Back to resultsCPAP In-home Assessment Australia
Primary Purpose
Obstructive Sleep Apnea
Status
Completed
Phase
Not Applicable
Locations
Australia
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 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
Sites / Locations
- Sleep Matters
- Sleep & Snore Solutions
- St John of God Midland Public Hospital
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
Obtained from the device
Log of safety-related events, measured as number of safety-related faults
Obtained from the device
Machine reported faults, measured as number of machine faults
Obtained from the device
Participant reported faults, measured as number of participant complaints
Obtained from the follow up visits
Secondary Outcome Measures
Perception of the device, measured through questionnaire
Impression of the device during the follow up visits
Full Information
NCT ID
NCT02809794
First Posted
June 19, 2016
Last Updated
June 26, 2017
Sponsor
Fisher and Paykel Healthcare
1. Study Identification
Unique Protocol Identification Number
NCT02809794
Brief Title
CPAP In-home Assessment Australia
Official Title
CPAP In-home Assessment Australia
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
July 2016 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 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
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.
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.
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
50 (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
Description
Obtained from the device
Time Frame
6 months
Title
Log of safety-related events, measured as number of safety-related faults
Description
Obtained from the device
Time Frame
6 months
Title
Machine reported faults, measured as number of machine faults
Description
Obtained from the device
Time Frame
6 months
Title
Participant reported faults, measured as number of participant complaints
Description
Obtained from the follow up visits
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
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 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
Facility Information:
Facility Name
Sleep Matters
City
Bulleen
State/Province
Victoria
ZIP/Postal Code
3105
Country
Australia
Facility Name
Sleep & Snore Solutions
City
Bunbury
State/Province
Western Australia
ZIP/Postal Code
6230
Country
Australia
Facility Name
St John of God Midland Public Hospital
City
Midland
State/Province
Western Australia
ZIP/Postal Code
6056
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
CPAP In-home Assessment Australia
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