Trial Outcomes & Findings for Revised Algorithm for Next Generation DeVilbiss Healthcare AutoAdjust Continuous Positive Airway Pressure (CPAP) (NCT NCT01797705)

Results Overview

The primary objective for the study was demonstrating effectiveness of therapy provided by the DeVilbiss AutoAdjust device as reported by the expert human reviewer. The primary endpoint was that expert human reviewer should agree with pressure changes made by the machine during each 20-minute epoch at least 80% of the time. Expert human reviewer reviewed each study and made a determination at 20-minute time points, in context of REM/NON-REM sleep and supine/non-supine positions, marking the machine pressure response with an "agree" or "disagree." Pressure changes might show no change, increase or decrease during the 20-minute epoch.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

33 participants

Primary outcome timeframe

1 night

Results posted on

2015-05-29

Participant Flow

Participant milestones

Participant milestones
Measure	All Subjects All enrolled subjects
Overall Study STARTED	33
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	All Subjects All enrolled subjects
Overall Study Equipment anomalies during sleep studies	4
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Revised Algorithm for Next Generation DeVilbiss Healthcare AutoAdjust Continuous Positive Airway Pressure (CPAP)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Evaluable Subjects n=28 Participants All subjects completing the one-night sleep study with evaluable results.
Age, Continuous	54.0 years STANDARD_DEVIATION 13.1 • n=99 Participants
Sex: Female, Male Female	12 Participants n=99 Participants
Sex: Female, Male Male	16 Participants n=99 Participants
Apnea Type at Enrollment Obstructive Sleep Apnea	26 participants n=99 Participants
Apnea Type at Enrollment Central Sleep Apnea	2 participants n=99 Participants

PRIMARY outcome

Timeframe: 1 night

Population: Subjects completing the study with evaluable results

The primary objective for the study was demonstrating effectiveness of therapy provided by the DeVilbiss AutoAdjust device as reported by the expert human reviewer. The primary endpoint was that expert human reviewer should agree with pressure changes made by the machine during each 20-minute epoch at least 80% of the time. Expert human reviewer reviewed each study and made a determination at 20-minute time points, in context of REM/NON-REM sleep and supine/non-supine positions, marking the machine pressure response with an "agree" or "disagree." Pressure changes might show no change, increase or decrease during the 20-minute epoch.

Outcome measures

Outcome measures
Measure	All Evaluable Subjects n=28 Participants All subjects completing the one-night sleep study with evaluable results.
% Agreement Between Reviewer and Machine Pressure Settings During Sleep Study	92.2 percentage of agreement Interval 89.9 to 94.2

Adverse Events

Evaluable Subjects

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

Jim Froehlich

DeVilbiss Healthcare

Phone: 814-443-7692

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place