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 @ 6:50 PM
Ignite Modification Date:
2025-12-24 @ 6:50 PM
NCT ID:
NCT00307957
Eligibility Criteria:
Inclusion Criteria:
* 18 years or older
* Body Mass Index equal to 32 or less
* Apnea-Hypopnea Index greater than/equal to 10 and less than/equal to 30
* Symptoms of daytime sleepiness
Exclusion Criteria:
* Septal deviation or nasal obstruction
* Nasal polyps
* Severe seasonal allergies
* Soft palate length insufficient to accommodate implants
* Fujita Modified Mallampati Class 3
* Large tonsils
* Lingual tonsil hypertrophy
* Hypopharyngeal obstruction
* Previous pharyngeal surgery
* Previous upper respiratory tract cancer or radiation therapy
* Active respiratory tract infection
* Dysphagia or speech disorder
* Neurologic disorder
* Unstable psychiatric disorder
* Pregnant or breastfeeding
* History of falling asleep driving or MVA due to sleepiness
* Currently on CPAP therapy or other device for OSA
* Other sleep disorders
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00307957
Study Brief:
Protocol Section:
NCT00307957