Trial Outcomes & Findings for Pilairo Lab Market Research (NCT NCT01824979)

Results Overview

Measured from a single item, sleep technicians indicated their experience using the Pilairo or Other CPAP mask during the CPAP titration. Response options ranged on a scale from 0 to 10 with 0 indicating an extremely poor experience and 10 indicating and extremely pleasant experience.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

100 participants

Primary outcome timeframe

One night

Results posted on

2018-03-09

Participant Flow

Participant milestones

Participant milestones
Measure	Pilairo Pilairo nasal pillows mask during CPAP titration CPAP mask ( Pilairo)	Other CPAP Mask Other CPAP mask during CPAP titration Other CPAP mask
Overall Study STARTED	50	50
Overall Study COMPLETED	37	37
Overall Study NOT COMPLETED	13	13

Reasons for withdrawal

Reasons for withdrawal
Measure	Pilairo Pilairo nasal pillows mask during CPAP titration CPAP mask ( Pilairo)	Other CPAP Mask Other CPAP mask during CPAP titration Other CPAP mask
Overall Study Withdrawal by Subject	5	0
Overall Study Physician Decision	2	0
Overall Study Protocol Violation	6	13

Baseline Characteristics

Pilairo Lab Market Research

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pilairo n=50 Participants Pilairo nasal pillows mask during CPAP titration CPAP mask ( Pilairo)	Other CPAP Mask n=50 Participants Other CPAP mask during CPAP titration Other CPAP mask	Total n=100 Participants Total of all reporting groups
Age, Customized ≥ 18 years	50 Participants n=93 Participants	50 Participants n=4 Participants	100 Participants n=27 Participants
Sex: Female, Male Female	10 Participants n=93 Participants	19 Participants n=4 Participants	29 Participants n=27 Participants
Sex: Female, Male Male	40 Participants n=93 Participants	31 Participants n=4 Participants	71 Participants n=27 Participants
Region of Enrollment United States	50 Participants n=93 Participants	50 Participants n=4 Participants	100 Participants n=27 Participants

PRIMARY outcome

Timeframe: One night

Population: While not all participants completed the full study, a number of participants had completed enough of the study to provide data to analyze. For this outcome measure, 48 participants in the Pilairo Group had usable data for analysis while 42 participants in the Other CPAP mask group had usable data for analysis for this measure.

Measured from a single item, sleep technicians indicated their experience using the Pilairo or Other CPAP mask during the CPAP titration. Response options ranged on a scale from 0 to 10 with 0 indicating an extremely poor experience and 10 indicating and extremely pleasant experience.

Outcome measures

Outcome measures
Measure	Pilairo n=48 Participants Pilairo nasal pillows mask during CPAP titration CPAP mask ( Pilairo)	Other CPAP Mask n=42 Participants Other CPAP mask during CPAP titration Other CPAP mask
Technician Experience With Mask	8.46 Units on a Scale Interval 0.0 to 10.0	8.24 Units on a Scale Interval 0.0 to 10.0

SECONDARY outcome

Timeframe: One night

Population: While not all participants completed the full study, a number of participants had completed enough of the study to provide data to analyze. For this outcome measure, 48 participants in the Pilairo Group had usable data for analysis while 42 participants in the Other CPAP mask group had usable data for analysis for this measure.

Sleep technicians reported the number of times they had to intervene with the mask to get a good seal or improve comfort.

Outcome measures

Outcome measures
Measure	Pilairo n=48 Participants Pilairo nasal pillows mask during CPAP titration CPAP mask ( Pilairo)	Other CPAP Mask n=42 Participants Other CPAP mask during CPAP titration Other CPAP mask
Number of Mask Interventions During the Night	1.29 units on a scale Interval 0.0 to 5.0	2.20 units on a scale Interval 0.0 to 5.0

Adverse Events

Pilairo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Other CPAP Mask

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

Clinical Research Scientist

Fisher and Paykel Healthcare

Phone: + 64 09 574 0100

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place