Chronic InsomniaPhase 1PSHWNCT06644573
Evaluating the Efficacy and Safety of PROSOMNIA Sleep Therapy™ in Patients With Sleep Deprivation and Chronic Insomnia
A Phase 1 study testing PROSOMNIA Sleep Therapy™ (PSTx), Anesthesia-Induced Sleep Therapy and Diprivan (propofol), Astra-Zeneca in people with Chronic Insomnia and Sleep Deprivation, run by Nyree Penn at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Insomnia, Sleep Deprivation, REM Behavior Disorder
- What is being tested?
- PROSOMNIA Sleep Therapy™ (PSTx), Anesthesia-Induced Sleep Therapy and Diprivan (propofol), Astra-Zeneca
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2025to 1 May 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age Range: 18-65 years of age Reason: This age range includes adults who are most likely to benefit from the PROSOMNIA Sleep therapy and who can provide informed consent. It also excludes children and older adults who may have different physiological responses or additional health risks.
- Diagnosed or Undiagnosed Chronic Insomnia:
- Reason: Included subjects have a consistent pattern of sleep disturbances that PROSOMNIA Sleep Therapy aims to treat.
- 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.
- Diagnosed or Undiagnosed REM Sleep Inconsistencies:
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- 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.
- 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.
- Ability to Provide Informed Consent:
- Reason: Ensures that participants understand the study and agree to participate voluntarily.
Who cannot join
- Severe Obesity (BMI \> 40):
- Reason: Severe obesity can increase the risk of complications with anesthesia and may affect sleep patterns in ways that could confound study results.
- Cardiovascular Conditions:
- Reason: Patients with significant heart conditions are at higher risk for complications during anesthesia.
- Neurological Disorders:
- Reason: These diagnosed conditions and medications such as epilepsy could interfere with sleep patterns and responses to sleep therapy.
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- Other Health Conditions Contraindicating Anesthesia:
- Reason: Includes any condition that would make the use of anesthesia unsafe.
- 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.
- 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.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
PROSOMNIA Sleep Health and Wellness
Aventura, Florida, 33180
Nyree Penn, MHSc., CAA, Master of Health Science, 754-303-2178, Nyree@prosomniasleep.com
David Legros, Medical Doctor- Anesthesia, 216-570-2706, dlegros116@me.com
About this study
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:
Read more
- Whether PROSOMNIA Sleep Therapy increases the quality of REM sleep.
- Whether PSTx increases the duration of REM and/or NREM sleep.
- 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.
Read the detailed description
The clinical trial aims to evaluate the safety and efficacy of PROSOMNIA Sleep Therapy (PSTx), an innovative anesthesia-induced treatment, for patients experiencing chronic insomnia, sleep deprivation, and REM sleep disorders. Chronic insomnia, characterized by persistent difficulty falling or staying asleep, often disrupts sleep homeostasis, affecting cognitive function, mood, and overall quality of life. Conventional treatments, such as Cognitive Behavioral Therapy for Insomnia (CBT-I) and pharmacological interventions, frequently yield suboptimal results, making this trial critical for those unresponsive to standard therapies.
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
- Chronic Insomnia, Sleep Deprivation, REM Behavior Disorder, REM Sleep Behavior Disorder, REM Sleep Measurement, Insomnia
- Being tested
- PROSOMNIA Sleep Therapy™ (PSTx), Anesthesia-Induced Sleep Therapy, Diprivan (propofol), Astra-Zeneca, Continuous EEG Monitoring
- Keywords
- SLEEP, PROSOMNIA Sleep, PROSOMNIA Sleep Therapy, PSTx, PROSOMNIA, Anesthesia Sleep, REM Sleep, REM Sleep Therapy, PROSOMNIA Sleep Health, PROSOMNIA Sleep Wellness, PROSOMNIA Sleep Treatment, Nyree, Nyree Penn, Propofol, Propofol Sleep, Diprivan, Diprivan Sleep, PROSOMNIA Sleep Health and Wellness, Insomnia, Sleep Deprivation
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Sleep Deprivation, REM Sleep Behavior Disorder, Idiopathic Hypersomnia, Sleep Disorders, Circadian Rhythm, Combat Disorders, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROSOMNIA Sleep Therapy™ (PSTx)Procedure or surgery
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 TherapyProcedure or surgery
Also called PROSOMNIA Sleep Therapy, PSTx, PROSOMNIA Sleep
- Single-Arm, Non-Randomized Design: All eligible participants receive the same treatment PROSOMNIA Sleep Therapy(PSTx), ensuring consistency and homogeneity.
