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 @ 1:08 AM
Ignite Modification Date:
2025-12-25 @ 1:08 AM
NCT ID:
NCT06556693
Eligibility Criteria:
Inclusion Criteria:
* Severe sleep disordered breathing
* Expected to tolerate study procedures
* No heart failure or medically stable heart failure
Exclusion Criteria:
* Currently implanted with a neurostimulator to treat sleep disordered breathing without sponsor approval
* History of severe COPD or pulmonary arterial hypertension
* Current or previous history of nerve injury or palsy
* Prior cervical surgeries or radiation treatment to head region
* Known need for an MRI
* History of psychosis or severe bipolar disorder
* Active Infection or sepsis within 30 days of enrollment
* Currently on kidney dialysis or significantly reduced kidney function
* Hemoglobin less than 8g/dl
* Pacemaker dependance
* New defibrillator or any implantable device or device generator changeout within 30 days prior to study implant or anticipated within the first 12 months
* Other conditions or anticipated surgical procedure expected to affect ability to complete study procedures
* Allergy to contrast dye unless can be prophylactically treated
* Known pregnancy or planning to become pregnant
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Study:
NCT06556693
Study Brief:
Protocol Section:
NCT06556693