Evaluating the Efficacy and Safety of PROSOMNIA Sleep Therapy™ in Patients With Sleep Deprivation and Chronic Insomnia
NCT ID: NCT06644573
Last Updated: 2025-05-28
Study Results
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Basic Information
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NOT_YET_RECRUITING
PHASE1
100 participants
INTERVENTIONAL
2025-11-01
2026-05-01
Brief Summary
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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.
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Detailed Description
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Mechanism and Methodology:
PROSOMNIA Sleep Therapy uses a novel approach to target the homeostatic sleep drive by leveraging Diprivan/Propofol, an anesthetic that acts on GABA\_A receptors to induce and maintain REM sleep. This process addresses sleep pressure caused by adenosine buildup during wakefulness, promoting its clearance during REM sleep. This controlled anesthesia-induced therapy aims to restore disrupted sleep homeostasis and optimize REM sleep architecture.
During the session, Diprivan/Propofol is administered under Monitored Anesthesia Care (MAC), with continuous EEG monitoring to ensure that sleep stages are appropriately maintained. The single-session therapy, lasting 60-120 minutes, not only aims to enhance REM sleep but also to reduce sleep onset latency (the time required to fall asleep) and improve overall sleep quality.
Study Objectives:
The primary objectives are to determine if PSTx increases REM sleep duration, reduces sleep onset latency, and improves overall sleep quality. Secondary objectives include assessing changes in mood, cognitive function, and biochemical markers (e.g., blood serum uric acid levels).
Broader Implications:
PROSOMNIA Sleep Therapy's innovative method could have broader applications beyond insomnia, including treating mental health disorders (e.g., depression, PTSD), neurodegenerative diseases (e.g., Alzheimer's), and enhancing cardiovascular and metabolic health. Athletes or individuals recovering from injury may also benefit from improved sleep quality and recovery.
Study Design:
This is a non-randomized, single-arm, open-label trial with all participants receiving PSTx to directly observe therapeutic effects without a comparison group. The design allows for focused assessment of therapy outcomes in patients unresponsive to conventional treatments.
Participant Criteria:
Inclusion: Adults aged 18-65 with diagnosed or undiagnosed chronic insomnia or sleep deprivation, with or without prior therapy.
Exclusion: Severe obesity (BMI \>35), cardiovascular, neurological, or psychiatric conditions that contraindicate anesthesia, ASA status above II, or diagnosed sleep disorders unrelated to insomnia.
Outcome Measures:
Primary Outcomes: Increased total REM sleep duration (via EEG), improved overall sleep quality (measured by validated questionnaires), and reduced sleep onset latency.
Secondary Outcomes: Changes in cognitive function, mood, and blood serum uric acid levels, tracked through questionnaires and laboratory analyses.
Study Process:
Participants will undergo a comprehensive sleep assessment using polysomnography (PSG) and sleep questionnaires to establish baseline sleep patterns. During the therapy session, Diprivan/Propofol will be administered under anesthesia care, with continuous EEG monitoring to optimize sleep stages. Follow-up assessments at 24 hours, 7 days, and 30 days post-therapy will evaluate changes in REM sleep, mood, cognitive function, and overall health.
Potential Impact:
If successful, this study could position PROSOMNIA Sleep Therapy as a rapid and effective alternative to traditional insomnia treatments, offering hope for individuals unresponsive to current therapies. The study will provide new insights into adenosine clearance, REM sleep regulation, and their roles in cognitive recovery and mood stabilization.
Statistical Analysis:
Primary and Secondary Outcomes: Changes in continuous variables (e.g., REM sleep duration, sleep latency, uric acid levels) will be analyzed using Paired t-tests and ANOVA. Categorical outcomes (e.g., adverse events) will be analyzed using Chi-square tests. Non-normally distributed variables will be evaluated using the Wilcoxon Signed-Rank Test.
Predictive Analysis: Logistic regression will identify baseline variables that predict therapeutic outcomes.
Conclusion:
This trial aims to demonstrate that PROSOMNIA Sleep Therapy can effectively restore sleep homeostasis and improve REM sleep quality, providing a new avenue for treating chronic insomnia and associated conditions. The results could revolutionize the treatment landscape for sleep disorders, particularly in patients who have not found relief with existing options.
The findings will contribute significantly to the field of sleep medicine and open doors for further research in diverse clinical populations, improving sleep health and overall well-being.
Conditions
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Study Design
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NA
SINGLE_GROUP
The intervention involves the use of monitored anesthesia care (MAC) to induce and regulate REM sleep, using Diprivan/Propofol under the supervision of an Anesthesiologist and a Certified Anesthetist. Continuous EEG monitoring ensures proper sleep architecture is achieved during the therapy session, and adjustments are made in real-time to optimize therapeutic outcomes.
