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OpenTrials
Completed

NCT Number: NCT02804919

CPAP In-home Assessment NZ

Phase 1: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.

Phase 2: To evaluate the CPAP device with communication functionality with data upload.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fisher & Paykel Healthcare

Auckland, 0600, New Zealand

About this study

Phase 1: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.

Phase 2: 10 participants from Phase 1 will be recruited to use the device for up to 6 month in-home. Participants will attend 3 study visits at day 0, 7 30. The trial may be extended to 60 days if longer term data is required.

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 Obstructive Sleep Apnea (OSA) and prescribed Positive Airway Pressure (either Continuous positive airway pressure (CPAP) or AutoCPAP)
  • Be fluent in spoken and written English

Exclusion criteria

  • Contraindicated for Positive Airway Pressure (CPAP or AutoCPAP) 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 Positive Airway Pressure (CPAP or AutoCPAP) device.
  • Persons with implanted electronic medical devices (e.g cardiac pacemakers)
  • Persons who are pregnant or think they may be pregnant.

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 hour.

    Time frame: 6 months

    Obtained from the device - Phase 1 and Phase 2 of the trial

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

    Time frame: 6 months

    Obtained from the device - Phase 1 and Phase 2 of the trial

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

    Time frame: 6 months

    Obtained from the device - Phase 1 and Phase 2 of the trial

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

    Time frame: 6 months

    Obtained from the follow up visits - Phase 1 and Phase 2 of the trial

Secondary outcomes

  1. Perception of the device, measured through questionnaire

    Time frame: 6 months

    Impression of the device during the follow up visits - Phase 1 only

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 17, 2016
Registry last updated
Aug 3, 2018

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.

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