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The study will determine which of two different types of positive airway pressure (PAP therapy) modes are more effective in reducing sleep breathing events in chronic insomnia patients and in decreasing insomnia severity.
Patients presenting to the sleep clinic with a primary complaint of insomnia will be potential participants for this study. Following diagnostic polysomnography (PSG) testing, insomnia patients diagnosed with SDB and meeting inclusion criteria will be randomized to a PAP treatment arm, CPAP or ASV. Participants will complete titration studies with their assigned PAP mode and attend clinical follow-up appointments over a 14-16 week timeframe. Titration PSG studies will assess PAP pressure needs to ensure that patients are receiving optimal therapy at all times during this study. PAP adaptation barriers will be addressed as they arise during the study, because it is important that participants are able to use PAP therapy nightly during participation in this protocol. Baseline scores on insomnia severity, sleep quality, subjective insomnia parameters, sleep related impairment, and quality of life will be compared to outcome measures at the 4 month mark. Pre-treatment and post-treatment objective improvements on sleep studies will also be compared including sleep breathing indices, sleep consolidation indices, and objective data download information.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous Positive Airway Pressure | Active Comparator | Continuous positive airway pressure (CPAP) intervention as active comparator. Provides a fixed pressure for both inspiration and expiration. |
|
| Adaptive Servo-Ventilation | Experimental | Adaptive servo-ventilation (ASV) positive airway pressure as experimental intervention. Provides a higher pressure for inspiration and a lower pressure for expiration with changes in the pressure support level to meet a target minute ventilation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AirCurve 10 ASV | Device | Device is able to provide both ASV therapy and CPAP therapy modes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Insomnia Severity Index | Change in insomnia severity from baseline to 4 months as measured by subjective questionnaire. The Insomnia Severity Index has seven questions. The seven answers are added up for a total score. Scores range from 0 - 28. A higher score indicates a more severe degree of insomnia. | Baseline and 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Quality Rating | 8 point Likert scale for change in subjective sleep quality from baseline to 4 months. Lower scores indicated more positive sleep quality. A score 0 indicates excellent sleep quality, and a score of 7 indicates very poor sleep quality | Baseline and 4 months |
| Global Morning Rating |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barry Krakow, MD | Sleep & Human Health Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maimonides Sleep Arts & Sciences | Albuquerque | New Mexico | 87109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31517263 | Derived | Krakow B, McIver ND, Ulibarri VA, Krakow J, Schrader RM. Prospective Randomized Controlled Trial on the Efficacy of Continuous Positive Airway Pressure and Adaptive Servo-Ventilation in the Treatment of Chronic Complex Insomnia. EClinicalMedicine. 2019 Aug 8;13:57-73. doi: 10.1016/j.eclinm.2019.06.011. eCollection 2019 Aug. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Continuous Positive Airway Pressure | Continuous positive airway pressure (CPAP) intervention as active comparator. Provides a fixed pressure for both inspiration and expiration. AirCurve 10 ASV: Device is able to provide both ASV therapy and CPAP therapy modes. |
| FG001 | Adaptive Servo-Ventilation | Adaptive servo-ventilation (ASV) positive airway pressure as experimental intervention. Provides a higher pressure for inspiration and a lower pressure for expiration with changes in the pressure support level to meet a target minute ventilation. AirCurve 10 ASV: Device is able to provide both ASV therapy and CPAP therapy modes. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline information available for ITT
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| ID | Title | Description |
|---|---|---|
| BG000 | Continuous Positive Airway Pressure | Continuous positive airway pressure (CPAP) intervention as active comparator. Provides a fixed pressure for both inspiration and expiration. AirCurve 10 ASV: Device is able to provide both ASV therapy and CPAP therapy modes. |
| BG001 | Adaptive Servo-Ventilation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Insomnia Severity Index | Change in insomnia severity from baseline to 4 months as measured by subjective questionnaire. The Insomnia Severity Index has seven questions. The seven answers are added up for a total score. Scores range from 0 - 28. A higher score indicates a more severe degree of insomnia. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 4 months |
|
4 months
