NCT02804919

CPAP In-home Assessment NZ

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Fisher and Paykel Healthcare · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase 1:The study is to evaluate the product reliability, therapy effectiveness and user feedback of a Continuous Positive Airway Pressure (CPAP) device in-home for up to 6 months. Phase 2: To evaluate the CPAP device with communication functionality with data upload.

Detailed description

Phase 1:Existing and Naïve CPAP users will be recruited into a 6 month in-home study Participants will attend 5 study visits at day 0, 7, 30, 60 and 180. Outcome of the clinical investigation include downloadable device data reports, device error reports and participants perception questionnaires. Phase 2: 10 participants from Phase 1 will be recruited to use the device for up to 6 month in-home. Participants will attend 3 study visits at day 0, 7 30. The trial may be extended to 60 days if longer term data is required.

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DEVICE	Fisher & Paykel Healthcare CPAP Device	Fisher \& Paykel Healthcare CPAP Device

Timeline

• Start date: 2016-07-01
• Primary completion: 2017-06-16
• Completion: 2017-06-16
• First posted: 2016-06-17
• Last updated: 2018-08-03

Locations

1 site across 1 country: New Zealand