TREATMENT
NONE
Study Groups
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Single-Arm - PROSOMNIA Sleep Therapy
Description: All eligible participants in this study will be assigned to a single arm and receive the same intervention, PROSOMNIA Sleep Therapy. This involves a controlled, anesthesia-induced sleep session using Diprivan/Propofol, administered under the supervision of an Anesthesiologist. Monitoring will include American Society of Anesthesiologists (ASA) standard monitoring and real-time EEG to track sleep stages and brain activity during the procedure.
Interventions: PROSOMNIA Sleep Therapy, involving the administration of Diprivan/Propofol, a FDA-approved anesthetic, to induce sleep in individuals with chronic insomnia, sleep deprivation and/or REM sleep disparities. This treatment is intended to reduce sleep pressure, decrease sleep onset latency, enhance REM sleep duration, and improve overall sleep quality. Continuous EEG monitoring to track sleep architecture and blood serum uric acid tests to identify adenosine release.
PROSOMNIA Sleep Therapy™ (PSTx)
PROSOMNIA Sleep Therapy (PSTx) is a novel intervention designed to manage homeostatic sleep pressure by leveraging an anesthesia-induced protocol. Using Diprivan/Propofol, PSTx rapidly induces REM sleep, clearing adenosine from the brain and reducing sleep pressure more efficiently than traditional methods. Monitored in real-time via EEG, this therapy personalizes sleep architecture optimization, ensuring deep restorative REM sleep. PSTx stands apart as a promising treatment for chronic insomnia, sleep deprivation, and REM sleep disorders, offering long-term improvement in sleep quality and overall health.
Anesthesia-Induced Sleep Therapy
1. Single-Arm, Non-Randomized Design: All eligible participants receive the same treatment PROSOMNIA Sleep Therapy(PSTx), ensuring consistency and homogeneity.
2. Targeted Use of Diprivan/Propofol: The PSTx involves the administration of Diprivan/Propofol, an FDA-approved anesthetic, delivered in a controlled environment under the supervision of an Anesthesiologist.
3. Monitored Anesthesia with Advanced Sleep Assessment: The procedure is monitored according to ASA (American Society of Anesthesiologists) standards, along with real-time EEG to track brain activity during REM sleep.
4. One (1) Hour PPSTx (60-120 minutes): A PSTx is designed to provide immediate results within a controlled timeframe of 60 to 120 minutes.
5. Follow-Up Protocol: Post-treatment follow-ups occur at 24 hours, 7 days, and 30 days after the session to measure outcomes and safety parameters.
6. Focus on Safety and Feasibility: A single-arm approach allows for a concentrated assessment of treatment efficacy.
Diprivan (propofol), Astra-Zeneca
Diprivan/Propofol is a short-acting intravenous anesthetic used in PROSOMNIA Sleep Therapy to induce rapid and controlled REM sleep. Unlike other sleep aids, Propofol works by potentiating GABA\_A receptor activity, leading to a deeper and faster transition into sleep. The administration is closely monitored in real-time using EEG to ensure optimal sleep stages are achieved. Propofol is distinct from traditional sedatives due to its precise control, rapid onset, and ability to clear adenosine from the brain, reducing sleep pressure effectively and safely.
Continuous EEG Monitoring
Continuous EEG Monitoring is an essential component of PROSOMNIA Sleep Therapy, used to accurately track and optimize sleep architecture in real time. This device provides precise monitoring of brainwave activity, ensuring the patient achieves the necessary stages of REM sleep during therapy. Unlike other monitoring systems, this EEG is used to dynamically adjust the Diprivan/Propofol infusion, allowing for personalized sleep regulation. The continuous data collection helps maintain ideal sleep conditions, distinguishing it from standard sleep therapy interventions that lack real-time neurological insights.
Interventions
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PROSOMNIA Sleep Therapy™ (PSTx)
PROSOMNIA Sleep Therapy (PSTx) is a novel intervention designed to manage homeostatic sleep pressure by leveraging an anesthesia-induced protocol. Using Diprivan/Propofol, PSTx rapidly induces REM sleep, clearing adenosine from the brain and reducing sleep pressure more efficiently than traditional methods. Monitored in real-time via EEG, this therapy personalizes sleep architecture optimization, ensuring deep restorative REM sleep. PSTx stands apart as a promising treatment for chronic insomnia, sleep deprivation, and REM sleep disorders, offering long-term improvement in sleep quality and overall health.
Anesthesia-Induced Sleep Therapy
1. Single-Arm, Non-Randomized Design: All eligible participants receive the same treatment PROSOMNIA Sleep Therapy(PSTx), ensuring consistency and homogeneity.
