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 @ 2:32 AM
Ignite Modification Date:
2025-12-25 @ 2:32 AM
NCT ID:
NCT03219034
Eligibility Criteria:
Inclusion Criteria:
* OSA PSG or PG diagnosed adults within 1 year
* age \>18
* Currently treated with continuous positive airway pressure (CPAP)
* AHI ≥ \>30 events/hour of sleep
* Two or more OSA symptoms (snoring, witnessed apnea or daytime hypersomnolence complaint)
* BMI ≥ 30
* At least 8 teeth per arch to support either OA device
* Central and mixed apnea index \<5 events/hour
* Mallampati score from I to III
* Palatine tonsils - grade 0, 1, or 2
* Consent to study's timeline
* Willingness to wear home sleep test apparatus for at least 4 nights
* Willingness to wear an oral appliance every night for 8 weeks
* Willingness to pick up and return home sleep test kits as needed
Exclusion Criteria:
* Cardiac \& pulmonary disease (e.g., congestive heart failure, severe arrhythmias, COPD);
* Central sleep apnea;
* Comorbidities with other sleep disorders
* No active TMD or jaw muscle pain
* Morphological airway abnormalities
* Pre-existing difficulty swallowing; throat or neck related health issues
* Endocrine dysfunction
* Severe psychiatric disorders;
* Previous OA therapy; ENT surgery
* Restrictions in jaw opening
* Pregnancy / breast feeding or intent to become pregnant during the study
* Inability to apply the sleep recorders
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03219034
Study Brief:
Protocol Section:
NCT03219034