Trial Title:
Evaluating the Efficacy and Safety of PROSOMNIA Sleep Therapy™ in Patients With Sleep Deprivation and Chronic Insomnia
NCT ID:
NCT06644573
Condition:
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
Conditions: Official terms:
Alzheimer Disease
Sleep Initiation and Maintenance Disorders
Sleep Wake Disorders
Parasomnias
Sleep Deprivation
Disorders of Excessive Somnolence
REM Sleep Behavior Disorder
Idiopathic Hypersomnia
Sleep Disorders, Circadian Rhythm
Chronobiology Disorders
Disease
Cancer Pain
Fractures, Stress
Depression
Anxiety Disorders
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Mental Disorders
Problem Behavior
Propofol
Conditions: 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
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
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
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
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.
Arm group label:
Single-Arm - PROSOMNIA Sleep Therapy
Intervention type:
Procedure
Intervention name:
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.
Arm group label:
Single-Arm - PROSOMNIA Sleep Therapy
Other name:
PROSOMNIA Sleep Therapy
Other name:
PSTx
Other name:
PROSOMNIA Sleep
Intervention type:
Drug
Intervention name:
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.
Arm group label:
Single-Arm - PROSOMNIA Sleep Therapy
Other name:
Propofol
Intervention type:
Device
Intervention name:
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.
Arm group label:
Single-Arm - PROSOMNIA Sleep Therapy
Other name:
SedLine Brain Function Monitoring
Other name:
MASIMO SedLine EEG
Other name:
EEG
Other name:
SedLine
Other name:
MASIMO
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.
Criteria for 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 > 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
PROSOMNIA Sleep Health and Wellness
Address:
City:
Aventura
Zip:
33180
Country:
United States
Contact:
Last name:
Nyree Penn, MHSc., CAA, Master of Health Science
Phone:
754-303-2178
Email:
Nyree@prosomniasleep.com
Contact backup:
Last name:
David Legros, Medical Doctor- Anesthesia
Phone:
216-570-2706
Email:
dlegros116@me.com
Investigator:
Last name:
Nyree Penn, MHSc., CAA, Master of Health Science
Email:
Principal Investigator
Investigator:
Last name:
David Legros, Medical Doctor- Anesthesia
Email:
Sub-Investigator
Start date:
November 1, 2024
Completion date:
May 1, 2025
Lead sponsor:
Agency:
Nyree Penn
Agency class:
Industry
Collaborator:
Agency:
Masimo Corporation
Agency class:
Industry
Collaborator:
Agency:
PROSOMNIA Sleep Health & Wellness
Agency class:
Industry
Source:
PROSOMNIA Sleep Health & Wellness
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06644573
https://prosomniasleep.com/m/login?r=%2Fclinical-trials
https://prosomniasleep.com/