Participants were asked to report side effects commonly related to CPAP usage, including:
Drying of the nose, mouth or throat, Nosebleed, Ear or sinus discomfort, Eye irritation, Skin rashes Participants may report multiple side effects
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Continuous Positive Airway Pressure | Continuous positive airway pressure (CPAP) intervention as active comparator. Provides a fixed pressure for both inspiration and expiration. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| mask leak | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Mask leak is a common side effect to CPAP treatment, and can lead to dry mouth (from mask/ mouth leak), congestion, and eye irritation |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Barry Krakow | Sleep and Human Health Institute | (505) 9987204 | bkrakow@sleeptreatment.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 7, 2014 | May 24, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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|
Change in subjective rating from baseline to 4 months based on a 0-100% scale. Lower scores equal a more positive experience |
| 4 months |
| Sleep Onset Latency | Change in from baseline to 4 months in sleep onset time (minutes) | 4 months |
| Wake After Sleep Onset (WASO) | Change from baseline to 4 months for WASO in minutes | 4 months |
| Sleep Efficiency | Change from baseline to 4 months in sleep efficiency (total sleep time/time in bed) | 4 months |
| Treatment intolerance |
|
Adaptive servo-ventilation (ASV) positive airway pressure as experimental intervention. Provides a higher pressure for inspiration and a lower pressure for expiration with changes in the pressure support level to meet a target minute ventilation. AirCurve 10 ASV: Device is able to provide both ASV therapy and CPAP therapy modes. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
Adaptive servo-ventilation (ASV) positive airway pressure as experimental intervention. Provides a higher pressure for inspiration and a lower pressure for expiration with changes in the pressure support level to meet a target minute ventilation.
AirCurve 10 ASV: Device is able to provide both ASV therapy and CPAP therapy modes.
|
|
| Secondary | Sleep Quality Rating | 8 point Likert scale for change in subjective sleep quality from baseline to 4 months. Lower scores indicated more positive sleep quality. A score 0 indicates excellent sleep quality, and a score of 7 indicates very poor sleep quality | Posted | Mean | Standard Deviation | score on a scale | Baseline and 4 months |
|
|
|
| Secondary | Global Morning Rating | Change in subjective rating from baseline to 4 months based on a 0-100% scale. Lower scores equal a more positive experience | Posted | Mean | Standard Deviation | units on a scale | 4 months |
|
|
|
| Secondary | Sleep Onset Latency | Change in from baseline to 4 months in sleep onset time (minutes) | Posted | Mean | Standard Deviation | minutes | 4 months |
|
|
|
| Secondary | Wake After Sleep Onset (WASO) | Change from baseline to 4 months for WASO in minutes | Posted | Mean | Standard Deviation | minutes | 4 months |
|
|
|
| Secondary | Sleep Efficiency | Change from baseline to 4 months in sleep efficiency (total sleep time/time in bed) | Posted | Mean | Standard Deviation | percentage of time in bed | 4 months |
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| 20 |
| 21 |
| EG001 | Adaptive Servo-Ventilation | Adaptive servo-ventilation (ASV) positive airway pressure as experimental intervention. Provides a higher pressure for inspiration and a lower pressure for expiration with changes in the pressure support level to meet a target minute ventilation. | 0 | 19 | 0 | 19 | 16 | 19 |
|
| dry mouth | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Dry mouth is a common complaint usually caused by mask leak or mouth breathing while using PAP |
|
| skin irritation | Skin and subcutaneous tissue disorders | Systematic Assessment | Skin irritation due to wearing a mask at night |
|
| mask related insomnia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Difficulty sleeping due to wearing a CPAP mask |
|
| mouth leak | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Discomfort due to air leaking from the mouth during CPAP use |
|
| congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Nasal congestion due to CPAP use |
|
| skin crease from mask | Skin and subcutaneous tissue disorders | Systematic Assessment | Facial marks due to wearing a CPAP mask at night |
|
| nose tickle/ burn | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Discomfort in nasal passages while using CPAP |
|
| aerophagia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Discomfort from swallowing air during CPAP use |
|
| eye irritation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Eye irritation due to mask leak (air leaking into eyes) during CPAP use |
|
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| D001523 |
| Mental Disorders |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |