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 @ 3:29 PM
Ignite Modification Date:
2025-12-24 @ 3:29 PM
NCT ID:
NCT01289392
Eligibility Criteria:
Inclusion Criteria:
* Male subjects aged between 25 and 65 years old
* Sedentary according to the criteria of Godin and Shephard (1985) and / or ACSM (2000)
* Epworth Sleepiness Scale over score of nine
* Normal range of laboratory tests \[blood count, cholesterol, High-density lipoprotein (HDL), triglycerides, fasting glucose, creatinine, Thyroid-stimulating hormone (TSH)\]
* Lung function test (spirometry), chest X-ray (for smokers and former smokers) electrocardiogram (rest and stress) and ENT examination without significant changes
Exclusion Criteria:
* Presence of clinical diseases (chronic obstructive pulmonary disease, asthma, interstitial lung diseases, neuromuscular diseases, heart failure, thyroid disease, rheumatologic and psychiatric) and other sleep disorders
* Presence of anatomical obstructive upper airway, tonsil grade III and IV septal deviation and grade III (severe) that may affect the outcome of CPAP
* Loss of posterior dental support to undermine the retention of oral appliance
* Active periodontal disease, compared Dental crown / dental root less than or equal to 1 (c / r ≤ 1), need for primary dental care (cavities, root canal treatment or retreatment, dentures, ie outlying), open bite
* Protrusive displacement less than five millimeters
* Limited mouth opening (would prevent the forming of the dental arches)
* Alcoholism
* Uuse of sleep-inducing medications
* Habits or occupations that lead to sleep deprivation or alteration of the sleep-wake cycle
* Inability to perform physical exercise, regular history sports activities
* Intolerance to Continuous Positive Airway Pressure (CPAP)
* Obesity grade II (moderate) and III (severe)
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
25 Years
Maximum Age:
65 Years
Study:
NCT01289392
Study Brief:
Protocol Section:
NCT01289392