Trial Outcomes & Findings for AutoSet for Her Quality of Life Clinical Trial (NCT NCT02400073)

NCT ID: NCT02400073

Last Updated: 2019-10-02

Results Overview

The Functional Outcomes of Sleep Questionnaire (FOSQ) assesses quality of life based on self reported physical and mental health. The outcome measure is Change from Baseline FOSQ score at 3 months. The minimum score is 5 and the maximum score is 20. Higher scores represent a better outcome

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 122 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2019-10-02

Participant Flow

A total of 122 patients (25 from Spain and 97 from Germany) were enrolled in the study

Participant milestones

Measure	AutoSet for Her PAP Device Patients in this study will use the AutoSet for Her: A new AutoSetting Positive Airway Pressure (PAP) device designed specifically to treat female OSA AutoSet for Her: 3 months nightly usage of the AutoSet for Her device
Overall Study STARTED	122
Overall Study COMPLETED	111
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	AutoSet for Her PAP Device n=122 Participants Patients in this study will use the AutoSet for Her: A new AutoSetting Positive Airway Pressure (PAP) device designed specifically to treat female OSA AutoSet for Her: 3 months nightly usage of the AutoSet for Her device
Age, Continuous	53.7 years STANDARD_DEVIATION 9.5 • n=122 Participants
Sex: Female, Male Female	122 Participants n=122 Participants
Sex: Female, Male Male	0 Participants n=122 Participants
Region of Enrollment Germany	97 participants n=122 Participants
Region of Enrollment Spain	25 participants n=122 Participants

PRIMARY outcome

Timeframe: 3 months

The Functional Outcomes of Sleep Questionnaire (FOSQ) assesses quality of life based on self reported physical and mental health. The outcome measure is Change from Baseline FOSQ score at 3 months. The minimum score is 5 and the maximum score is 20. Higher scores represent a better outcome

Outcome measures

Measure	AutoSet for Her PAP Device n=111 Participants Patients in this study will use the AutoSet for Her: A new AutoSetting Positive Airway Pressure (PAP) device designed specifically to treat female OSA AutoSet for Her: 3 months nightly usage of the AutoSet for Her device
Assessment of Quality of Life Using the Functional Outcomes of Sleep Questionnaire (FOSQ)	1.9 score on a scale Standard Deviation 3.3

SECONDARY outcome

Timeframe: 3 months

assessment of sleep quality (sleep efficacy, amounts of deep sleep, amounts of REM sleep). The outcome measure is changes in sleep from baseline at 3 months

Outcome measures

Measure	AutoSet for Her PAP Device n=111 Participants Patients in this study will use the AutoSet for Her: A new AutoSetting Positive Airway Pressure (PAP) device designed specifically to treat female OSA AutoSet for Her: 3 months nightly usage of the AutoSet for Her device
Sleep Changes Assessed Through Polysomnography change in sleep efficacy	0.3 minutes Standard Deviation 2.1
Sleep Changes Assessed Through Polysomnography change in deep sleep	7 minutes Standard Deviation 3.1
Sleep Changes Assessed Through Polysomnography change in REM sleep	8.4 minutes Standard Deviation 0.5

Adverse Events

AutoSet for Her PAP Device

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

Senior Manager, Medical Affairs

ResMed

Phone: +61 8884 1123

Email: alison.wimms@resmed.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place