- 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.
- 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.
- One (1) Hour PPSTx (60-120 minutes): A PSTx is designed to provide immediate results within a controlled timeframe of 60 to 120 minutes.
- 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.
- Focus on Safety and Feasibility: A single-arm approach allows for a concentrated assessment of treatment efficacy.
Diprivan (propofol), Astra-ZenecaDrug
Also called Propofol
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 MonitoringDevice
Also called SedLine Brain Function Monitoring, MASIMO SedLine EEG, EEG, SedLine
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.
| Study group | Role | What they receive |
|---|---|---|
| Single-Arm - PROSOMNIA Sleep Therapy | Experimental | 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. Receives: Procedure: PROSOMNIA Sleep Therapy™ (PSTx); Procedure: Anesthesia-Induced Sleep Therapy; Drug: Diprivan (propofol), Astra-Zeneca; Device: Continuous EEG Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Homeostatic Sleep Pressure
Evaluate the effectiveness of PROSOMNIA Sleep Therapy in reducing homeostatic sleep pressure, as measured by EEG recordings, blood serum uric acid levels and subjective self-reports.
Measured: 60-120 minutes
Change in Sleep Onset Latency
Measure the time it takes for patients to fall asleep (sleep onset latency) following PROSOMNIA Sleep Therapy, using polysomnography (PSG).
Measured: 30 days
Change in REM Sleep Duration
Measure the improvement in the duration of REM sleep using EEG and polysomnography (PSG) before, during and after PROSOMNIA Sleep Therapy.
Measured: 30 days
Change in Overall Sleep Health
The PROSOMNIA Sleep Quiz (PSQ) is a comprehensive tool used to assess sleep health, specifically for identifying chronic insomnia, REM sleep deprivation, or both. The scale measures sleep quality, quantity, and overall health factors contributing to sleep disorders. The PSQ consists of 18 questions, each scoring various sleep and health-related conditions.
Quiz Scoring System:
Minimum Score: 0 points Maximum Score: 55 points Higher Scores Indicate: Poorer sleep health and worse outcomes.
Measured: 30 days
Secondary outcomes (2)
Changes in Blood Serum Uric Acid Levels
Measure changes in blood serum uric acid levels, reflecting adenosine release into the bloodstream, after PROSOMNIA Sleep Therapy sessions.
Measured: 60-120 minutes
Improvement in Patient-Reported Mood
The Mood Quality Assessment is used to evaluate the impact of PROSOMNIA Sleep Therapy on patient-reported mood following treatment. This assessment utilizes a 5-point scale:
Minimum Value: 1 (Happy) Maximum Value: 5 (Bad) Higher scores indicate worse mood outcomes, reflecting increased mood disturbances or negative emotional states. The assessment is conducted at baseline and post-treatment to gauge changes in mood and emotional well-being, providing insights into the therapy's effect on overall mood regulation and mental health.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start1 Nov 2025 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Chronic InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This clinical trial follows a Single Group Assignment model, where all enrolled participants receive the same intervention-PROSOMNIA Sleep Therapy (PSTx). The model is open-label, meaning both the participants and researchers are aware of the treatment being administered. There is no placebo or control group in this trial, as the focus is to directly evaluate the safety and efficacy of PSTx for chronic insomnia and related REM sleep disorders. 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.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nyree Penn
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Masimo Corporation, PROSOMNIA Sleep Health & Wellness
- Responsible party
- Sponsor-investigator, Nyree Penn, PROSOMNIA Sleep Health & Wellness
- Investigators
- Nyree Penn, MHSc., CAA, Master of Health Science, Principal investigator, Memorial Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06644573
- Sponsor's protocol ID
- PROSOMNIAsleep
- Acronym
- PSHW
- Status last verified
- May 2025
- First submitted
- 8 Sep 2024
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The plan is to share individual participant data (IPD) that underlie the results presented in any forthcoming publications resulting from this trial. This includes all IPD collected and used for analysis and publication, such as de-identified data sets related to primary and secondary outcome measures, baseline characteristics, and adverse event reports. The data will be made available to researchers upon request to promote transparency, reproducibility, and further exploration of the study's findings. Access will be granted in accordance with ethical guidelines and data-sharing policies to ensure participant confidentiality.
