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 @ 9:30 PM
Ignite Modification Date:
2025-12-24 @ 9:30 PM
NCT ID:
NCT05350332
Eligibility Criteria:
Inclusion Criteria:
* Adult patients (≥ 18 yrs) willing and capable of providing informed consent
* Obstructive sleep apnea (AHI ≥ 5 events/hour)
* Must be willing and able to provide informed consent to participate in the study.
* Interested in surgical treatments of OSA and have consented for a DISE procedure as part of their routine clinical evaluation.
* Patients are evaluated and cleared by anesthesia prior to the procedure.
Exclusion Criteria:
* No significant uncontrolled medical co-morbidities (e.g., uncontrolled hypertension, unstable angina, uncompensated heart failure or COPD).
* Any medical comorbidity that would prevent the patient from receiving anesthesia or having surgery
* Inability to tolerate negative pressure ventilator or perform PFT (i.e. claustrophobia)
* No incapacitating disability that interferes with execution of the protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05350332
Study Brief:
Protocol Section:
NCT05350332