Evaluating the Efficacy and Safety of PROSOMNIA Sleep Therapy™ in Patients With Sleep Deprivation and Chronic Insomnia
Not yet recruitingPhase 1NCT06644573
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
This clinical trial aims to evaluate the safety and efficacy of PROSOMNIA Sleep Therapy (PSTx) for individuals suffering from chronic insomnia, sleep deprivation, and REM sleep disorders. Chronic insomnia, characterized by difficulty falling or staying asleep, significantly affects patients and quality of life, mood, and cognitive function. REM sleep disorders, in which the body struggles to enter or maintain restful REM sleep, can worsen these issues. The trial introduces a novel therapy using anesthesia-induced sleep, targeting sleep homeostasis and improving sleep architecture. Objectives: The primary goals of the trial are to determine: 1. Whether PROSOMNIA Sleep Therapy increases the quality of REM sleep. 2. Whether PSTx increases the duration of REM and/or NREM sleep. 3. Whether PSTx decreases the time it takes participants to fall asleep (sleep onset latency). Participants will receive ONE (1) PROSOMNIA Sleep Therapy session lasting between 60-120 minutes. Each session uses Diprivan/Propofol to induce sleep, and is monitored via an EEG to ensure proper sleep stages, particularly REM sleep. Participant Criteria: Inclusion: Adults aged 18-65 with diagnosed or undiagnosed chronic insomnia or sleep deprivation. Exclusion: Patients with severe obesity, significant cardiovascular, neurological, or psychiatric conditions, or those with an ASA status above II. Study Design: This trial is non-randomized, single-arm and open-label, with all participants receiving the PSTx. The trial does not include a comparison group, as the focus is on evaluating the immediate, direct effects of the therapy. Participants will undergo continuous EEG monitoring during therapy sessions, allowing researchers to track brain activity and sleep stages in real-time. This method ensures that sleep cycles, particularly REM sleep, are optimized for therapeutic benefit. Therapy Methodology: PROSOMNIA Sleep Therapy leverages anesthesia to mimic natural sleep patterns and enhance the efficiency of…
Study details
- Official title
- Evaluating the Efficacy and Safety of PROSOMNIA Sleep Therapy™ in Patients With Sleep Deprivation and Chronic Insomnia
- 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
- Interventions
- Procedure: PROSOMNIA Sleep Therapy™ (PSTx)
- Procedure: Anesthesia-Induced Sleep Therapy
- Drug: Diprivan (propofol), Astra-Zeneca
- Device: Continuous EEG Monitoring
- Sponsor
- Nyree Penn
- Collaborators
- Masimo Corporation; PROSOMNIA Sleep Health & Wellness
- Organization
- PROSOMNIA Sleep Health & Wellness
- Start date
- 2025-11-01
- Primary completion
- 2026-05-01
- Sex
- All
- Age range
- from 18 Years to 65 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
By adhering to the following criteria, the study aims to select a population that can safely undergo the PROSOMNIA Sleep therapy and for whom the therapy is most likely to be beneficial, ensuring the reliability and validity of the study outcomes. INCLUSION CRITERIA: 1. 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. 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: 1. 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. 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: Re…
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06644573