CPAP In-home Assessment Australia

Not Applicable

Completed

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

• Registration Number: NCT02809794
• 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: 2017-03
• Study Completion: 2017-03
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-26
• Last Update Posted: 2017-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Aged 18 and over.
• Diagnosed with OSA by a practicing physician and prescribed Positive Airway Pressure (PAP) therapy.

Exclusion Criteria

• Persons contraindicated for Continuous Positive Airway Pressure (CPAP) 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 CPAP device.
• Persons with implanted electronic medical devices (e.g. cardiac pacemakers).
• Persons who are pregnant or think they might be pregnant.
• Persons whose primary language is other than English.
• Persons in existing dependent or unequal relationships with any member of the research team, the researcher(s) and/or the person undertaking the recruitment/consent process.
• Persons highly dependent on medical care.
• People with cognitive impairment, an intellectual disability or a mental illness

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

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Sleep Matters; 🇦🇺 Bulleen, Victoria, Australia

St John of God Midland Public Hospital; 🇦🇺 Midland, Western Australia, Australia

Sleep & Snore Solutions; 🇦🇺 Bunbury, Western Australia, Australia