Obstructive Sleep Apnea (OSA), Post-Traumatic Stress Disorder (PTSD)
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEAutoCPAP with SensAwake On
The comfort feature 'SensAwake' will be turned on
DEVICEAutoCPAP with SensAwake Off
The comfort feature 'SensAwake' will be turned off
Sponsors
Fisher and Paykel Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence (Hours on Therapy) | 4 weeks | Hours per night averaged over total time period measured. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Quality (Epworth Sleepiness Scale (ESS) | Change from Baseline after 4 weeks | 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.) |
| Insomnia Severity Index (ISI) | Change from Baseline after 4 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 47 |
| 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. | 38 |
| Total | 85 |
Baseline characteristics
| Characteristic | AutoCPAP With SensAwake Off First, Then SensAwake On | Total | AutoCPAP With SensAwake On First, Then SensAwake Off |
|---|---|---|---|
| Age, Continuous | 37.7 years STANDARD_DEVIATION 8.6 | 37.9 years STANDARD_DEVIATION 8.3 | 38.0 years STANDARD_DEVIATION 8 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 38 participants | 85 participants | 47 participants |
| Sex: Female, Male Female | 5 Participants | 12 Participants | 7 Participants |
| Sex: Female, Male Male | 33 Participants | 73 Participants | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 71 | 0 / 72 |
| other Total, other adverse events | 0 / 71 | 0 / 72 |
| serious Total, serious adverse events | 0 / 71 | 0 / 72 |
Outcome results
Primary
Adherence (Hours on Therapy)
Hours per night averaged over total time period measured.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| AutoCPAP With SensAwake On | Adherence (Hours on Therapy) | 1.1 Hours/night |
| AutoCPAP With SensAwake Off First | Adherence (Hours on Therapy) | 0.5 Hours/night |
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.
Time frame: Change from Baseline after 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AutoCPAP With SensAwake On | Insomnia Severity Index (ISI) | -4.2 score on a scale | Standard Deviation 4.5 |
| AutoCPAP With SensAwake Off First | Insomnia Severity Index (ISI) | -4.4 score on a scale | Standard Deviation 4.7 |
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.)
Time frame: Change from Baseline after 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AutoCPAP With SensAwake On | Sleep Quality (Epworth Sleepiness Scale (ESS) | -2.4 score on a scale | Standard Deviation 4.5 |
| AutoCPAP With SensAwake Off First | Sleep Quality (Epworth Sleepiness Scale (ESS) | -3.0 score on a scale | Standard Deviation 4.4 |