CPAP In-home Assessment Australia

Fisher and Paykel Healthcare50 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Obstructive Sleep Apnea

Interventions

Fisher & Paykel Healthcare CPAP DeviceDEVICE

Fisher \& Paykel Healthcare CPAP Device

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Sleep Matters

Bulleen, Victoria, Australia

Sleep & Snore Solutions

Bunbury, Western Australia, Australia

St John of God Midland Public Hospital

Midland, Western Australia, Australia

Outcomes

Primary Outcomes

Apnea Hypopnea Index (AHI), measured as number of events/hour

Obtained from the device

Time frame: 6 months

Log of safety-related events, measured as number of safety-related faults

Obtained from the device

Time frame: 6 months

Machine reported faults, measured as number of machine faults

Obtained from the device

Time frame: 6 months

Participant reported faults, measured as number of participant complaints

Obtained from the follow up visits

Time frame: 6 months

Secondary Outcomes

Perception of the device, measured through questionnaire

Impression of the device during the follow up visits

Time frame: 6 months

Data from ClinicalTrials.gov

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