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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02809794
Other study ID # CIA175
Secondary ID
Status Completed
Phase N/A
First received June 19, 2016
Last updated June 26, 2017
Start date July 2016
Est. completion date March 2017

Study information

Verified date June 2017
Source Fisher and Paykel Healthcare
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date March 2017
Est. primary completion date March 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Device:
Fisher & Paykel Healthcare CPAP Device
Fisher & Paykel Healthcare CPAP Device

Locations

Country Name City State
Australia Sleep Matters Bulleen Victoria
Australia Sleep & Snore Solutions Bunbury Western Australia
Australia St John of God Midland Public Hospital Midland Western Australia

Sponsors (1)

Lead Sponsor Collaborator
Fisher and Paykel Healthcare

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Apnea Hypopnea Index (AHI), measured as number of events/hour Obtained from the device 6 months
Primary Log of safety-related events, measured as number of safety-related faults Obtained from the device 6 months
Primary Machine reported faults, measured as number of machine faults Obtained from the device 6 months
Primary Participant reported faults, measured as number of participant complaints Obtained from the follow up visits 6 months
Secondary Perception of the device, measured through questionnaire Impression of the device during the follow up visits 6 months
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