2. Targeted Use of Diprivan/Propofol: The PSTx involves the administration of Diprivan/Propofol, an FDA-approved anesthetic, delivered in a controlled environment under the supervision of an Anesthesiologist.
3. Monitored Anesthesia with Advanced Sleep Assessment: The procedure is monitored according to ASA (American Society of Anesthesiologists) standards, along with real-time EEG to track brain activity during REM sleep.
4. One (1) Hour PPSTx (60-120 minutes): A PSTx is designed to provide immediate results within a controlled timeframe of 60 to 120 minutes.
5. Follow-Up Protocol: Post-treatment follow-ups occur at 24 hours, 7 days, and 30 days after the session to measure outcomes and safety parameters.
6. Focus on Safety and Feasibility: A single-arm approach allows for a concentrated assessment of treatment efficacy.
Diprivan (propofol), Astra-Zeneca
Diprivan/Propofol is a short-acting intravenous anesthetic used in PROSOMNIA Sleep Therapy to induce rapid and controlled REM sleep. Unlike other sleep aids, Propofol works by potentiating GABA\_A receptor activity, leading to a deeper and faster transition into sleep. The administration is closely monitored in real-time using EEG to ensure optimal sleep stages are achieved. Propofol is distinct from traditional sedatives due to its precise control, rapid onset, and ability to clear adenosine from the brain, reducing sleep pressure effectively and safely.
Continuous EEG Monitoring
Continuous EEG Monitoring is an essential component of PROSOMNIA Sleep Therapy, used to accurately track and optimize sleep architecture in real time. This device provides precise monitoring of brainwave activity, ensuring the patient achieves the necessary stages of REM sleep during therapy. Unlike other monitoring systems, this EEG is used to dynamically adjust the Diprivan/Propofol infusion, allowing for personalized sleep regulation. The continuous data collection helps maintain ideal sleep conditions, distinguishing it from standard sleep therapy interventions that lack real-time neurological insights.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Diagnosed or Undiagnosed Chronic Insomnia:
Reason: Included subjects have a consistent pattern of sleep disturbances that PROSOMNIA Sleep Therapy aims to treat.
3. Diagnosed or Undiagnosed Sleep Deprivation:
Reason: Includes individuals who are not getting enough sleep quantity, which is a key condition that the PROSOMNIA Sleep Therapy aims to address.
4. Diagnosed or Undiagnosed REM Sleep Inconsistencies:
Reason: Includes individuals who are not getting enough sleep quality and those with specific REM sleep phase issues that the PROSOMNIA Sleep Therapy is designed to improve.
5. Failure to Respond to Conventional Sleep Treatments:
Reason: Focuses on subjects who have not found relief from existing sleep therapies, ensuring that the study population represents those in need of alternative solutions.
6. Ability to Provide Informed Consent:
Reason: Ensures that participants understand the study and agree to participate voluntarily.
Exclusion Criteria
Reason: Severe obesity can increase the risk of complications with anesthesia and may affect sleep patterns in ways that could confound study results.
2. Cardiovascular Conditions:
Reason: Patients with significant heart conditions are at higher risk for complications during anesthesia.
3. Neurological Disorders:
Reason: These diagnosed conditions and medications such as epilepsy could interfere with sleep patterns and responses to sleep therapy.
4. Other Health Conditions Contraindicating Anesthesia:
Reason: Includes any condition that would make the use of anesthesia unsafe.
5. Greater than ASA II Status:
Reason: The American Society of Anesthesiologists (ASA) physical status classification system classifies patients based on their pre-anesthesia medical conditions. Excluding those above ASA II ensures that only patients with mild systemic disease are included, to minimize risks.
6. Current Use of Prohibited Medications:
Reason: Medications that could interfere with the combined use of anesthesia including, but not limited to sedatives and hypnotics; such as benzodiazepines, Z-drugs and barbiturates.
7. Pregnancy or Breastfeeding:
Reason: Ensures the safety of the fetus or infant, as the effects of the PROSOMNIA Sleep therapy on pregnancy or lactation are unknown.
18 Years
65 Years
ALL
Yes
Sponsors
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Masimo Corporation
INDUSTRY
PROSOMNIA Sleep Health & Wellness
INDUSTRY
Nyree Penn
INDUSTRY
Responsible Party
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Nyree Penn
MHSc., CEO
Principal Investigators
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Nyree Penn, MHSc., CAA, Master of Health Science
Role: PRINCIPAL_INVESTIGATOR
Memorial Healthcare System
Locations
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PROSOMNIA Sleep Health and Wellness
Aventura, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Saito H, Nishimura M, Shibuya E, Makita H, Tsujino I, Miyamoto K, Kawakami Y. Tissue hypoxia in sleep apnea syndrome assessed by uric acid and adenosine. Chest. 2002 Nov;122(5):1686-94. doi: 10.1378/chest.122.5.1686.
