NCT02948010

CPAP Device In-lab Assessment NZ

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: Fisher and Paykel Healthcare · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this trial is to assess device performance against participants in an overnight study to ensure the product meets user and clinical requirements

Detailed description

Existing Adult Continuous Positive Airway Pressure (CPAP) therapy users will be recruited for an overnight polysomnography (PSG) sleep study. The participants will use the investigational CPAP device and be connected to a PSG during their session. The device performance during the session will be assessed. Outcomes of the clinical investigation include downloadable device data reports, device error reports and participants perception questionnaires and PSG data.

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DEVICE	Auto CPAP + comfort feature A	Auto CPAP + comfort feature A using Fisher \& Paykel Healthcare CPAP Device
DEVICE	Auto CPAP with comfort feature B	Auto CPAP with comfort feature B using Fisher \& Paykel Healthcare CPAP Device
DEVICE	Auto CPAP with no comfort feature	Auto CPAP with no comfort feature using Fisher \& Paykel Healthcare CPAP Device
DEVICE	Auto CPAP with comfort feature A+B	Auto CPAP with comfort feature A+B using Fisher \& Paykel Healthcare CPAP Device
DEVICE	CPAP with comfort feature A	CPAP with comfort feature A using Fisher \& Paykel Healthcare CPAP Device
DEVICE	CPAP with comfort feature B	CPAP with comfort feature B using Fisher \& Paykel Healthcare CPAP Device
DEVICE	CPAP with no comfort feature	CPAP with no comfort feature using Fisher \& Paykel Healthcare CPAP Device
DEVICE	CPAP with comfort feature A + B	CPAP with comfort feature A + B using Fisher \& Paykel Healthcare CPAP Device
DEVICE	CPAP at Sub therapeutic level	CPAP at Sub therapeutic level using Fisher \& Paykel Healthcare CPAP Device

Timeline

• Start date: 2016-11-01
• Primary completion: 2017-03-01
• Completion: 2017-03-01
• First posted: 2016-10-28
• Last updated: 2017-06-27

Locations

1 site across 1 country: New Zealand