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The purpose of this research is to examine the application of AutoCPAP with and without SensAwake in subjects with OSA and Post-Traumatic Stress Disorder (PTSD), and evaluate whether patients achieve better sleep quality and compliance with SensAwake, compared to the same treatment without SensAwake.
Conceptually, awareness of pressure occurs only during wakefulness. Thus reducing the pressure during wakefulness may improve therapy comfort and potentially adherence without compromising therapy efficacy. SensAwake™ is a unique pressure relief technology developed by Fisher & Paykel Healthcare which detects irregularity in the flow signal indicative of the transition from sleep to wake. When the transition from sleep to wake is detected the device promptly reduces the pressure to help facilitate a return to sleep.
It is hypothesised that AutoCPAP with SensAwake will improve patient comfort and compliance in the PTSD and OSA patients who are naïve to CPAP therapy.
The investigators will not be blinded to the study. The participants will be blinded to the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AutoCPAP with SensAwake On, then SenAwake Off | Experimental | Participants will start AutoCPAP treatment with SensAwake on for 4 weeks. After 4 weeks, the will cross over to SensAwake off for another 4 weeks. |
|
| AutoCPAP with SensAwake Off, then SensAwake On | Experimental | Participants will start AutoCPAP treatment with SensAwake Off for 4 weeks. After 4 weeks, the will cross over to SensAwake On for another 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AutoCPAP with SensAwake On | Device | The comfort feature 'SensAwake' will be turned on |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adherence (Hours on Therapy) | Hours per night averaged over total time period measured. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Quality (Epworth Sleepiness Scale (ESS) | The ESS is a validated questionnaire that assesses an idnviduals likelihood of falling asleep in a variety of given situations (such as having a conversation with someone or stopped a red light while driving.) Each question is given a rating between 0 and 3, with 0 being no chance of falling asleep and 3 being high chance of falling asleep. Answers are then summed together to determine the level of sleepiness an individual is experiencing with a maximum score of 24. The higher the score, the more sleepy the person is. From a clinical perspective an ESS score of 0-10 indicates a normal level sleepiness, a score of 11-14 indicates mild sleepiness, a score of 15-17 indicates moderate sleepiness and a score of 18+ indicates severe sleepiness. Results below are reported as a mean change from baseline in which negative scores indicate reduction in ESS from baseline (less sleepiness). Positive scores indicate increase in ESS from baseline (more sleepiness.) |
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Inclusion Criteria:
Male and female subjects > 18 years Diagnosed with OSA by a practicing sleep physician, within the last six months Diagnosed with post-traumatic stress disorder as diagnosed by a behavioral health professional, and quantified by McChord PTSD checklist All races and ethnicities will be included Naïve to CPAP therapy (has not used CPAP within the last 5 years)
Exclusion Criteria:
< 18 years of age if mental status is questionable, the patient will be excluded at the discretion of the consenting provider Unable/unwilling to follow the directions necessary for CPAP use Patients contraindicated for CPAP/AutoCPAP, at the discretion of the consenting provider
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| Name | Affiliation | Role |
|---|---|---|
| Aaron B Holley, MD | Walter Reed National Military Medical Center | Principal Investigator |
| Rebecca Thomson, MA | Fisher & Paykel Healthcare | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Walter Reed National Military Medical Center | Bethesda | Maryland | 20889 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31691105 | Derived | Holley A, Shaha D, Costan-Toth C, Slowik J, Robertson BD, Williams SG, Terry S, Golden D, Andrada T, Skeete S, Sheikh K, Butler G, Collen JF. A randomized, placebo-controlled trial using a novel PAP delivery platform to treat patients with OSA and comorbid PTSD. Sleep Breath. 2020 Sep;24(3):1001-1009. doi: 10.1007/s11325-019-01936-x. Epub 2019 Nov 6. |
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| ID | Title | Description |
|---|---|---|
