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 @ 4:33 AM
Ignite Modification Date:
2025-12-25 @ 4:33 AM
NCT ID:
NCT06453018
Eligibility Criteria:
Inclusion Criteria:
1. Age 6-17 years
2. Diagnosis of positional OSA on a baseline diagnostic polysomnography (PSG), defined as 1) an overall OAHI ≥ 5 events/hour (moderate-to-severe OSA), 2) a supine OAHI greater than or equal to two times of the non-supine OAHI, and 3) at least 30 minutes or 10% of total sleep time of supine sleep, and at least 30 minutes or 10% of total sleep time of non-supine sleep observed in the diagnostic PSG (9-11)
3. Informed consent from a parent or a legal guardian
Exclusion Criteria:
1. Severe OSA with an OAHI ≥ 30 events/hour that conventional treatment such as adenotonsillectomy and CPAP should be considered before positional therapy, severe disease warranting urgent referral for treatment
2. Genetic, syndromal, or metabolic disease
3. Congenital or acquired neuromuscular disease
4. Craniofacial abnormalities
5. Structural or congenital heart disease
6. Severe chronic respiratory disease that may affect the oxygen saturation or ventilation during sleep and positional therapy is regarded as not appropriate
7. Autism spectrum disorder or severe developmental delay (developmental or functional age \<66% of chronological age (16) that could affect the tolerance to the positional device
8. Current treatment with positive airway pressure
9. Skeletal abnormalities or other conditions that restrict the sleeping position
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
17 Years
Study:
NCT06453018
Study Brief:
Protocol Section:
NCT06453018