Trial Outcomes & Findings for Evaluation of Acclimate Feature for Positive Airway Pressure (PAP) Therapy (NCT NCT01421654)

Last Updated: 2013-03-12

Results Overview

The number of hours that each group used the device will be compared between subjects using fixed pressure with the Acclimate mode and subjects using fixed pressure without the Acclimate mode.

Recruitment status

COMPLETED

Study phase

Target enrollment

20 participants

Primary outcome timeframe

30 days

Results posted on

2013-03-12

Participant Flow

The study was conducted at one (1) clinical site in the US. The first subject was consented 06Sept2011 (Subject 01) and the last subject consented on 23Nov2011 (Subject 23).

Participant milestones

Participant milestones
Measure	Fixed Mode + Acclimate S9 Elite flow generator with Acclimate feature activated.	Fixed Mode Only S9 Elite Flow Generator with Fixed Mode only
Overall Study STARTED	11	9
Overall Study COMPLETED	11	9
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Acclimate Feature for Positive Airway Pressure (PAP) Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fixed Mode + Acclimate n=11 Participants S9 Elite flow generator with Acclimate feature activated.	Fixed Mode Only n=9 Participants S9 Elite Flow Generator with Fixed Mode only	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	6 Participants n=7 Participants	16 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Age Continuous	52.3 years STANDARD_DEVIATION 11.2 • n=5 Participants	58.5 years STANDARD_DEVIATION 9.2 • n=7 Participants	55.1 years STANDARD_DEVIATION 10.1 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants	9 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

The number of hours that each group used the device will be compared between subjects using fixed pressure with the Acclimate mode and subjects using fixed pressure without the Acclimate mode.

Outcome measures

Outcome measures
Measure	Fixed Mode + Acclimate n=11 Participants S9 Elite flow generator with Acclimate feature activated.	Fixed Mode Only n=9 Participants S9 Elite Flow Generator with Fixed Mode only
Hours Used	146.9 Total Hours Used Standard Deviation 62.9	141.9 Total Hours Used Standard Deviation 64.8

Adverse Events

Fixed Mode + Acclimate

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Fixed Mode Only

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

Amy Blase/Clinical Research Manager

ResMed

Phone: 858-836-6715

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60