Trial Outcomes & Findings for CPAP In-home Assessment USA (NCT NCT02809859)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

139 participants

Primary outcome timeframe

6 months

Results posted on

2019-03-05

Participant Flow

Participant milestones

Participant milestones
Measure	Investigational CPAP Device Fisher \& Paykel Healthcare CPAP Device Fisher \& Paykel Healthcare CPAP Device: Fisher \& Paykel Healthcare CPAP Device
Overall Study STARTED	139
Overall Study COMPLETED	125
Overall Study NOT COMPLETED	14

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Age wasn't provided by one of the participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Investigational CPAP Device n=139 Participants Fisher \& Paykel Healthcare CPAP Device Fisher \& Paykel Healthcare CPAP Device: Fisher \& Paykel Healthcare CPAP Device
Age, Continuous	55.5 years n=138 Participants • Age wasn't provided by one of the participants
Sex: Female, Male Female	50 Participants n=139 Participants
Sex: Female, Male Male	89 Participants n=139 Participants

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	Investigational CPAP Device n=139 Participants Fisher \& Paykel Healthcare CPAP Device Fisher \& Paykel Healthcare CPAP Device: Fisher \& Paykel Healthcare CPAP Device
Apnea Hypopnea Index (AHI), Measured as Number of Events/Hour.	1.9 events/hr Standard Deviation 2.9

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	Investigational CPAP Device n=139 Participants Fisher \& Paykel Healthcare CPAP Device Fisher \& Paykel Healthcare CPAP Device: Fisher \& Paykel Healthcare CPAP Device
Log of Safety Related Events, Measured as Number of Participants That Experienced Unacceptable Safety Related Faults	0 participants

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	Investigational CPAP Device n=139 Participants Fisher \& Paykel Healthcare CPAP Device Fisher \& Paykel Healthcare CPAP Device: Fisher \& Paykel Healthcare CPAP Device
Machine Reported Faults, Measured as Number of Patients With Machine Faults	3 participants

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	Investigational CPAP Device n=139 Participants Fisher \& Paykel Healthcare CPAP Device Fisher \& Paykel Healthcare CPAP Device: Fisher \& Paykel Healthcare CPAP Device
Participant Reported Faults, Measured as Number of Participant Complaints	9 complaints

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	Investigational CPAP Device n=139 Participants Fisher \& Paykel Healthcare CPAP Device Fisher \& Paykel Healthcare CPAP Device: Fisher \& Paykel Healthcare CPAP Device
How Many Participants Slept Acceptably, Well or Very Well Throughout the Night on the CPAP Device	134 participants

Adverse Events

Investigational CPAP Device

Serious events: 2 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Investigational CPAP Device n=139 participants at risk Fisher \& Paykel Healthcare CPAP Device Fisher \& Paykel Healthcare CPAP Device: Fisher \& Paykel Healthcare CPAP Device
Respiratory, thoracic and mediastinal disorders Community acquired pneumonia	0.72% 1/139 • Number of events 1 • Adverse events were collected during the study period of each participant (i.e. 6 months)
Cardiac disorders Atrial Fibrillation	0.72% 1/139 • Number of events 1 • Adverse events were collected during the study period of each participant (i.e. 6 months)

Other adverse events

Adverse event data not reported

Additional Information

Clinical Research Scientist

Fisher & Paykel Healthcare

Phone: +64 9 574 0123

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place