This trial is active, not recruiting.

Condition obstructive sleep apnea
Treatment fisher & paykel healthcare cpap device
Sponsor Fisher and Paykel Healthcare
Start date July 2016
End date March 2017
Trial size 50 participants
Trial identifier NCT02809794, CIA175


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Fisher & Paykel Healthcare CPAP Device
fisher & paykel healthcare cpap device
Fisher & Paykel Healthcare CPAP Device

Primary Outcomes

Apnea Hypopnea Index (AHI), measured as number of events/hour
time frame: 6 months
Log of safety-related events, measured as number of safety-related faults
time frame: 6 months
Machine reported faults, measured as number of machine faults
time frame: 6 months
Participant reported faults, measured as number of participant complaints
time frame: 6 months

Secondary Outcomes

Perception of the device, measured through questionnaire
time frame: 6 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title CPAP In-home Assessment Australia
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Fisher and Paykel Healthcare.