CPAP In-home Assessment USA

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Device: Fisher & Paykel Healthcare CPAP Device

• Registration Number: NCT02809859
• Lead Sponsor: Fisher and Paykel Healthcare

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2016-06-19
• Study First Submitted QC: 2016-06-19
• Study First Posted: 2016-06-22
• Study Start: 2016-07
• Primary Completion: 2017-04
• Study Completion: 2017-04
• Results First Submitted: 2018-10-08
• Status Verified: 2019-02
• Results First Submitted QC: 2019-02-12
• Last Update Submitted: 2019-02-12
• Results First Posted: 2019-03-05
• Last Update Posted: 2019-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 139

Inclusion Criteria

• Aged 22 and over
• Diagnosed with Obstructive Sleep Apnea (OSA) and prescribed Positive Airway Pressure (either Continuous positive airway pressure (CPAP) or AutoCPAP)
• For experienced users of PAP (CPAP or AutoCPAP) - you must be using PAP of more than 4 hours/night for 70% during the last 30 days.

Exclusion Criteria

• Contraindicated for PAP (CPAP or AutoCPAP) therapy
• Has other significant sleep disorders (e.g periodic leg movements, insomnia, central sleep apnea)
• Has obesity hypoventilation syndrome or congestive heart failure
• Requires supplemental oxygen with their PAP (CPAP or AutoCPAP) device
• Has implanted electronic medical devices (e.g cardiac pacemakers)
• Pregnant or think they may be pregnant
• Not fluent in spoken and written English.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Investigational CPAP device	Fisher & Paykel Healthcare CPAP Device	Fisher \& Paykel Healthcare CPAP Device

Primary Outcome Measures

Name	Time	Method
Machine Reported Faults, Measured as Number of Patients With Machine Faults	6 months
Log of Safety Related Events, Measured as Number of Participants That Experienced Unacceptable Safety Related Faults	6 months
Apnea Hypopnea Index (AHI), Measured as Number of Events/Hour.	6 months
Participant Reported Faults, Measured as Number of Participant Complaints	6 months

Secondary Outcome Measures

Name	Time	Method
How Many Participants Slept Acceptably, Well or Very Well Throughout the Night on the CPAP Device	6 months

Trial Locations

Locations (4)

Alabama Sleep Clinic; 🇺🇸 Huntsville, Alabama, United States

Pulmonary Disease Specialists - Central Florida Sleep Centre; 🇺🇸 Kissimmee, Florida, United States

Clayton Sleep Institute; 🇺🇸 Saint Louis, Missouri, United States

Ohio Sleep Medicine and Neurosciences Institute; 🇺🇸 Dublin, Ohio, United States