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CompletedNCT02809794Updated Jun 27, 2017

CPAP In-home Assessment Australia

An interventional study of Fisher & Paykel Healthcare CPAP Device in Obstructive Sleep Apnea, sponsored by Fisher and Paykel Healthcare. Completed at 3 sites in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-06-27.

Sponsored by Fisher and Paykel Healthcare · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Obstructive Sleep Apnea
03

In context

Sleep Apnea, Obstructive

2,198 studies on the registry are indexed under Sleep Apnea, Obstructive; 469 are open to participants now.

This study's enrollment of 50 is close to the median of 53 across 1,448 interventional studies indexed under Sleep Apnea, Obstructive.

Browse Sleep Apnea, Obstructive studies →

Lead sponsor

Fisher and Paykel Healthcare is the lead sponsor of 84 studies on the registry; 15 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 10 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Aged 18 and over.
  • Diagnosed with OSA by a practicing physician and prescribed Positive Airway Pressure (PAP) therapy.

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Investigational CPAP device

    Fisher \& Paykel Healthcare CPAP Device

    Device: Fisher & Paykel Healthcare CPAP Device

Interventions

  • DeviceFisher & Paykel Healthcare CPAP Device

    Fisher \& Paykel Healthcare CPAP Device

06

What researchers measure

Primary outcomes

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

    Obtained from the device

    Time frame: 6 months

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

    Obtained from the device

    Time frame: 6 months

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

    Obtained from the device

    Time frame: 6 months

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

    Obtained from the follow up visits

    Time frame: 6 months

Secondary outcomes

  1. Perception of the device, measured through questionnaire

    Impression of the device during the follow up visits

    Time frame: 6 months

07

Study locations

3 sites
  • Sleep Matters
    Bulleen, Victoria 3105, Australia
  • Sleep & Snore Solutions
    Bunbury, Western Australia 6230, Australia
  • St John of God Midland Public Hospital
    Midland, Western Australia 6056, Australia
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 27, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02809794
Lead sponsor
Fisher and Paykel Healthcare
Responsible party
Sponsor
First posted
Jun 22, 2016
Start date
Jul 2016
Primary completion
Mar 2017
Completion
Mar 2017
Last update
Jun 27, 2017

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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