Trial Outcomes & Findings for Nexus Compliance Study (NCT NCT01013207)

NCT ID: NCT01013207

Last Updated: 2010-09-08

Results Overview

Compliance on CPAP was measured as average daily usage

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 50 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2010-09-08

Participant Flow

Participants recruited from ResMed Science Centre, Sydney, between November 2009 and March 2010

Participant milestones

Measure	All Participants
CPAP Pre Nexus (S9) STARTED	50
CPAP Pre Nexus (S9) COMPLETED	50
CPAP Pre Nexus (S9) NOT COMPLETED	0
Nexus (S9) STARTED	50
Nexus (S9) COMPLETED	50
Nexus (S9) NOT COMPLETED	0
CPAP Post Nexus (S9) STARTED	50
CPAP Post Nexus (S9) COMPLETED	44
CPAP Post Nexus (S9) NOT COMPLETED	6

Reasons for withdrawal

Measure	All Participants
CPAP Post Nexus (S9) Lost to Follow-up	6

Baseline Characteristics

Nexus Compliance Study

Baseline characteristics by cohort

Measure	All Participants n=50 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	35 Participants n=5 Participants
Age, Categorical >=65 years	15 Participants n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	32 Participants n=5 Participants
Region of Enrollment Australia	50 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Compliance on CPAP was measured as average daily usage

Outcome measures

Measure	All Participants n=50 Participants
Compliance on CPAP CPAP Pre Nexus (S9)	6.58 Hours Standard Deviation 1.95
Compliance on CPAP Nexus (S9)	7.07 Hours Standard Deviation 1.2
Compliance on CPAP CPAP Post Nexus (S9)	6.72 Hours Standard Deviation 1.2

SECONDARY outcome

Timeframe: 4 weeks

The usability quesitonnaire was administered at the end of the 4 week trial of Nexus (S9). Usability was defined as ease of using the Nexus (S9) and overall satisfaction with the Nexus (S9) CPAP. The outcome measure was collected through 11 point Likert questionnaires, where 0 = very poor usability and 10 = excellent usability.

Outcome measures

Measure	All Participants n=50 Participants
Usability of the Nexus (S9) CPAP.	9.48 Units on a scale Standard Deviation 1.03

Adverse Events

All Participants

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

Alison Wimms

ResMed Ltd

Phone: +61 8884 2583

Email: alison.wimms@resmed.com.au

Results disclosure agreements

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