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 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 1:18 AM
NCT ID:
NCT00607893
Eligibility Criteria:
Inclusion Criteria:
* Moderate to severe sleep disordered breathing (SDB) (Apnea Hypopnea Index \[AHI\] greater than or equal to 15) diagnosed within the 2 months before study entry
* Able to participate in more than two overnight/daytime sleep and physiologic assessments over a 2.5-month period
Exclusion Criteria:
* Current or planned use of specific sleep apnea treatments (e.g., CPAP, oral appliance) outside of the study
* Anticipated upper airway surgery or gastric bypass surgery in the 4 months after study completion
* Supplemental oxygen use
* Primary sleep disorder other than sleep apnea (e.g., periodic limb movement disorder)
* Severe chronic insomnia or circadian rhythm disorder with less than 4 hours of sleep per night, chronic problems falling asleep within 1 hour of bedtime, or chronic problems with early morning awakenings
* Unstable medical conditions (e.g., new onset or changing angina; heart attack or congestive heart failure exacerbation documented within the 6 months before study entry; high grade cardiac dysrhythmia/heart block; known unaddressed coronary artery disease by history, angina, stroke, or uncontrolled hypertension or diabetes mellitus; thyroid disorder; cirrhosis; a non-skin cancer diagnosed within the 2 years before study entry)
* Inadequately treated psychiatric disorders or compromised competence
* Daytime sleepiness with reports of sleepiness while driving or during other situations that would present a risk for the subject or public (e.g., operating heavy equipment)
* Alcohol abuse
* Pregnancy
* Use of oral corticosteroids
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
75 Years
Study:
NCT00607893
Study Brief:
Protocol Section:
NCT00607893