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 @ 5:55 PM
Ignite Modification Date:
2025-12-24 @ 5:55 PM
NCT ID:
NCT01209468
Eligibility Criteria:
Inclusion Criteria:
* Aged 18 or older
* AHI ≥ 10-30/h, and those who do not tolerate CPAP or refused CPAP if AHI \>30
* A score of \> 10 on the Epworth Sleepiness Scale
* Body Mass Index \<35kg/m
* Those who are competent to give written informed consent
* have adequate dental anchoring structures (\<10 periodontally healthy teeth per arch)
Exclusion Criteria:
* Previous surgery to upper respiratory airway
* Concurrent unstable cardiovascular disease, neurological, mental or psychiatric disorders
* Recent major surgery in the last 6 months
* Pregnancy
* Epilepsy
* temporomandibular joint (TMJ) disfunction (pain during mandibular advancement or limitation of mouth opening)
* untreated dental decay
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01209468
Study Brief:
Protocol Section:
NCT01209468