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 @ 4:01 AM
Ignite Modification Date:
2025-12-25 @ 4:01 AM
NCT ID:
NCT06093802
Eligibility Criteria:
Inclusion Criteria:
* Surgically naïve, otherwise healthy, non-syndromic children aged 2-12 years with suspected oSDB of any severity
* One completed Pediatric Sleep Questionnaire - Sleep Related Breathing Disorder (PSQ)
* Home Respiratory Polygraphy (HRP) and/or in-house Polysomnography (PSG) showing OSA according to the definition of AAO-HNSF
Exclusion Criteria:
* Syndromes and congenital/acquired craniofacial abnormalities/malformations of the upper airways
* Neurological conditions affecting upper airway muscle tone
* Lower airway disease (tracheomalacia, asthma)
* Previous surgery of the nose/pharynx/larynx
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
12 Years
Study:
NCT06093802
Study Brief:
Protocol Section:
NCT06093802