PROSOMNIA Sleep Therapy for Chronic Insomnia

(PSHW Trial)

Not yet recruiting at 1 trial location

Overseen By David Legros, MD, Medical Doctor- Anesthesia

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Nyree Penn

Must not be taking: Sedatives, Hypnotics

Disqualifiers: Severe obesity, Cardiovascular, Neurological, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this 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.

Will I have to stop taking my current medications?

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.

What prior data suggests that PROSOMNIA Sleep Therapy is safe for individuals with chronic insomnia?

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. ^{1 2 3 4 5}

Why are researchers excited about this trial?

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.

What evidence suggests that PROSOMNIA Sleep Therapy might be an effective treatment for chronic insomnia?

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. ^{2 3 4 5 6}

Who Is on the Research Team?

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

Principal Investigator

Memorial Healthcare System

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 who struggle with chronic insomnia or sleep deprivation. It's not suitable for those with severe obesity, major heart, brain, or mental health issues, or an ASA status above II (indicating serious health risks).

Inclusion Criteria

I have issues with my sleep quality or REM sleep phase.

I am not getting enough sleep.

I have trouble sleeping regularly, diagnosed or not.

Exclusion Criteria

I have a serious heart condition.

Greater than ASA II Status - Excluding those above ASA II ensures that only patients with mild systemic disease are included, to minimize risks.

I am not pregnant or breastfeeding.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Comprehensive sleep assessment including sleep questionnaires and polysomnography to establish baseline sleep quality and duration

1 week

1 visit (in-person)

Treatment

Participants receive one PROSOMNIA Sleep Therapy session lasting 60-120 minutes, using Diprivan/Propofol to induce sleep with continuous EEG monitoring

1 day

1 visit (in-person)

Post-Therapy Follow-up

Follow-up assessments to evaluate therapy effects on REM sleep, mood, cognitive function, and other health indicators

30 days

3 visits (in-person or virtual) at 24 hours, 7 days, and 30 days post-treatment

What Are the Treatments Tested in This Trial?

Interventions

• PROSOMNIA Sleep Therapy™ (PSTx)

Trial Overview The trial tests PROSOMNIA Sleep Therapy™ using anesthesia-induced sleep to improve REM and NREM sleep quality in people with chronic insomnia. Participants will have one session monitored by EEG to track the effects on their sleep stages.

How Is the Trial Designed?

Group I: Single-Arm - PROSOMNIA Sleep Therapy Experimental Treatment 4 Interventions

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.

Who Is Running the Clinical Trial?

Nyree Penn

Lead Sponsor

Trials

1

Recruited

100+

Masimo Corporation

Industry Sponsor

Trials

117

Recruited

13,500+

Katie Szyman

Masimo Corporation

Chief Executive Officer

BA from the University of St. Thomas, MBA from Harvard Business School

Dr. Bilal Muhsin

Masimo Corporation

Chief Medical Officer since 2024

MD from Harvard Medical School

PROSOMNIA Sleep Health & Wellness

Industry Sponsor

Trials

1

Recruited

100+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06644573

Evaluating the Efficacy and Safety of PROSOMNIA Sleep ... This trial aims to demonstrate that PROSOMNIA Sleep Therapy can effectively restore sleep homeostasis and improve REM sleep quality, providing a new avenue for ...

2. ctv.veeva.com ctv.veeva.com/study/evaluating-the-efficacy-and-safety-of-prosomnia-sleep-therapy-in-patients-with-sleep-deprivation-an

Evaluating the Efficacy and Safety of PROSOMNIA Sleep ... This trial aims to demonstrate that PROSOMNIA Sleep Therapy can effectively restore sleep homeostasis and improve REM sleep quality, providing a ...

3. cdek.pharmacy.purdue.edu cdek.pharmacy.purdue.edu/trial/NCT06644573/

Trial | NCT06644573 Conclusion: This trial aims to demonstrate that PROSOMNIA Sleep Therapy can effectively restore sleep homeostasis and improve REM sleep quality, providing a ...

4. withpower.com withpower.com/trial/phase-1-alzheimer-disease-10-2024-b348d

PROSOMNIA Sleep Therapy for Chronic Insomnia (PSHW ... This clinical trial aims to evaluate the safety and efficacy of PROSOMNIA Sleep Therapy (PSTx) for individuals suffering from chronic insomnia, sleep ...

5. smartpatients.com smartpatients.com/trials/NCT06644573

Evaluating the Efficacy and Safety of PROSOMNIA Sleep ... Primary Outcomes: Researchers will measure the increase in REM sleep duration, improvement in sleep quality (via self-reported questionnaires), and a reduction ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06644573?term=prosomnia&rank=1

Evaluating the Efficacy and Safety of PROSOMNIA Sleep ... This clinical trial aims to evaluate the safety and efficacy of PROSOMNIA Sleep Therapy (PSTx) for individuals suffering from chronic insomnia, sleep ...