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 @ 11:30 PM
Ignite Modification Date:
2025-12-24 @ 11:30 PM
NCT ID:
NCT01336556
Eligibility Criteria:
Inclusion Criteria:
* Male subjects aged between 25 and 65 years old
* Epworth sleepiness Scale \> 9
* Apnea-hypopnea index between 5 and 30
Exclusion Criteria:
* Presence of clinical disease (chronic obstructive pulmonary disease, asthma) and other sleep disorders.
* Presence of anatomical obstructive upper airway, tonsil grade III e IV, septal deviation and grade III that may affect the outcome of CPAP
* Loss of posterior dental support to undermine the retention of oral appliance
* Active of periodontal disease, compared Dental crow/dental root less than or equal to 1 (c/r ≤ 1) need primary dental care (cavities, root canal treatment or retreatment, dentures, i.e. outlying), open bite
* Protrusive displacement lass then five millimeters
* Limited mouth opening
* Alcoholism
* Use of sleep-inducing medications
* Habits or occupation that lead to sleep deprivation or alteration of the sleep-wake cycle
* Intolerance to CPAP
* Obesity grade II (moderate) or III (severe)
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
25 Years
Maximum Age:
65 Years
Study:
NCT01336556
Study Brief:
Protocol Section:
NCT01336556