Skip to main content
OpenTrials
Completed

NCT Number: NCT02809794

CPAP In-home Assessment Australia

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sleep Matters, Bulleen, Victoria, Australia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fisher & Paykel Healthcare CPAP Device

Device

Fisher & Paykel Healthcare CPAP Device

Primary outcomes

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

    Time frame: 6 months

    Obtained from the device

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

    Time frame: 6 months

    Obtained from the device

  3. Machine reported faults, measured as number of machine faults

    Time frame: 6 months

    Obtained from the device

  4. Participant reported faults, measured as number of participant complaints

    Time frame: 6 months

    Obtained from the follow up visits

Secondary outcomes

  1. Perception of the device, measured through questionnaire

    Time frame: 6 months

    Impression of the device during the follow up visits

Sponsors and collaborators

Lead sponsor

Fisher and Paykel Healthcare

Industry

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 22, 2016
Registry last updated
Jun 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.