Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06644573 | Evaluating the Efficacy and Safety of PROSOMNIA Sleep Therapy™ in Patients With Sleep Deprivation and Chronic Insomnia | PHASE1 | NOT YET_RECRUITING | 100 | — | — | Nov 1, 2025 | May 1, 2026 | May 28, 2025 | 1 | United States |
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.
Measure the time it takes for patients to fall asleep (sleep onset latency) following PROSOMNIA Sleep Therapy, using polysomnography (PSG).
Measure the improvement in the duration of REM sleep using EEG and polysomnography (PSG) before, during and after PROSOMNIA Sleep Therapy.
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.
| Arm | Type | Description |
|---|---|---|
| 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. |
| Name | Type | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
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 a...