CPAP In-home Assessment USA
1 other identifier
interventional
139
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2016
Shorter than P25 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 19, 2016
CompletedFirst Posted
Study publicly available on registry
June 22, 2016
CompletedStudy Start
First participant enrolled
July 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2017
CompletedResults Posted
Study results publicly available
March 5, 2019
CompletedMarch 5, 2019
February 1, 2019
9 months
June 19, 2016
October 8, 2018
February 12, 2019
Conditions
Outcome Measures
Primary Outcomes (4)
Apnea Hypopnea Index (AHI), Measured as Number of Events/Hour.
6 months
Log of Safety Related Events, Measured as Number of Participants That Experienced Unacceptable Safety Related Faults
6 months
Machine Reported Faults, Measured as Number of Patients With Machine Faults
6 months
Participant Reported Faults, Measured as Number of Participant Complaints
6 months
Secondary Outcomes (1)
How Many Participants Slept Acceptably, Well or Very Well Throughout the Night on the CPAP Device
6 months
Study Arms (1)
Investigational CPAP device
EXPERIMENTALFisher \& Paykel Healthcare CPAP Device
Interventions
Fisher \& Paykel Healthcare CPAP Device
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Alabama Sleep Clinic
Huntsville, Alabama, 35801, United States
Pulmonary Disease Specialists - Central Florida Sleep Centre
Kissimmee, Florida, 34741, United States
Clayton Sleep Institute
St Louis, Missouri, 63143, United States
Ohio Sleep Medicine and Neurosciences Institute
Dublin, Ohio, 43017, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Research Scientist
- Organization
- Fisher & Paykel Healthcare
Study Officials
- PRINCIPAL INVESTIGATOR
Matt Uhles
Clayton Sleep Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 19, 2016
First Posted
June 22, 2016
Study Start
July 1, 2016
Primary Completion
April 1, 2017
Study Completion
April 1, 2017
Last Updated
March 5, 2019
Results First Posted
March 5, 2019
Record last verified: 2019-02