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 @ 4:29 AM
Ignite Modification Date:
2025-12-25 @ 4:29 AM
NCT ID:
NCT01161420
Eligibility Criteria:
Inclusion Criteria:
* Likely suffer moderate-to-severe OSA based on history and physical
* Have failed or have not tolerated CPAP treatment
* Willing and capable of providing informed consent
* Willing and capable to have stimulation hardware permanently implanted, and to use the patient programmer to activate the stimulation
* Willing and capable to return for all follow-up visits and sleep studies, including the evaluation procedures and filling out the questionnaires
Exclusion Criteria:
* Body Mass Index limits
* Surgical resection or radiation therapy for cancer or congenital malformations in the larynx, tongue, or throat
* Significant co-morbidities making the patient unable or inappropriate to participate in the trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Study:
NCT01161420
Study Brief:
Protocol Section:
NCT01161420