Clinical trial NCT06644573: Evaluating the Efficacy and Safety of PROSOMNIA Sleep Therapy™ in Patients With Sleep Deprivation and Chronic Insomnia
Official title: Evaluating the Efficacy and Safety of PROSOMNIA Sleep Therapy™ in Patients With Sleep Deprivation and Chronic Insomnia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Chronic Insomnia
Sleep Deprivation
REM Behavior Disorder
REM Sleep Behavior Disorder
REM Sleep Measurement
Insomnia
Insomnia Related to Specified Disorder
Insomnia Due to Other Mental Disorder
Insomnia Comorbid to Psychiatric Disorder
Insomnia Due to Anxiety and Fear
Insomnia Related to Another Mental Condition
Insomnia Disorders
Idiopathic Hypersomnia
Sleep Disorders, Circadian Rhythm
Post Trauma Nightmares
PTSD - Post Traumatic Stress Disorder
Sleep Quality
Anesthesia
Anxiety
Depression
Mental Health
Alzheimer Disease or Associated Disorder
Parkinsons
Circadian Rhythm
Circadian Dysregulation
PTSD
Post-Traumatic
Post-Traumatic Stress Disorder Complex
Military Combat Stress Reaction
Sleep
Military Activity
Veterans
Shift Work Sleep Disorder
Menopause Related Conditions
Pain
Cancer Pain
Athletes
Keywords: SLEEP
PROSOMNIA Sleep
PROSOMNIA Sleep Therapy
PSTx
PROSOMNIA
Anesthesia Sleep
REM Sleep
REM Sleep Therapy
PROSOMNIA Sleep Health
PROSOMNIA Sleep Wellness
PROSOMNIA Sleep Treatment
Nyree
Nyree Penn
Propofol
Propofol Sleep
Diprivan
Diprivan Sleep
PROSOMNIA Sleep Health and Wellness
Insomnia
Sleep Deprivation
IH
Idiopathic Hypersomnia
Sleep Debt
PTSD
Mental Health
Anxiety
Depression
Lead sponsor: PROSOMNIA Sleep Health & Wellness
Sponsor class: INDUSTRY
Collaborators: name: Masimo Corporation
name: PROSOMNIA Sleep Health & Wellness
First posted: 2024-10-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This clinical trial follows a Single Group Assignment model, where all enrolled participants receive the same intervention-PROSOMNIA Sleep Therapy (PSTx). The model is open-label, meaning both the participants and researchers are aware of the treatment being administered. There is no placebo or control group in this trial, as the focus is to directly evaluate the safety and efficacy of PSTx for chronic insomnia and related REM sleep disorders.

The intervention involves the use of monitored anesthesia care (MAC) to induce and regulate REM sleep, using Diprivan/Propofol under the supervision of an Anesthesiologist and a Certified Anesthetist. Continuous EEG monitoring ensures proper sleep architecture is achieved during the therapy session, and adjustments are made in real-time to optimize therapeutic outcomes.
Primary purpose: TREATMENT

Brief summary: This clinical trial aims to evaluate the safety and efficacy of PROSOMNIA Sleep Therapy (PSTx) for individuals suffering from chronic insomnia, sleep deprivation, and REM sleep disorders. Chronic insomnia, characterized by difficulty falling or staying asleep, significantly affects patients and quality of life, mood, and cognitive function. REM sleep disorders, in which the body struggles to enter or maintain restful REM sleep, can worsen these issues. The trial introduces a novel therapy using anesthesia-induced sleep, targeting sleep homeostasis and improving sleep architecture.

Objectives: The primary goals of the trial are to determine:

1. Whether PROSOMNIA Sleep Therapy increases the quality of REM sleep.
2. Whether PSTx increases the duration of REM and/or NREM sleep.
3. Whether PSTx decreases the time it takes participants to fall asleep (sleep onset latency).

Participants will receive ONE (1) PROSOMNIA Sleep Therapy session lasting between 60-120 minutes. Each session uses Diprivan/Propofol to induce sleep, and is monitored via an EEG to ensure proper sleep stages, particularly REM sleep.

Participant Criteria:

Inclusion: Adults aged 18-65 with diagnosed or undiagnosed chronic insomnia or sleep deprivation.

Exclusion: Patients with severe obesity, significant cardiovascular, neurological, or psychiatric conditions, or those with an ASA status above II.

Study Design: This trial is non-randomized, single-arm and open-label, with all participants receiving the PSTx. The trial does not include a comparison group, as the focus is on evaluating the immediate, direct effects of the therapy.

Participants will undergo continuous EEG monitoring during therapy sessions, allowing researchers to track brain activity and sleep stages in real-time. This method ensures that sleep cycles, particularly REM sleep, are optimized for therapeutic benefit.

Therapy Methodology:

PROSOMNIA Sleep Therapy leverages anesthesia to mimic natural sleep patterns and enhance the efficiency of REM sleep. Diprivan/Propofol is used to induce REM sleep, while EEG monitoring tracks and maintains proper sleep architecture throughout the session. The therapy promotes the clearance of adenosine, a compound that builds up during wakefulness and drives the need for sleep. Adenosine is cleared during REM sleep, reducing sleep pressure and improving cognitive function.

