Status:
TERMINATED
Comparison Study of the ICON™ Auto Series With and Without SensAwake™ and ThermoSmart™ and Conventional Continuous Positive Airway Pressure in Obstructive Sleep Apnea Patients
Lead Sponsor:
Fisher and Paykel Healthcare
Collaborating Sponsors:
Sleep Health Centers
Conditions:
Sleep Apnea, Obstructive
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
A total of 216 patients will be randomized into a partially single blind, randomized, parallel-arm trial to determine whether the ICON™ AT with SensAwake™ and ThermoSmart™ can improve therapy adherenc...
Eligibility Criteria
Inclusion
- Aged 18-70 years with moderate-to-severe OSA (Apnea Hypopnea Index equal to or greater than 10 per hour).
- Successful titration Polysomnography (PSG).
- Fluency in both written and spoken English.
Exclusion
- Participants prescribed and fitted with any PAP device in the past 2 years.
- Contraindicated for CPAP or AutoCPAP therapy.
- Any known factor or disease that might interfere with treatment adherence, study conduct or interpretation of the results such as severe psychiatric disease, history of non adherence to medical regimens, or unwillingness to comply with study requirements as determined by the principal investigator.
- Other significant sleep disorder(s) that would interfere with their ability to wear CPAP as determined by the principal investigator.
- Previous surgery for OSA or snoring or any surgery of the mouth, nose, sinuses or airways.
- If SensAwake™ or ThermoSmart™ was disabled on the treatment arm (or conversely) during the study protocol.
- If participants are required, by the nature of their employment, to comply with therapy. For example truck drivers or airline pilots.
- If the physician objects to their patient taking part in the study.
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01517763
Start Date
January 1 2012
End Date
September 1 2014
Last Update
June 10 2019
Active Locations (1)
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1
Sleep HealthCenters
Brighton, Massachusetts, United States, 02135