Back to resultsCPAP In-home Assessment USA
Primary Purpose
Obstructive Sleep Apnea
Status
Completed
Phase
Not Applicable
Locations
United States
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 22 and over
- Diagnosed with Obstructive Sleep Apnea (OSA) and prescribed Positive Airway Pressure (either Continuous positive airway pressure (CPAP) or AutoCPAP)
- For experienced users of PAP (CPAP or AutoCPAP) - you must be using PAP of more than 4 hours/night for 70% during the last 30 days.
Exclusion Criteria:
- Contraindicated for PAP (CPAP or AutoCPAP) therapy
- Has other significant sleep disorders (e.g periodic leg movements, insomnia, central sleep apnea)
- Has obesity hypoventilation syndrome or congestive heart failure
- Requires supplemental oxygen with their PAP (CPAP or AutoCPAP) device
- Has implanted electronic medical devices (e.g cardiac pacemakers)
- Pregnant or think they may be pregnant
- Not fluent in spoken and written English.
Sites / Locations
- Alabama Sleep Clinic
- Pulmonary Disease Specialists - Central Florida Sleep Centre
- Clayton Sleep Institute
- Ohio Sleep Medicine and Neurosciences Institute
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.
Log of Safety Related Events, Measured as Number of Participants That Experienced Unacceptable Safety Related Faults
Machine Reported Faults, Measured as Number of Patients With Machine Faults
Participant Reported Faults, Measured as Number of Participant Complaints
Secondary Outcome Measures
How Many Participants Slept Acceptably, Well or Very Well Throughout the Night on the CPAP Device
Full Information
NCT ID
NCT02809859
First Posted
June 19, 2016
Last Updated
February 12, 2019
Sponsor
Fisher and Paykel Healthcare
1. Study Identification
Unique Protocol Identification Number
NCT02809859
Brief Title
CPAP In-home Assessment USA
Official Title
CPAP In-home Assessment USA
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
July 2016 (undefined)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
April 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
139 (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.
Time Frame
6 months
Title
Log of Safety Related Events, Measured as Number of Participants That Experienced Unacceptable Safety Related Faults
Time Frame
6 months
Title
Machine Reported Faults, Measured as Number of Patients With Machine Faults
Time Frame
6 months
Title
Participant Reported Faults, Measured as Number of Participant Complaints
Time Frame
6 months
Secondary Outcome Measure Information:
Title
How Many Participants Slept Acceptably, Well or Very Well Throughout the Night on the CPAP Device
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged 22 and over
Diagnosed with Obstructive Sleep Apnea (OSA) and prescribed Positive Airway Pressure (either Continuous positive airway pressure (CPAP) or AutoCPAP)
For experienced users of PAP (CPAP or AutoCPAP) - you must be using PAP of more than 4 hours/night for 70% during the last 30 days.
Exclusion Criteria:
Contraindicated for PAP (CPAP or AutoCPAP) therapy
Has other significant sleep disorders (e.g periodic leg movements, insomnia, central sleep apnea)
Has obesity hypoventilation syndrome or congestive heart failure
Requires supplemental oxygen with their PAP (CPAP or AutoCPAP) device
Has implanted electronic medical devices (e.g cardiac pacemakers)
Pregnant or think they may be pregnant
Not fluent in spoken and written English.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matt Uhles
Organizational Affiliation
Clayton Sleep Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alabama Sleep Clinic
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Pulmonary Disease Specialists - Central Florida Sleep Centre
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Facility Name
Clayton Sleep Institute
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63143
Country
United States
Facility Name
Ohio Sleep Medicine and Neurosciences Institute
City
Dublin
State/Province
Ohio
ZIP/Postal Code
43017
Country
United States
12. IPD Sharing Statement
Learn more about this trial
CPAP In-home Assessment USA
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