Outcome Measures:

Primary Outcomes: Researchers will measure the increase in REM sleep duration, improvement in sleep quality (via self-reported questionnaires), and a reduction in sleep onset latency.

Secondary Outcomes: These include changes in mood, cognitive function, and blood serum uric acid levels. Patient-reported outcomes will also be tracked through tools like the PROSOMNIA Sleep Quiz, which is specifically designed for PSTx.

Significance: Chronic insomnia and REM sleep disorders affect millions globally, leading to cognitive impairment, mood disturbances, and poor overall health. Traditional treatments, including pharmacological approaches and Cognitive Behavioral Therapy for Insomnia (CBT-I), often provide suboptimal results for many individuals. PSTx offers a novel, therapeutic approach to restoring sleep balance and enhancing the overall quality of sleep, particularly for those who have not responded to conventional treatments.

Study Process:

Recruitment and Baseline Assessments: Participants undergo a comprehensive sleep assessment, including sleep questionnaires and polysomnography, to establish a baseline for sleep quality and duration. Blood serum uric acid levels will also be measured to track any biochemical changes due to therapy.

Therapy Sessions: Only one (1) PROSOMNIA Sleep Therapy session will be administered, with the session lasting between 60-120 minutes. Diprivan/Propofol is used to induce sleep, and EEG will monitor brain activity to ensure the proper balance of sleep stages.

Post-Therapy Follow-up: Follow-up assessments will occur at 24 hours, 7 days, and 30 days post-treatment. Researchers will analyze the therapy effects on REM sleep, mood, cognitive function, and other health indicators.

Potential Implications: If successful, this trial could revolutionize how we treat sleep disorders by targeting the underlying mechanisms of sleep pressure and REM sleep disruption. PROSOMNIA Sleep Therapy may offer a safe, effective, and immediate alternative for patients who have exhausted other treatment options.

Key Concepts:

Homeostatic sleep drive, (Process S), caused by adenosine buildup during wakefulness, is disrupted by chronic insomnia. This impacts cognitive function health and recovery. Anesthesia-induced REM sleep via PSTx helps regulate this homeostatic sleep stage, offering deeper and more restorative sleep compared to other sleep therapies. The study uses statistical methods like ANOVA and Chi-square to measure outcomes.

Detailed description: The clinical trial aims to evaluate the safety and efficacy of PROSOMNIA Sleep Therapy (PSTx), an innovative anesthesia-induced treatment, for patients experiencing chronic insomnia, sleep deprivation, and REM sleep disorders. Chronic insomnia, characterized by persistent difficulty falling or staying asleep, often disrupts sleep homeostasis, affecting cognitive function, mood, and overall quality of life. Conventional treatments, such as Cognitive Behavioral Therapy for Insomnia (CBT-I) and pharmacological interventions, frequently yield suboptimal results, making this trial critical for those unresponsive to standard therapies.

Mechanism and Methodology:

PROSOMNIA Sleep Therapy uses a novel approach to target the homeostatic sleep drive by leveraging Diprivan/Propofol, an anesthetic that acts on GABA_A receptors to induce and maintain REM sleep. This process addresses sleep pressure caused by adenosine buildup during wakefulness, promoting its clearance during REM sleep. This controlled anesthesia-induced therapy aims to restore disrupted sleep homeostasis and optimize REM sleep architecture.

During the session, Diprivan/Propofol is administered under Monitored Anesthesia Care (MAC), with continuous EEG monitoring to ensure that sleep stages are appropriately maintained. The single-session therapy, lasting 60-120 minutes, not only aims to enhance REM sleep but also to reduce sleep onset latency (the time required to fall asleep) and improve overall sleep quality.

Study Objectives:

The primary objectives are to determine if PSTx increases REM sleep duration, reduces sleep onset latency, and improves overall sleep quality. Secondary objectives include assessing changes in mood, cognitive function, and biochemical markers (e.g., blood serum uric acid levels).

Broader Implications:

PROSOMNIA Sleep Therapy's innovative method could have broader applications beyond insomnia, including treating mental health disorders (e.g., depression, PTSD), neurodegenerative diseases (e.g., Alzheimer's), and enhancing cardiovascular and metabolic health. Athletes or individuals recovering from injury may also benefit from improved sleep quality and recovery.

Study Design:

This is a non-randomized, single-arm, open-label trial with all participants receiving PSTx to directly observe therapeutic effects without a comparison group. The design allows for focused assessment of therapy outcomes in patients unresponsive to conventional treatments.

Participant Criteria:

Inclusion: Adults aged 18-65 with diagnosed or undiagnosed chronic insomnia or sleep deprivation, with or without prior therapy.

Exclusion: Severe obesity (BMI \>35), cardiovascular, neurological, or psychiatric conditions that contraindicate anesthesia, ASA status above II, or diagnosed sleep disorders unrelated to insomnia.

