Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 12:04 AM
NCT ID:
NCT01831258
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01831258
Study Brief:
Protocol Section:
NCT01831258