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 @ 3:33 AM
Ignite Modification Date:
2025-12-25 @ 3:33 AM
NCT ID:
NCT00358605
Eligibility Criteria:
Inclusion Criteria:
* stable on C-PAP for at least 3 months, and
* Previous diagnostic polysomnography ithin 2 years, and
* Pre-treatment AHI 10-30 ( mild-moderate sleep apnea), and
* Compliance \> 4hrs per night, and
* are willing and able to give informed consent
Exclusion Criteria:
* AHI \>30, or
* Oxygen Saturation \< 85% for \> 10% of study time during previous diagnostic PSG;
* Or less than 8 teeth per jaw;
* Or not enough teeth in good periodontal health to allow retention of the appliance;
* Clinical evidence of severe tempero-mandibular joint dysfunction;
* Operates heavy machinery or motor vehicle as part of job;
* previous Motor Vehicle Crash assoc. with sleepiness;
* or major cardiovascular morbidity;
* or medically complicated or medically unstable.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00358605
Study Brief:
Protocol Section:
NCT00358605