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CPAP In-home Assessment Australia

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ClinicalTrials.gov Identifier: NCT02809794
Recruitment Status : Completed
First Posted : June 22, 2016
Last Update Posted : June 27, 2017
Sponsor:
Information provided by (Responsible Party):
Fisher and Paykel Healthcare

Brief 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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Device: Fisher & Paykel Healthcare CPAP Device Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CPAP In-home Assessment Australia
Study Start Date : July 2016
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Investigational CPAP device
Fisher & Paykel Healthcare CPAP Device
Device: Fisher & Paykel Healthcare CPAP Device
Fisher & Paykel Healthcare CPAP Device




Primary Outcome Measures :
  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 Outcome Measures :
  1. Perception of the device, measured through questionnaire [ Time Frame: 6 months ]
    Impression of the device during the follow up visits



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02809794


Locations
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Australia, Victoria
Sleep Matters
Bulleen, Victoria, Australia, 3105
Australia, Western Australia
Sleep & Snore Solutions
Bunbury, Western Australia, Australia, 6230
St John of God Midland Public Hospital
Midland, Western Australia, Australia, 6056
Sponsors and Collaborators
Fisher and Paykel Healthcare

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Responsible Party: Fisher and Paykel Healthcare
ClinicalTrials.gov Identifier: NCT02809794     History of Changes
Other Study ID Numbers: CIA175
First Posted: June 22, 2016    Key Record Dates
Last Update Posted: June 27, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
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Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases