Study: NCT06644573

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: PROSOMNIA Sleep Therapy™ (PSTx)
Description: 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.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Anesthesia-Induced Sleep Therapy
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Diprivan (propofol), Astra-Zeneca
Description: 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.

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Continuous EEG Monitoring
Description: 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.