated Hospital of Zhejiang UniversityUpdated: Jul 31, 2025Locations: 1
Eligibility criteria

Signed informed consent form; [+1]

Failure to provide informed consent; [+5]

Status: Not yet recruiting

Impact of Sleep Deprivation on Malnutrition in ICU (Intensive Care Unit) Patients

Study Design This study is a prospective cohort design conducted at Zhongshan Hospital affiliated with Fudan University. It will involve systematic assessments of sleep quality, nutritional status, and associated clinical outcomes in adult ICU patients over a defined observation period. Sample Size: An estimated 150 adult patients (≥18 years) will be recruited from the ICU. Assessments 1. Sleep Quality Assessment: 1. Polysomnography (PSG): Sleep quality and duration will be quantified using PSG, which records brain waves, blood oxygen levels, heart rate, and breathing, as well as eye and leg movements. This will provide a comprehensive picture of sleep architecture and disturbances. 2. Sleep Quality Index: In addition to PSG data, the Pittsburgh Sleep Quality Index (PSQI) will be administered to assess subjective sleep quality, sleep latency, duration, habitual sleep efficiency, sleep disturbances, and daytime dysfunction. 2\. Nutritional Status Evaluation: 1. Nutritional Risk Screening Tools: The Nutritional Risk Screening (NRS-2002) and the Malnutrition Universal Screening Tool (MUST) will be applied to assess nutritional risk and identify malnutrition. 2. Biochemical Assessment: Blood samples will be collected to measure biochemical indicators such as serum albumin, transferrin, prealbumin, and other relevant markers of nutritional status. 3. Anthropometric Measurements: Body mass index (BMI) and muscle mass assessments will be conducted using bioelectrical impedance analysis (BIA) or dual-energy X-ray absorptiometry (DEXA) to quantify body composition. 3\. Physiological Monitoring: 1. Continuous monitoring of vital signs, including heart rate, blood pressure, and respiratory rate, will be performed. 2. Assessment of immune function through laboratory tests, including white blood cell count and levels of inflammatory markers (C-reactive protein). 4\. Complications Tracking: 1\. Data on complications such as infections, delayed wound healing, and respiratory failure will be systematically recorded throughout the ICU stay. This study aims to elucidate the complex interplay between sleep deprivation and malnutrition in ICU patients. By identifying key associations and influencing factors, we hope to inform targeted clinical interventions that can improve patient care, recovery, and quality of life. The findings will serve as a foundation for future research exploring the intricate relationships between sleep and nutritional status in critical care settings.

Participants needed: 150
Trial details
Age: 18-80Biological sex: AllType: ObservationalSponsor: Shanghai Zhongshan HospitalUpdated: Jun 24, 2025
Eligibility criteria

Adult ICU patients (≥18 years) [+2]

Pre-existing malnutrition upon admission (e.g., BMI <18.5 or weight loss >10% wi... [+1]

Status: Recruiting

Transcranial Electrical Stimulation (TES) at Slow Oscillation (SO) Frequency During NREM Sleep

The purpose of this study is to determine if the enhancement of electroencephalographic (EEG) slow-wave activity using transcranial electrical stimulation (TES) at Slow Oscillation (SO) frequency, during a restricted period of nocturnal sleep, enhances the restorative properties of that period of sleep and improves performance during a subsequent period of sleep deprivation.

Participants needed: 40
Trial details
Age: 18-39Biological sex: AllType: InterventionalSponsor: U.S. Army Medical Research and Development CommandUpdated: Jun 13, 2025Locations: 1
Eligibility criteria

Healthy men and non-pregnant, non-lactating women 18 to 39 years of age (inclusi... [+1]

Self-reported habitual nightly sleep amounts outside the target range of 6 - 9 h... [+34]

Status: Not yet recruiting

Evaluating the Efficacy and Safety of PROSOMNIA Sleep Therapy™ in Patients With Sleep Deprivation and Chronic Insomnia