Outcome Measures:

Primary Outcomes: Increased total REM sleep duration (via EEG), improved overall sleep quality (measured by validated questionnaires), and reduced sleep onset latency.

Secondary Outcomes: Changes in cognitive function, mood, and blood serum uric acid levels, tracked through questionnaires and laboratory analyses.

Study Process:

Participants will undergo a comprehensive sleep assessment using polysomnography (PSG) and sleep questionnaires to establish baseline sleep patterns. During the therapy session, Diprivan/Propofol will be administered under anesthesia care, with continuous EEG monitoring to optimize sleep stages. Follow-up assessments at 24 hours, 7 days, and 30 days post-therapy will evaluate changes in REM sleep, mood, cognitive function, and overall health.

Potential Impact:

If successful, this study could position PROSOMNIA Sleep Therapy as a rapid and effective alternative to traditional insomnia treatments, offering hope for individuals unresponsive to current therapies. The study will provide new insights into adenosine clearance, REM sleep regulation, and their roles in cognitive recovery and mood stabilization.

Statistical Analysis:

Primary and Secondary Outcomes: Changes in continuous variables (e.g., REM sleep duration, sleep latency, uric acid levels) will be analyzed using Paired t-tests and ANOVA. Categorical outcomes (e.g., adverse events) will be analyzed using Chi-square tests. Non-normally distributed variables will be evaluated using the Wilcoxon Signed-Rank Test.

Predictive Analysis: Logistic regression will identify baseline variables that predict therapeutic outcomes.

Conclusion:

This trial aims to demonstrate that PROSOMNIA Sleep Therapy can effectively restore sleep homeostasis and improve REM sleep quality, providing a new avenue for treating chronic insomnia and associated conditions. The results could revolutionize the treatment landscape for sleep disorders, particularly in patients who have not found relief with existing options.

The findings will contribute significantly to the field of sleep medicine and open doors for further research in diverse clinical populations, improving sleep health and overall well-being.

Eligibility criteria: 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 age Reason: 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.
2. Diagnosed or Undiagnosed Chronic Insomnia:

   Reason: Included subjects have a consistent pattern of sleep disturbances that PROSOMNIA Sleep Therapy aims to treat.
3. Diagnosed or Undiagnosed Sleep Deprivation:

   Reason: Includes individuals who are not getting enough sleep quantity, which is a key condition that the PROSOMNIA Sleep Therapy aims to address.
4. Diagnosed or Undiagnosed REM Sleep Inconsistencies:

   Reason: Includes individuals who are not getting enough sleep quality and those with specific REM sleep phase issues that the PROSOMNIA Sleep Therapy is designed to improve.
5. Failure to Respond to Conventional Sleep Treatments:

   Reason: Focuses on subjects who have not found relief from existing sleep therapies, ensuring that the study population represents those in need of alternative solutions.
6. Ability to Provide Informed Consent:

Reason: Ensures that participants understand the study and agree to participate voluntarily.

EXCLUSION CRITERIA:

1. Severe Obesity (BMI \&gt; 40):

   Reason: Severe obesity can increase the risk of complications with anesthesia and may affect sleep patterns in ways that could confound study results.
2. Cardiovascular Conditions:

   Reason: Patients with significant heart conditions are at higher risk for complications during anesthesia.
3. Neurological Disorders:

   Reason: These diagnosed conditions and medications such as epilepsy could interfere with sleep patterns and responses to sleep therapy.
4. Other Health Conditions Contraindicating Anesthesia:

   Reason: Includes any condition that would make the use of anesthesia unsafe.
5. Greater than ASA II Status:

   Reason: The American Society of Anesthesiologists (ASA) physical status classification system classifies patients based on their pre-anesthesia medical conditions. Excluding those above ASA II ensures that only patients with mild systemic disease are included, to minimize risks.
6. Current Use of Prohibited Medications:

   Reason: 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.
7. Pregnancy or Breastfeeding:

Reason: Ensures the safety of the fetus or infant, as the effects of the PROSOMNIA Sleep therapy on pregnancy or lactation are unknown.

Primary outcomes:
measure: Reduction in Homeostatic Sleep Pressure
timeFrame: 60-120 minutes
measure: Change in Sleep Onset Latency
timeFrame: 30 days
measure: Change in REM Sleep Duration
timeFrame: 30 days
measure: Change in Overall Sleep Health
timeFrame: 30 days
Secondary outcomes:
measure: Changes in Blood Serum Uric Acid Levels
timeFrame: 60-120 minutes
measure: Improvement in Patient-Reported Mood
timeFrame: 30 days
Other outcomes:
measure: Adverse Event Reporting
timeFrame: 6 months
measure: PROSOMNIA Sleep Virtual Consultation Note
timeFrame: 30 days
Locations:
city: Aventura
country: United States
facility: PROSOMNIA Sleep Health and Wellness
state: Florida
Study officials:
affiliation: Memorial Healthcare System
name: Nyree Penn, MHSc., CAA, Master of Health Science
role: PRINCIPAL_INVESTIGATOR
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