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Behavioural Intervention

PROSOMNIA Sleep Therapy for Chronic Insomnia (PSHW Trial)

Phase 1

Waitlist Available

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

Research Sponsored by Nyree Penn

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age Range: 18-65 years of age - 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.

Be older than 18 years old

Must not have

Current Use of Prohibited Medications - Medications that could interfere with the combined use of anesthesia including, but not limited to sedatives and hypnotics; such as benzodiazepines, Z-drugs and barbiturates.

Pregnancy or Breastfeeding - Ensures the safety of the fetus or infant, as the effects of the PROSOMNIA Sleep therapy on pregnancy or lactation are unknown.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test a new therapy called PROSOMNIA Sleep Therapy (PSTx) for people with chronic insomnia and REM sleep disorders. The therapy uses anesthesia to improve the quality and

Who is the study for?

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).

What is being tested?

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.

What are the potential side effects?

Potential side effects may include reactions to anesthesia such as grogginess, nausea, headache, or dizziness. Continuous monitoring during the therapy aims to minimize risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not currently taking any medications that could interfere with anesthesia, like sedatives.

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I am not pregnant or breastfeeding.

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I do not have health conditions that make anesthesia unsafe for me.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Overall Sleep Health

Change in REM Sleep Duration

Change in Sleep Onset Latency

+1 more

Secondary study objectives

Changes in Blood Serum Uric Acid Levels

Improvement in Patient-Reported Mood

Other study objectives

Adverse Event Reporting

PROSOMNIA Sleep Virtual Consultation Note

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Single-Arm - PROSOMNIA Sleep TherapyExperimental Treatment4 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Diprivan (propofol), Astra-Zeneca

2007

Completed Phase 4

~80

0 / 4Eligibility criteria met