This clinical trial aims to evaluate the safety and efficacy of PROSOMNIA Sleep Therapy (PSTx) for individuals suffering from chronic insomnia, sleep deprivation, and REM sleep disorders. Chronic insomnia, characterized by difficulty falling or staying asleep, significantly affects patients and quality of life, mood, and cognitive function. REM sleep disorders, in which the body struggles to enter or maintain restful REM sleep, can worsen these issues. The trial introduces a novel therapy using anesthesia-induced sleep, targeting sleep homeostasis and improving sleep architecture. Objectives: The primary goals of the trial are to determine: 1. Whether PROSOMNIA Sleep Therapy increases the quality of REM sleep. 2. Whether PSTx increases the duration of REM and/or NREM sleep. 3. Whether PSTx decreases the time it takes participants to fall asleep (sleep onset latency). Participants will receive ONE (1) PROSOMNIA Sleep Therapy session lasting between 60-120 minutes. Each session uses Diprivan/Propofol to induce sleep, and is monitored via an EEG to ensure proper sleep stages, particularly REM sleep. Participant Criteria: Inclusion: Adults aged 18-65 with diagnosed or undiagnosed chronic insomnia or sleep deprivation. Exclusion: Patients with severe obesity, significant cardiovascular, neurological, or psychiatric conditions, or those with an ASA status above II. Study Design: This trial is non-randomized, single-arm and open-label, with all participants receiving the PSTx. The trial does not include a comparison group, as the focus is on evaluating the immediate, direct effects of the therapy. Participants will undergo continuous EEG monitoring during therapy sessions, allowing researchers to track brain activity and sleep stages in real-time. This method ensures that sleep cycles, particularly REM sleep, are optimized for therapeutic benefit. Therapy Methodology: PROSOMNIA Sleep Therapy leverages anesthesia to mimic natural sleep patterns and enhance the efficiency of REM sleep. Diprivan/Propofol is used to induce REM sleep, while EEG monitoring tracks and maintains proper sleep architecture throughout the session. The therapy promotes the clearance of adenosine, a compound that builds up during wakefulness and drives the need for sleep. Adenosine is cleared during REM sleep, reducing sleep pressure and improving cognitive function. Outcome Measures: Primary Outcomes: Researchers will measure the increase in REM sleep duration, improvement in sleep quality (via self-reported questionnaires), and a reduction in sleep onset latency. Secondary Outcomes: These include changes in mood, cognitive function, and blood serum uric acid levels. Patient-reported outcomes will also be tracked through tools like the PROSOMNIA Sleep Quiz, which is specifically designed for PSTx. Significance: Chronic insomnia and REM sleep disorders affect millions globally, leading to cognitive impairment, mood disturbances, and poor overall health. Traditional treatments, including pharmacological approaches and Cognitive Behavioral Therapy for Insomnia (CBT-I), often provide suboptimal results for many individuals. PSTx offers a novel, therapeutic approach to restoring sleep balance and enhancing the overall quality of sleep, particularly for those who have not responded to conventional treatments. Study Process: Recruitment and Baseline Assessments: Participants undergo a comprehensive sleep assessment, including sleep questionnaires and polysomnography, to establish a baseline for sleep quality and duration. Blood serum uric acid levels will also be measured to track any biochemical changes due to therapy. Therapy Sessions: Only one (1) PROSOMNIA Sleep Therapy session will be administered, with the session lasting between 60-120 minutes. Diprivan/Propofol is used to induce sleep, and EEG will monitor brain activity to ensure the proper balance of sleep stages. Post-Therapy Follow-up: Follow-up assessments will occur at 24 hours, 7 days, and 30 days post-treatment. Researchers will analyze the therapy effects on REM sleep, mood, cognitive function, and other health indicators. Potential Implications: If successful, this trial could revolutionize how we treat sleep disorders by targeting the underlying mechanisms of sleep pressure and REM sleep disruption. PROSOMNIA Sleep Therapy may offer a safe, effective, and immediate alternative for patients who have exhausted other treatment options. Key Concepts: Homeostatic sleep drive, (Process S), caused by adenosine buildup during wakefulness, is disrupted by chronic insomnia. This impacts cognitive function health and recovery. Anesthesia-induced REM sleep via PSTx helps regulate this homeostatic sleep stage, offering deeper and more restorative sleep compared to other sleep therapies. The study uses statistical methods like ANOVA and Chi-square to measure outcomes.

Participants needed: 100
Trial details
Phase: Phase 1Age: 18-65Biological sex: AllType: InterventionalSponsor: Nyree PennUpdated: May 28, 2025Locations: 1
Eligibility criteria

Age Range: 18-65 years of age Reason: This age range includes adults who are mos...