Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06644573
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-08
Brief Title:
Evaluating the Efficacy and Safety of PROSOMNIA Sleep Therapy in Patients with Sleep Deprivation and Chronic Insomnia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluating the Efficacy and Safety of PROSOMNIA Sleep Therapy in Patients with Sleep Deprivation and Chronic Insomnia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PSHW
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 andor 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 DiprivanPropofol 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 DiprivanPropofol 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 DiprivanPropofol 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
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 andor 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 DiprivanPropofol 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 DiprivanPropofol 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 DiprivanPropofol 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 DiprivanPropofol 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 DiprivanPropofol 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 eg blood serum uric acid levels
Broader Implications
PROSOMNIA Sleep Therapys innovative method could have broader applications beyond insomnia including treating mental health disorders eg depression PTSD neurodegenerative diseases eg Alzheimers 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 DiprivanPropofol 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 eg REM sleep duration sleep latency uric acid levels will be analyzed using Paired t-tests and ANOVA Categorical outcomes eg 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
Mechanism and Methodology
PROSOMNIA Sleep Therapy uses a novel approach to target the homeostatic sleep drive by leveraging DiprivanPropofol 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 DiprivanPropofol 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 eg blood serum uric acid levels
Broader Implications
PROSOMNIA Sleep Therapys innovative method could have broader applications beyond insomnia including treating mental health disorders eg depression PTSD neurodegenerative diseases eg Alzheimers 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 DiprivanPropofol 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 eg REM sleep duration sleep latency uric acid levels will be analyzed using Paired t-tests and ANOVA Categorical outcomes eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None