An interventional study of AutoCPAP with SensAwake On and AutoCPAP with SensAwake Off in Obstructive Sleep Apnea (OSA) and Post-Traumatic Stress Disorder (PTSD), sponsored by Fisher and Paykel Healthcare. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-11-10.
Sponsored by Fisher and Paykel Healthcare · Not applicable, Interventional, and Treatment
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.
2,198 studies on the registry are indexed under Sleep Apnea, Obstructive; 470 are open to participants now.
This study's enrollment of 85 is above the median of 53 across 1,448 interventional studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →Fisher and Paykel Healthcare is the lead sponsor of 84 studies on the registry; 15 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 10 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
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
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.
Device: AutoCPAP with SensAwake On · Device: AutoCPAP with SensAwake Off
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.
Device: AutoCPAP with SensAwake On · Device: AutoCPAP with SensAwake Off
The comfort feature 'SensAwake' will be turned on
The comfort feature 'SensAwake' will be turned off
Adherence (Hours on Therapy)
Hours per night averaged over total time period measured.
Time frame: 4 weeks
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.)
Time frame: 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.
Time frame: Change from Baseline after 4 weeks
| Milestone | AutoCPAP With SensAwake On First, Then SensAwake Off | AutoCPAP With SensAwake Off First, Then SensAwake On |
|---|---|---|
| Started | 47 | 38 |
| Completed | 33 | 21 |
| Not completed | 14 | 17 |
Hours per night averaged over total time period measured.
| Hours/night | AutoCPAP With SensAwake On | AutoCPAP With SensAwake Off First |
|---|---|---|
| Adherence (Hours on Therapy) | 1.1 (1.1 to 4.8) | 0.5 (0.0 to 2.7) |
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.)
| score on a scale | AutoCPAP With SensAwake On | AutoCPAP With SensAwake Off |
|---|---|---|
| Sleep Quality (Epworth Sleepiness Scale (ESS) | -2.4 ± 4.5 | -3.0 ± 4.4 |
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.
| score on a scale | AutoCPAP With SensAwake On | AutoCPAP With SensAwake Off |
|---|---|---|
| Insomnia Severity Index (ISI) | -4.2 ± 4.5 | -4.4 ± 4.7 |
Collected over 8 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| AutoCPAP With SensAwake On | 0/71 (0%) | 0/71 (0%) | 0/71 (0%) |
| AutoCPAP With SensAwake Off | 0/72 (0%) | 0/72 (0%) | 0/72 (0%) |
| Age, Continuous(years) | AutoCPAP With SensAwake On First, Then SensAwake Off | AutoCPAP With SensAwake Off First, Then SensAwake On | Total |
|---|---|---|---|
| Mean | 38.0 ± 8.0 | 37.7 ± 8.6 | 37.9 ± 8.3 |
| Sex: Female, Male(Participants) | AutoCPAP With SensAwake On First, Then SensAwake Off | AutoCPAP With SensAwake Off First, Then SensAwake On | Total |
|---|---|---|---|
| Female | 7 | 5 | 12 |
| Male | 40 | 33 | 73 |
| Race and Ethnicity Not Collected(Participants) | AutoCPAP With SensAwake On First, Then SensAwake Off | AutoCPAP With SensAwake Off First, Then SensAwake On | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | AutoCPAP With SensAwake On First, Then SensAwake Off | AutoCPAP With SensAwake Off First, Then SensAwake On | Total |
|---|---|---|---|
| United States | 47 | 38 | 85 |
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