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:
2025-12-26 @ 4:01 PM
Ignite Modification Date:
2025-12-26 @ 4:01 PM
NCT ID:
NCT00458406
Eligibility Criteria:
Inclusion Criteria:
1. Males or females aged 2 to 16 years.
2. OSAS diagnosed on polysomnography.
3. Positive airway pressure therapy indicated by patient's physician because surgery was either contraindicated or ineffective.
4. No plans for upper airway surgery in the next 3 months.
Exclusion Criteria:
1. Age less than 2 years, as infants and toddlers have different pulmonary mechanics from older children, and may require intense behavioral modification programs prior to CPAP use.
2. Age greater or equal to 16 years, as results may be similar to adult studies in these older patients.
3. Previous use of CPAP / bilevel ventilation.
4. Unable to read / understand English. -
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
16 Years
Study:
NCT00458406
Study Brief:
Protocol Section:
NCT00458406