PROSOMNIA Sleep Therapy for Chronic Insomnia

(PSHW Trial)

This trial tests a new therapy, PROSOMNIA Sleep Therapy™ (PSTx), designed to improve sleep for those with chronic insomnia and REM sleep issues. The therapy uses anesthesia to induce sleep, aiming to enhance the quality and duration of REM sleep. Participants will undergo one session with close monitoring to ensure improved sleep patterns. The trial seeks adults who struggle with insomnia or sleep deprivation and have not found relief with other treatments. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

Yes, you will need to stop taking certain medications, specifically sedatives and hypnotics like benzodiazepines, Z-drugs, and barbiturates, as they could interfere with the anesthesia used in the therapy.

Research has shown that Diprivan/Propofol, the anesthesia used in PROSOMNIA Sleep Therapy, is generally safe and effective for aiding sleep onset. The FDA has already approved this drug for other medical uses, confirming its safety in humans. In this early stage of testing for sleep disorders, the researchers are focusing on its safety and effectiveness specifically for improving sleep in individuals with chronic insomnia. During therapy, real-time EEG monitoring checks brain activity to ensure balanced sleep stages, aiming to safely enhance the quality of REM sleep.¹²³⁴⁵

Unlike the standard treatments for chronic insomnia, which often include medications like benzodiazepines or cognitive behavioral therapy, PROSOMNIA Sleep Therapy (PSTx) uses a unique approach by inducing sleep through a controlled, anesthesia-induced session with Diprivan/Propofol. This method allows researchers to directly influence sleep stages and track brain activity in real-time with EEG monitoring. Researchers are excited about this treatment because it targets sleep architecture directly, offering a new way to improve sleep quality and reduce insomnia symptoms more rapidly than traditional therapies.

Research shows that PROSOMNIA Sleep Therapy (PSTx), administered in this trial, aims to help individuals with chronic insomnia by using anesthesia to improve sleep patterns. The therapy employs Diprivan/Propofol to induce sleep, potentially increasing the length and quality of REM sleep. REM sleep plays a crucial role in clearing adenosine, a chemical that causes tiredness. By enhancing REM sleep, PSTx may help individuals fall asleep faster and improve overall sleep quality. Although human studies provide limited data, this approach targets known sleep processes, suggesting effectiveness for those who have not succeeded with regular sleep therapies.²³⁴⁵⁶