Trial Outcomes & Findings for Evaluation of Treatment Efficacy and Comfort of a Modified Positive Airway Pressure Device to Treat Obstructive Sleep Apnea. (NCT NCT02214238)

Results Overview

The participants apnea hypopnea index (AHI) will be assessed using the PSG data, device download data and the independent pressure-flow logger. The apnea-hypopnea index is the total number of sleep disordered breathing events divided by total sleep time.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

49 participants

Primary outcome timeframe

After 1 night in the sleep lab and 3 weeks use of the device in the home.

Results posted on

2017-04-24

Participant Flow

Participant milestones

Participant milestones
Measure	Market Released PAP Device First, Then Modified PAP Device Use of a market released PAP device first for 3 week (with a 4 day window) followed by an in lab sleep study. Patient then crossed over to use the modified PAP device for 3 weeks (with a 4 day window) followed by another in lab sleep study.	Modified PAP Device First, Then Market Released PAP Device Use of the modified PAP device first for 3 week (with a 4 day window) followed by an in lab sleep study. Patient then crossed over to use the market released PAP device for 3 weeks (with a 4 day window) followed by another in lab sleep study.
Overall Study STARTED	26	23
Overall Study COMPLETED	20	17
Overall Study NOT COMPLETED	6	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Treatment Efficacy and Comfort of a Modified Positive Airway Pressure Device to Treat Obstructive Sleep Apnea.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Market Released PAP Device First, Then Modified PAP Device n=26 Participants Use of a market released PAP device first for 3 week (with a 4 day window) followed by an in lab sleep study. Patient then crossed over to use the modified PAP device for 3 weeks (with a 4 day window) followed by another in lab sleep study.	Modified PAP Device First, Then Market Released PAP Device n=23 Participants Us of the modified PAP device first for 3 week (with a 4 day window) followed by an in lab sleep study. Patient then crossed over to use the market released PAP device for 3 weeks (with a 4 day window) followed by another in lab sleep study.	Total n=49 Participants Total of all reporting groups
Age, Continuous	63.2 years n=93 Participants	58.7 years n=4 Participants	60.9 years n=27 Participants
Sex: Female, Male Female	2 Participants n=93 Participants	1 Participants n=4 Participants	3 Participants n=27 Participants
Sex: Female, Male Male	24 Participants n=93 Participants	22 Participants n=4 Participants	46 Participants n=27 Participants
Region of Enrollment New Zealand	26 participants n=93 Participants	23 participants n=4 Participants	49 participants n=27 Participants

PRIMARY outcome

Timeframe: After 1 night in the sleep lab and 3 weeks use of the device in the home.

Population: The overall number of participants analyzed is represented independent to which arm the participant started. Out of 49 total patients at baseline, 37 had usable data for analysis after using each device. AHI was compared between devices independent of which order the participants used each device.

The participants apnea hypopnea index (AHI) will be assessed using the PSG data, device download data and the independent pressure-flow logger. The apnea-hypopnea index is the total number of sleep disordered breathing events divided by total sleep time.

Outcome measures

Outcome measures
Measure	Market Released PAP Device n=37 Participants Use of a market released PAP device PAP device	Modified PAP Device n=37 Participants Use of the modified PAP device PAP device
PAP Treatment Efficacy	4.2 Events per hour Standard Deviation 1.0	4.0 Events per hour Standard Deviation 1.0

SECONDARY outcome

Timeframe: After 1 night in the sleep lab and 3 weeks use of the device in the home.

Population: The overall number of participants analyzed is represented independent to which arm the participant started. Out of 49 total patients at baseline, 35 had usable data for analysis after using each device. PAP treatment comfort was compared between devices independent of which order the participants used each device.

Participants will be administered comfort questionnaires regarding the comfort of all devices. The range of responses is 1 to 5 with 1 being very uncomfortable to 5 being very comfortable.

Outcome measures

Outcome measures
Measure	Market Released PAP Device n=35 Participants Use of a market released PAP device PAP device	Modified PAP Device n=35 Participants Use of the modified PAP device PAP device
PAP Treatment Comfort	5 Units on a Scale Interval 1.0 to 5.0	5 Units on a Scale Interval 1.0 to 5.0

SECONDARY outcome

Timeframe: After 1 night in the sleep lab and 3 weeks use of the device in the home.

Population: The overall number of participants analyzed is represented independent to which arm the participant started. Out of 49 total patients at baseline, 31 had usable data for analysis after using both devices. Compliance was compared between devices independent of which order the participants used each device.

Participants therapy utilisation will be compared between the two devices using the device data download, and the independent pressure-flow logger.

Outcome measures

Outcome measures
Measure	Market Released PAP Device n=31 Participants Use of a market released PAP device PAP device	Modified PAP Device n=31 Participants Use of the modified PAP device PAP device
PAP Compliance	438 Minutes Standard Deviation 13	430 Minutes Standard Deviation 12

Adverse Events

Modified PAP Device

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Market Released PAP Device

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Modified PAP Device n=49 participants at risk Use of a modified PAP device for 3 more weeks.	Market Released PAP Device n=43 participants at risk Use of a market released PAP device for 3 more weeks.
Respiratory, thoracic and mediastinal disorders Snoring and somnolence	2.0% 1/49 • Number of events 1 • 6 Weeks	2.3% 1/43 • Number of events 1 • 6 Weeks
Respiratory, thoracic and mediastinal disorders Nose bleed	2.0% 1/49 • Number of events 1 • 6 Weeks	0.00% 0/43 • 6 Weeks
Respiratory, thoracic and mediastinal disorders Angioedema	0.00% 0/49 • 6 Weeks	2.3% 1/43 • Number of events 1 • 6 Weeks
Respiratory, thoracic and mediastinal disorders High AHI on PSG	0.00% 0/49 • 6 Weeks	2.3% 1/43 • Number of events 1 • 6 Weeks
Surgical and medical procedures Shoulder Operation	2.0% 1/49 • Number of events 1 • 6 Weeks	0.00% 0/43 • 6 Weeks
Cardiac disorders Ectopic Beats	2.0% 1/49 • Number of events 1 • 6 Weeks	0.00% 0/43 • 6 Weeks
Skin and subcutaneous tissue disorders Cricopharyngeal Spasm	2.0% 1/49 • Number of events 1 • 6 Weeks	0.00% 0/43 • 6 Weeks

Additional Information

Clinical Research Scientist

Fisher & Paykel Healthcare

Phone: +6495740123

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place