Back to resultsCPAP In-home Assessment NZ
Primary Purpose
Obstructive Sleep Apnea
Status
Completed
Phase
Not Applicable
Locations
New Zealand
Study Type
Interventional
Intervention
Fisher & Paykel Healthcare CPAP Device
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea
Eligibility 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.
Sites / Locations
- Fisher & Paykel Healthcare
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Investigational CPAP device
Arm Description
Fisher & Paykel Healthcare CPAP Device
Outcomes
Primary Outcome Measures
Apnea Hypopnea Index (AHI), measured as number of events/hour hour.
Obtained from the device - Phase 1 and Phase 2 of the trial
Log of safety-related events, measured as number of safety-related faults
Obtained from the device - Phase 1 and Phase 2 of the trial
Machine reported faults, measured as number of machine faults
Obtained from the device - Phase 1 and Phase 2 of the trial
Participant reported faults, measured as number of participant complaints
Obtained from the follow up visits - Phase 1 and Phase 2 of the trial
Secondary Outcome Measures
Perception of the device, measured through questionnaire
Impression of the device during the follow up visits - Phase 1 only
Full Information
NCT ID
NCT02804919
First Posted
June 15, 2016
Last Updated
August 1, 2018
Sponsor
Fisher and Paykel Healthcare
1. Study Identification
Unique Protocol Identification Number
NCT02804919
Brief Title
CPAP In-home Assessment NZ
Official Title
CPAP In-home Assessment NZ
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
July 2016 (undefined)
Primary Completion Date
June 16, 2017 (Actual)
Study Completion Date
June 16, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fisher and Paykel Healthcare
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Investigational CPAP device
Arm Type
Experimental
Arm Description
Fisher & Paykel Healthcare CPAP Device
Intervention Type
Device
Intervention Name(s)
Fisher & Paykel Healthcare CPAP Device
Intervention Description
Fisher & Paykel Healthcare CPAP Device
Primary Outcome Measure Information:
Title
Apnea Hypopnea Index (AHI), measured as number of events/hour hour.
Description
Obtained from the device - Phase 1 and Phase 2 of the trial
Time Frame
6 months
Title
Log of safety-related events, measured as number of safety-related faults
Description
Obtained from the device - Phase 1 and Phase 2 of the trial
Time Frame
6 months
Title
Machine reported faults, measured as number of machine faults
Description
Obtained from the device - Phase 1 and Phase 2 of the trial
Time Frame
6 months
Title
Participant reported faults, measured as number of participant complaints
Description
Obtained from the follow up visits - Phase 1 and Phase 2 of the trial
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Perception of the device, measured through questionnaire
Description
Impression of the device during the follow up visits - Phase 1 only
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Irene Cheung, MSc/RPSGT
Organizational Affiliation
Fisher & Paykel Healthcare
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fisher & Paykel Healthcare
City
Auckland
ZIP/Postal Code
0600
Country
New Zealand
12. IPD Sharing Statement
Learn more about this trial
CPAP In-home Assessment NZ
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