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 @ 5:52 PM
Ignite Modification Date:
2025-12-24 @ 5:52 PM
NCT ID:
NCT07280468
Eligibility Criteria:
Inclusion Criteria:
1. Age 6 years or older
2. Down syndrome diagnosis
3. Any gender or ethnicity
4. Adults without a legally authorized representative must have a caregiver/support person that can co-sign consent and complete study questionnaires.
Exclusion Criteria:
1. Currently using and adherent to PAP therapy (\>4 hours per night for 70% of nights in the past 30 days based on device download or parent/caregiver report)
2. MAO inhibitor use
3. Urinary retention
4. Seizure disorder
5. Untreated or inadequately treated hypothyroidism
6. Significant traumatic brain injury
7. Not cleared to participate in the study by their cardiologist for individuals with congenital heart disease requiring follow up with cardiology at least once in the past year
8. History of current, untreated depression
9. History of liver disease (not including metabolic dysfunction-associated steatotic liver disease)
10. 3+ or greater tonsillar hypertrophy (for children only, no restriction for adults)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Study:
NCT07280468
Study Brief:
Protocol Section:
NCT07280468