Status:
COMPLETED
Comparison Study of the ICON™ CPAP Series With and Without SensAwake™
Lead Sponsor:
Fisher and Paykel Healthcare
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Conceptually, awareness of pressure occurs only during wakefulness. Thus reducing the pressure during wakefulness may improve therapy comfort and potentially adherence without compromizing therapy eff...
Eligibility Criteria
Inclusion
- Aged 18-75 years with moderate-to-severe OSA (AHI equal to or greater than 10 per hour).
- Successful in-lab titration polysomnography (PSG)
- General (at home) sleep habits of:
- At least 7 hours in bed on most nights
- Lights out at 12 midnight or earlier
- 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.
- Patients who are prescribed hypnotics and sedating medications.
- Any surgery of the mouth, nose, sinuses or airways (for OSA, snoring or otherwise) in the past 12 months.
- 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 :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT01831258
Start Date
March 1 2013
End Date
September 1 2014
Last Update
July 19 2017
Active Locations (3)
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1
Pulmonary Associates
Glendale, Arizona, United States, 85306
2
SleepMed of Central Georgia
Macon, Georgia, United States
3
Sleep Med of South Carolina
Columbia, South Carolina, United States