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 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 12:22 AM
NCT ID:
NCT00380458
Eligibility Criteria:
Inclusion Criteria:
* Subject is \> or = 18 years of age
* Subject has positive diagnosis of Obstructive Sleep Apnea confirmed by polysomnographic study
* Subject is a surgical candidate for UPPP and tonsillectomy with or without tongue base somnoplasty
* Subject signs IRB-approved informed consent form
* Subject is willing and able to complete required follow-up.
Exclusion Criteria:
* Subject has had a previous tonsillectomy
* Subject's RDI \>40
* Subject has a history of chronic use of narcotic pain medications
* Subject is unable to take liquid opioid analgesics
* Subject requires additional surgical procedures (such as nasal septoplasty or FESS) within 28 days of enrollment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00380458
Study Brief:
Protocol Section:
NCT00380458