| FG000 | AutoCPAP With SensAwake On First, Then SensAwake Off | Randomized participants in this group will experience SensAwake On first while using AutoCPAP for the first 4 weeks of the intervention. After 4 weeks, participants will cross over to the opposite arm and complete 4 weeks with SensAwake off while using AutoCPAP. |
| FG001 | AutoCPAP With SensAwake Off First, Then SensAwake On | Randomized participants in this group will experience SensAwake Off first while using AutoCPAP for the first 4 weeks of the intervention. After 4 weeks, participants will cross over to the opposite arm and complete 4 weeks with SensAwake on while using AutoCPAP. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AutoCPAP With SensAwake On First, Then SensAwake Off | Randomized participants in this group will experience SensaAwake On first while using AutoCPAP for the first 4 weeks of the intervention. After 4 weeks, participants will cross over to the opposite arm and complete 4 weeks with SensAwake off while using AutoCPAP. |
| BG001 |
| 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 | Adherence (Hours on Therapy) | Hours per night averaged over total time period measured. | Posted | Mean | Full Range | Hours/night | 4 weeks |
|
|
8 weeks
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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 | AutoCPAP With SensAwake On | Includes data for all participants who were exposed at any point of the 8 week study to SensAwake On. Due to drop outs, not all participants were exposed to this intervention. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Scientist | Fisher & Paykel Healthcare | +64 09 574 0100 | 7044 | CPAPtrial@fphcare.co.nz |
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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 | Jun 6, 2014 | Jul 2, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| AutoCPAP with SensAwake Off | Device | The comfort feature 'SensAwake' will be turned off |
|
| Change from Baseline after 4 weeks |
| Insomnia Severity Index (ISI) | ISI; 0-7 = No clinically significant insomnia, 8-14 = Sub threshold insomnia, 15-21 = Clinical insomnia (moderate severity), 22-28 = Clinical insomnia (severe). Results reported in mean change from baseline. Negative scores indicate improvement in ISI, positive scores indicate increase in ISI. | Change from Baseline after 4 weeks |
| AutoCPAP With SensAwake Off First, Then SensAwake On |
Randomized participants in this group will experience SensaAwake Off first while using AutoCPAP for the first 4 weeks of the intervention. After 4 weeks, participants will cross over to the opposite arm and complete 4 weeks with SensAwake On while using AutoCPAP. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Secondary | Sleep Quality (Epworth Sleepiness Scale (ESS) | The ESS is a validated questionnaire that assesses an idnviduals likelihood of falling asleep in a variety of given situations (such as having a conversation with someone or stopped a red light while driving.) Each question is given a rating between 0 and 3, with 0 being no chance of falling asleep and 3 being high chance of falling asleep. Answers are then summed together to determine the level of sleepiness an individual is experiencing with a maximum score of 24. The higher the score, the more sleepy the person is. From a clinical perspective an ESS score of 0-10 indicates a normal level sleepiness, a score of 11-14 indicates mild sleepiness, a score of 15-17 indicates moderate sleepiness and a score of 18+ indicates severe sleepiness. Results below are reported as a mean change from baseline in which negative scores indicate reduction in ESS from baseline (less sleepiness). Positive scores indicate increase in ESS from baseline (more sleepiness.) | Posted | Mean | Standard Deviation | score on a scale | Change from Baseline after 4 weeks |
|
|
|
| Secondary | Insomnia Severity Index (ISI) | ISI; 0-7 = No clinically significant insomnia, 8-14 = Sub threshold insomnia, 15-21 = Clinical insomnia (moderate severity), 22-28 = Clinical insomnia (severe). Results reported in mean change from baseline. Negative scores indicate improvement in ISI, positive scores indicate increase in ISI. | Posted | Mean | Standard Deviation | score on a scale | Change from Baseline after 4 weeks |
|
|
|
| 0 |
| 71 |
| 0 |
| 71 |
| 0 |
| 71 |
| EG001 | AutoCPAP With SensAwake Off | Includes data for all participants who were exposed at any point of the 8 week study to SensAwake Off. Due to drop outs, not all participants were exposed to this intervention. | 0 | 72 | 0 | 72 | 0 | 72 |
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |