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:
2025-12-24 @ 6:58 PM
Ignite Modification Date:
2025-12-24 @ 6:58 PM
NCT ID:
NCT02261857
Eligibility Criteria:
Inclusion Criteria:
* On-going need for CPAP therapy based on polysomnography
* Inability to tolerate CPAP attributed to poor fit by a sleep clinician
* The opinion of a sleep clinician that reasonable commercially available mask options have been exhausted
* Caregivers must also be proficient in English to complete standard questionnaires.
Exclusion Criteria:
* Subjects no longer needing CPAP therapy
* Subjects able to successfully use a commercially available mask.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
18 Years
Study:
NCT02261857
Study Brief:
Protocol Section:
NCT02261857