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CPAP In-home Assessment NZ

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02804919
Recruitment Status : Completed
First Posted : June 17, 2016
Last Update Posted : August 3, 2018
Sponsor:
Information provided by (Responsible Party):
Fisher and Paykel Healthcare

Brief Summary:

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.


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

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CPAP In-home Assessment NZ
Study Start Date : July 2016
Actual Primary Completion Date : June 16, 2017
Actual Study Completion Date : June 16, 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 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 Outcome Measures :
  1. Perception of the device, measured through questionnaire [ Time Frame: 6 months ]
    Impression of the device during the follow up visits - Phase 1 only



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 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.

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): NCT02804919


Locations
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New Zealand
Fisher & Paykel Healthcare
Auckland, New Zealand, 0600
Sponsors and Collaborators
Fisher and Paykel Healthcare
Investigators
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Principal Investigator: Irene Cheung, MSc/RPSGT Fisher & Paykel Healthcare
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Responsible Party: Fisher and Paykel Healthcare
ClinicalTrials.gov Identifier: NCT02804919    
Other Study ID Numbers: CIA174
First Posted: June 17, 2016    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: August 2018
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