Trial Outcomes & Findings for Comparison Study Using APAP With and Without SensAwake in Patients With OSA and PTSD (NCT NCT02549508)

Results Overview

Hours per night averaged over total time period measured.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

85 participants

Primary outcome timeframe

4 weeks

Results posted on

2020-11-10

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	47	38
Overall Study COMPLETED	33	21
Overall Study NOT COMPLETED	14	17

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AutoCPAP With SensAwake On First, Then SensAwake Off n=47 Participants 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.	AutoCPAP With SensAwake Off First, Then SensAwake On n=38 Participants 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.	Total n=85 Participants Total of all reporting groups
Age, Continuous	38.0 years STANDARD_DEVIATION 8.0 • n=47 Participants	37.7 years STANDARD_DEVIATION 8.6 • n=38 Participants	37.9 years STANDARD_DEVIATION 8.3 • n=85 Participants
Sex: Female, Male Female	7 Participants n=47 Participants	5 Participants n=38 Participants	12 Participants n=85 Participants
Sex: Female, Male Male	40 Participants n=47 Participants	33 Participants n=38 Participants	73 Participants n=85 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	47 participants n=47 Participants	38 participants n=38 Participants	85 participants n=85 Participants

PRIMARY outcome

Timeframe: 4 weeks

Hours per night averaged over total time period measured.

Outcome measures

Outcome measures
Measure	AutoCPAP With SensAwake On n=29 Participants Analysis of all participants who completed the AutoCPAP with SensAwake on arm.	AutoCPAP With SensAwake Off First n=25 Participants Analysis of all participants who completed the AutoCPAP with SensAwake off arm
Adherence (Hours on Therapy)	1.1 Hours/night Interval 1.1 to 4.8	0.5 Hours/night Interval 0.0 to 2.7

SECONDARY outcome

Timeframe: 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.)

Outcome measures

Outcome measures
Measure	AutoCPAP With SensAwake On n=29 Participants Analysis of all participants who completed the AutoCPAP with SensAwake on arm.	AutoCPAP With SensAwake Off First n=25 Participants Analysis of all participants who completed the AutoCPAP with SensAwake off arm
Sleep Quality (Epworth Sleepiness Scale (ESS)	-2.4 score on a scale Standard Deviation 4.5	-3.0 score on a scale Standard Deviation 4.4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	AutoCPAP With SensAwake On n=29 Participants Analysis of all participants who completed the AutoCPAP with SensAwake on arm.	AutoCPAP With SensAwake Off First n=25 Participants Analysis of all participants who completed the AutoCPAP with SensAwake off arm
Insomnia Severity Index (ISI)	-4.2 score on a scale Standard Deviation 4.5	-4.4 score on a scale Standard Deviation 4.7

Adverse Events

AutoCPAP With SensAwake On

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

AutoCPAP With SensAwake Off

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Clinical Research Scientist

Fisher & Paykel Healthcare

Phone: +64 09 574 0100

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place