Hirotsu C, Tufik S, Guindalini C, Mazzotti DR, Bittencourt LR, Andersen ML. Association between uric acid levels and obstructive sleep apnea syndrome in a large epidemiological sample. PLoS One. 2013 Jun 24;8(6):e66891. doi: 10.1371/journal.pone.0066891. Print 2013.
Korkutata M, Lazarus M. Adenosine A2A receptors and sleep. Int Rev Neurobiol. 2023;170:155-178. doi: 10.1016/bs.irn.2023.04.007. Epub 2023 Apr 29.
Lazarus M, Chen JF, Huang ZL, Urade Y, Fredholm BB. Adenosine and Sleep. Handb Exp Pharmacol. 2019;253:359-381. doi: 10.1007/164_2017_36.
Murdock MH, Yang CY, Sun N, Pao PC, Blanco-Duque C, Kahn MC, Kim T, Lavoie NS, Victor MB, Islam MR, Galiana F, Leary N, Wang S, Bubnys A, Ma E, Akay LA, Sneve M, Qian Y, Lai C, McCarthy MM, Kopell N, Kellis M, Piatkevich KD, Boyden ES, Tsai LH. Multisensory gamma stimulation promotes glymphatic clearance of amyloid. Nature. 2024 Mar;627(8002):149-156. doi: 10.1038/s41586-024-07132-6. Epub 2024 Feb 28.
Nelson LE, Franks NP, Maze M. Rested and refreshed after anesthesia? Overlapping neurobiologic mechanisms of sleep and anesthesia. Anesthesiology. 2004 Jun;100(6):1341-2. doi: 10.1097/00000542-200406000-00003. No abstract available.
Tung A, Bergmann BM, Herrera S, Cao D, Mendelson WB. Recovery from sleep deprivation occurs during propofol anesthesia. Anesthesiology. 2004 Jun;100(6):1419-26. doi: 10.1097/00000542-200406000-00014.
Vacas S, Kurien P, Maze M. Sleep and Anesthesia - Common mechanisms of action. Sleep Med Clin. 2013 Mar;8(1):1-9. doi: 10.1016/j.jsmc.2012.11.009. No abstract available.
Eleveld DJ, Colin P, Absalom AR, Struys MMRF. Pharmacokinetic-pharmacodynamic model for propofol for broad application in anaesthesia and sedation. Br J Anaesth. 2018 May;120(5):942-959. doi: 10.1016/j.bja.2018.01.018. Epub 2018 Mar 12.
Murphy M, Bruno MA, Riedner BA, Boveroux P, Noirhomme Q, Landsness EC, Brichant JF, Phillips C, Massimini M, Laureys S, Tononi G, Boly M. Propofol anesthesia and sleep: a high-density EEG study. Sleep. 2011 Mar 1;34(3):283-91A. doi: 10.1093/sleep/34.3.283.
Yang CM, Lin SC, Cheng CP. Transient insomnia versus chronic insomnia: a comparison study of sleep-related psychological/behavioral characteristics. J Clin Psychol. 2013 Oct;69(10):1094-107. doi: 10.1002/jclp.22000. Epub 2013 Jun 24.
Siegel JM. The neurotransmitters of sleep. J Clin Psychiatry. 2004;65 Suppl 16(Suppl 16):4-7.
Vyazovskiy VV. Sleep, recovery, and metaregulation: explaining the benefits of sleep. Nat Sci Sleep. 2015 Dec 17;7:171-84. doi: 10.2147/NSS.S54036. eCollection 2015.
Roth T, Roehrs T, Pies R. Insomnia: pathophysiology and implications for treatment. Sleep Med Rev. 2007 Feb;11(1):71-9. doi: 10.1016/j.smrv.2006.06.002. Epub 2006 Dec 18.
Xu Z, Jiang X, Li W, Gao D, Li X, Liu J. Propofol-induced sleep: efficacy and safety in patients with refractory chronic primary insomnia. Cell Biochem Biophys. 2011 Jul;60(3):161-6. doi: 10.1007/s12013-010-9135-7.
Study Documents
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Document Type: Statistical Analysis Plan
Study Protocol and Statistical Analysis Plan (SAP)
View DocumentRelated Links
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Welcome to the PROSOMNIA Sleep Clinical Trials information page! Here, potential participants can learn more about our innovative clinical research dedicated to advancing sleep health and wellness
PROSOMNIA Sleep Health \& Wellness is dedicated to revolutionizing sleep health through innovative therapies and solutions. The website provides information on cutting-edge sleep therapies, including anesthesia-induced treatments.
Other Identifiers
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PROSOMNIAsleep
Identifier Type: -
Identifier Source: org_study_id
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