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 @ 4:31 AM
Ignite Modification Date:
2025-12-25 @ 4:31 AM
NCT ID:
NCT03188718
Eligibility Criteria:
Inclusion Criteria:
1. Age 5 through 12 years of age.
2. Referral to the Sleep Lab due to concerns for Obstructive Sleep Apnea (OSA) and presenting with symptoms such as:
* snoring,
* witnessed apneas,
* daytime sleepiness, and
* mouth breathing, etc.
3. Informed consent obtained.
Exclusion Criteria:
1. Medical conditions that can affect the tonometer reading such as:
* peripheral vascular disease,
* cyanotic heart disease,
* systemic hypertension, and
* sickle cell crisis.
2. Medical conditions that can potentially limit tolerance of the WatchPAT 200 device such as:
* autism spectrum disorder,
* Trisomy 21, and
* neurodevelopmental disorders.
3. History of neuromuscular malformation
4. History of current supplemental oxygen use
5. History of current vasoactive, cardiac or seizure medication use
6. Inability or unwillingness to provide informed consent
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
12 Years
Study:
NCT03188718
Study Brief:
Protocol Section:
NCT03188718