CPAP In-home Assessment NZ

Not Applicable

Completed

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

• Registration Number: NCT02804919
• Lead Sponsor: Fisher and Paykel Healthcare

Brief 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.

Study Timeline

• Study First Submitted: 2016-06-15
• Study First Submitted QC: 2016-06-15
• Study First Posted: 2016-06-17
• Study Start: 2016-07
• Primary Completion: 2017-06-16
• Study Completion: 2017-06-16
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-01
• Last Update Posted: 2018-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Aged 18 and over
• Diagnosed with Obstructive Sleep Apnea (OSA) and prescribed Positive Airway Pressure (either Continuous positive airway pressure (CPAP) or AutoCPAP)
• Be fluent in spoken and written English

Exclusion Criteria

• Contraindicated for Positive Airway Pressure (CPAP or AutoCPAP) therapy
• Persons with other significant sleep disorder(s) (e.g periodic leg movements, insomnia, central sleep apnea)
• Persons with obesity hypoventilation syndrome or congestive heart failure
• Persons that require supplemental oxygen with their Positive Airway Pressure (CPAP or AutoCPAP) device.
• Persons with implanted electronic medical devices (e.g cardiac pacemakers)
• Persons who are pregnant or think they may be pregnant.

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 machine faults	6 months	Obtained from the device - Phase 1 and Phase 2 of the trial
Apnea Hypopnea Index (AHI), measured as number of events/hour hour.	6 months	Obtained from the device - Phase 1 and Phase 2 of the trial
Log of safety-related events, measured as number of safety-related faults	6 months	Obtained from the device - Phase 1 and Phase 2 of the trial
Participant reported faults, measured as number of participant complaints	6 months	Obtained from the follow up visits - Phase 1 and Phase 2 of the trial

Secondary Outcome Measures

Name	Time	Method
Perception of the device, measured through questionnaire	6 months	Impression of the device during the follow up visits - Phase 1 only

Trial Locations

Locations (1)

Fisher & Paykel Healthcare; 🇳🇿 Auckland, New Zealand