Publications
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.
PubMed 12426272Hirotsu 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.
PubMed 23826169Korkutata 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.
PubMed 37741690Lazarus 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.
PubMed 28646346Murdock 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.
PubMed 38418876Nelson 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.
PubMed 15166550Tung 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.
PubMed 15166561Vacas 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.
PubMed 28747855Eleveld 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.
PubMed 29661412Murphy 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.
PubMed 21358845Yang 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.
PubMed 23797824Siegel JM. The neurotransmitters of sleep. J Clin Psychiatry. 2004;65 Suppl 16(Suppl 16):4-7.
PubMed 15575797Vyazovskiy 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.
PubMed 26719733Roth 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.
PubMed 17175184Xu 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.
PubMed 21107748
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy and Safety of PROSOMNIA Sleep Therapy™ in Patients With Sleep Deprivation and Chronic Insomnia
- ClinicalTrials.gov ID
- NCT06644573
- Acronym / sponsor ID
- PSHW / PROSOMNIAsleep
- Conditions
- Chronic Insomnia, Sleep Deprivation, REM Behavior Disorder, REM Sleep Behavior Disorder, REM Sleep Measurement, Insomnia
- Keywords
- SLEEP, PROSOMNIA Sleep, PROSOMNIA Sleep Therapy, PSTx, PROSOMNIA, Anesthesia Sleep, REM Sleep, REM Sleep Therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Nyree PennIndustry (pharma, biotech, devices)
- Collaborators
- Masimo Corporation, PROSOMNIA Sleep Health & Wellness
- Study start
- 1 Nov 2025 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 16 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Whether PROSOMNIA Sleep Therapy increases the quality of REM sleep.
- Whether PSTx increases the duration of REM and/or NREM sleep.
- 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.
Detailed description
The clinical trial aims to evaluate the safety and efficacy of PROSOMNIA Sleep Therapy (PSTx), an innovative anesthesia-induced treatment, for patients experiencing chronic insomnia, sleep deprivation, and REM sleep disorders. Chronic insomnia, characterized by persistent difficulty falling or staying asleep, often disrupts sleep homeostasis, affecting cognitive function, mood, and overall quality of life. Conventional treatments, such as Cognitive Behavioral Therapy for Insomnia (CBT-I) and pharmacological interventions, frequently yield suboptimal results, making this trial critical for those unresponsive to standard therapies.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This clinical trial follows a Single Group Assignment model, where all enrolled participants receive the same intervention-PROSOMNIA Sleep Therapy (PSTx). The model is open-label, meaning both the participants and researchers are aware of the treatment being administered. There is no placebo or control group in this trial, as the focus is to directly evaluate the safety and efficacy of PSTx for chronic insomnia and related REM sleep disorders. 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.
| Arm | Type | Receives |
|---|---|---|
| Single-Arm - PROSOMNIA Sleep Therapy | Experimental | Procedure: PROSOMNIA Sleep Therapy™ (PSTx), Procedure: Anesthesia-Induced Sleep Therapy, Drug: Diprivan (propofol), Astra-Zeneca, Device: Continuous EEG MonitoringDescription: 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age Range: 18-65 years of age Reason: This age range includes adults who are most likely to benefit from the PROSOMNIA Sleep therapy and who can provide informed consent. It also excludes children and older adults who may have different physiological responses or additional health risks.
- Diagnosed or Undiagnosed Chronic Insomnia:
- Reason: Included subjects have a consistent pattern of sleep disturbances that PROSOMNIA Sleep Therapy aims to treat.
- 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.
