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

NCT06644573 | Not Yet Recruiting Phase 1 DMC FDA Drug FDA Device

• 1 other identifier: PROSOMNIAsleep
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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. 1.Whether PROSOMNIA Sleep Therapy increases the quality of REM sleep.
2. 2.Whether PSTx increases the duration of REM and/or NREM sleep.
3. 3.Whether PSTx decreases the time it takes participants to fall asleep (sleep onset latency).

Conditions

Chronic Insomnia; Sleep Deprivation; REM Behavior Disorder; REM Sleep Behavior Disorder; REM Sleep Measurement; Insomnia; Insomnia Related to Specified Disorder; Insomnia Due to Other Mental Disorder; Insomnia Comorbid to Psychiatric Disorder; Insomnia Due to Anxiety and Fear; Insomnia Related to Another Mental Condition; Insomnia Disorders; Idiopathic Hypersomnia; Sleep Disorders, Circadian Rhythm; Post Trauma Nightmares; PTSD - Post Traumatic Stress Disorder; Sleep Quality; Anesthesia; Anxiety; Depression; Mental Health; Alzheimer Disease or Associated Disorder; Parkinsons; Circadian Rhythm; Circadian Dysregulation; PTSD; Post-Traumatic; Post-Traumatic Stress Disorder Complex; Military Combat Stress Reaction; Sleep; Military Activity; Veterans; Shift Work Sleep Disorder; Menopause Related Conditions; Pain; Cancer Pain; Athletes

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; IH; Idiopathic Hypersomnia; Sleep Debt; PTSD; Mental Health; Anxiety; Depression

Outcome Measures

Primary Outcomes (4)

• 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.

  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).

  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.

  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.

  30 days

Secondary Outcomes (2)

• Changes in Blood Serum Uric Acid Levels

  60-120 minutes

• Improvement in Patient-Reported Mood

  30 days

Other Outcomes (2)

• Adverse Event Reporting

  6 months

• PROSOMNIA Sleep Virtual Consultation Note

  30 days

Study Arms (1)

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.

Procedure: PROSOMNIA Sleep Therapy™ (PSTx); Procedure: Anesthesia-Induced Sleep Therapy; Drug: Diprivan (propofol), Astra-Zeneca; Device: Continuous EEG Monitoring

Interventions

PROSOMNIA Sleep Therapy™ (PSTx) PROCEDURE

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.

Single-Arm - PROSOMNIA Sleep Therapy

Anesthesia-Induced Sleep Therapy PROCEDURE

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.

Also known as: PROSOMNIA Sleep Therapy, PSTx, PROSOMNIA Sleep

Single-Arm - PROSOMNIA Sleep Therapy

Diprivan (propofol), Astra-Zeneca DRUG

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.

Also known as: Propofol

Single-Arm - PROSOMNIA Sleep Therapy

Continuous EEG Monitoring DEVICE

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.

Also known as: SedLine Brain Function Monitoring, MASIMO SedLine EEG, EEG, SedLine, MASIMO

Single-Arm - PROSOMNIA Sleep Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Nyree Penn: lead
• Masimo Corporation: collaborator
• PROSOMNIA Sleep Health & Wellness: collaborator

Study Sites (1)

PROSOMNIA Sleep Health and Wellness

Aventura, Florida, 33180, United States

Location

Related Publications (15)

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• 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.

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• 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.

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  PMID: 38418876 BACKGROUND

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• 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.

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• 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.

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  PMID: 21107748 BACKGROUND

Related Links

• 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.

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Sleep Deprivation; REM Sleep Behavior Disorder; Idiopathic Hypersomnia; Sleep Disorders, Circadian Rhythm; Combat Disorders; Anxiety Disorders; Depression; Psychological Well-Being; Alzheimer Disease; Chronobiology Disorders; Stress Disorders, Post-Traumatic; Pain; Cancer Pain

Interventions

Propofol; Electroencephalography

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; REM Sleep Parasomnias; Parasomnias; Disorders of Excessive Somnolence; Occupational Diseases; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Behavioral Symptoms; Behavior; Personal Satisfaction; Dementia; Brain Diseases; Central Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Officials

• Nyree Penn, MHSc., CAA, Master of Health Science

  Memorial Healthcare System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nyree Penn, MHSc., CAA, Master of Health Science

CONTACT

954-283-0044; trials@prosomniasleep.com

David Legros, MD, Medical Doctor- Anesthesia

CONTACT

954-283-0044; Dlegros116@me.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MHSc., CEO

Model Details: 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.

Study Record Dates

• First Submitted: September 8, 2024
• First Posted: October 16, 2024
• Study Start: November 1, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The individual participant data (IPD) and supporting information will be available starting 6 months after the publication of the primary study results. The data will remain accessible for 5 years following the initial release. After this period, access may be reviewed and extended upon request.
• Access Criteria: The individual participant data (IPD) and supporting information will be accessible to qualified researchers affiliated with academic institutions, healthcare organizations, or industry partners involved in sleep medicine research. Researchers must submit a detailed research proposal outlining the purpose and objectives of their study. Access will be granted following approval by an independent review board to ensure the scientific merit and ethical use of the data. Researchers will be required to sign a data use agreement (DUA) to maintain confidentiality and adhere to ethical guidelines. Data will be shared through a secure online platform.

Locations

US (1)