Key exclusion criteria (14 listed)
- Severe Obesity (BMI \> 40):
- Reason: Severe obesity can increase the risk of complications with anesthesia and may affect sleep patterns in ways that could confound study results.
- Cardiovascular Conditions:
- Reason: Patients with significant heart conditions are at higher risk for complications during anesthesia.
- Neurological Disorders:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Single-Arm - PROSOMNIA Sleep Therapy |
| Anesthesia-Induced Sleep TherapyAlso: PROSOMNIA Sleep Therapy, PSTx, PROSOMNIA Sleep1. 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. | Procedure or surgery | Single-Arm - PROSOMNIA Sleep Therapy |
| Diprivan (propofol), Astra-ZenecaAlso: PropofolDiprivan/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. | Drug | Single-Arm - PROSOMNIA Sleep Therapy |
| Continuous EEG MonitoringAlso: SedLine Brain Function Monitoring, MASIMO SedLine EEG, EEG, SedLineContinuous 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. | Device | Single-Arm - PROSOMNIA Sleep Therapy |
Primary outcome
Reduction in Homeostatic Sleep Pressure
Time frame: 60-120 minutes
Evaluate the effectiveness of PROSOMNIA Sleep Therapy in reducing homeostatic sleep pressure, as measured by EEG recordings, blood serum uric acid levels and subjective self-reports.
Change in Sleep Onset Latency
Time frame: 30 days
Measure the time it takes for patients to fall asleep (sleep onset latency) following PROSOMNIA Sleep Therapy, using polysomnography (PSG).
Change in REM Sleep Duration
Time frame: 30 days
Measure the improvement in the duration of REM sleep using EEG and polysomnography (PSG) before, during and after PROSOMNIA Sleep Therapy.
Change in Overall Sleep Health
Time frame: 30 days
The PROSOMNIA Sleep Quiz (PSQ) is a comprehensive tool used to assess sleep health, specifically for identifying chronic insomnia, REM sleep deprivation, or both. The scale measures sleep quality, quantity, and overall health factors contributing to sleep disorders. The PSQ consists of 18 questions, each scoring various sleep and health-related conditions. Quiz Scoring System: Minimum Score: 0 points Maximum Score: 55 points Higher Scores Indicate: Poorer sleep health and worse outcomes.
2 secondary outcomes
Changes in Blood Serum Uric Acid Levels
Time frame: 60-120 minutes
Improvement in Patient-Reported Mood
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Background: PubMed 12426272Saito 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.
- Background: PubMed 23826169Hirotsu 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.
- Background: PubMed 37741690Korkutata 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.
- Background: PubMed 28646346Lazarus 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.
- Background: PubMed 38418876Murdock 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.
- Background: PubMed 15166550Nelson 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.
- Background: PubMed 15166561Tung 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.
- Background: PubMed 28747855Vacas 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.
- Background: PubMed 29661412Eleveld 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.
- Background: PubMed 21358845Murphy 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.
- Background: PubMed 23797824Yang 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.
- Background: PubMed 15575797Siegel JM. The neurotransmitters of sleep. J Clin Psychiatry. 2004;65 Suppl 16(Suppl 16):4-7.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. The plan is to share individual participant data (IPD) that underlie the results presented in any forthcoming publications resulting from this trial. This includes all IPD collected and used for analysis and publication, such as de-identified data sets related to primary and secondary outcome measures, baseline characteristics, and adverse event reports. The data will be made available to researchers upon request to promote transparency, reproducibility, and further exploration of the study's findings. Access will be granted in accordance with ethical guidelines and data-sharing policies to ensure participant confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nyree Penn, MHSc., CAA, Master of Health Science principal investigator
Memorial Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PROSOMNIA Sleep Therapy™ (PSTx), Anesthesia-Induced Sleep Therapy and Diprivan (propofol), Astra-Zeneca in people with Chronic Insomnia and Sleep Deprivation, run by Nyree Penn at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nyree Penn, MHSc., CAA, Master of Health Science (954-283-0044, trials@prosomniasleep.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in Homeostatic Sleep Pressure (time frame: 60-120 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06644573, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.