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 @ 1:32 PM
Ignite Modification Date:
2025-12-24 @ 1:32 PM
NCT ID:
NCT03844295
Eligibility Criteria:
Inclusion Criteria:
* Patient aged 18 to 80 years old
* Patient with moderate to severe OSA based on an established diagnosis of OSA (15≤AHI\<65) by polysomnography or respiratory polygraphy not older thant three years.
* Patient with moderate to severe OSA naïve of treatment or with difficulty accepting or adhering to CPAP treatment.
* 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 conduct sleep studies at home, including the evaluation procedures and filling out questionnaires
* Willing and capable of providing written informed consent.
Exclusion Criteria:
* Any anatomical finding that would compromise the performance of upper airway stimulation, such as the presence of complete concentric collapse of the soft palate
* Have any condition or procedure that has compromised neurological control of the upper airway
* Unable to operate the patient programmer
* Pregnant or plan to become pregnant, and breastfeeding women
* Require magnetic resonance imaging (MRI)
* Have an implantable device that may be susceptible to unintended interaction with the Inspire system.
Additional exclusions for study purposes only
* Body Mass Index (BMI) of \>32
* Central + mixed apneas \> 25% of the total apnea-hypopnea index (AHI)
* Neuromuscular disease
* Hypoglossal-nerve palsy
* Severe restrictive or obstructive pulmonary disease
* Moderate-to-severe pulmonary arterial hypertension
* Severe valvular heart disease
* New York Heart Association class III or IV heart failure
* Recent myocardial infarction or severe cardiac arrhythmias (within the past 6 months)
* Persistent uncontrolled hypertension despite medication use
* Coexisting nonrespiratory sleep disorders that would confound functional sleep assessment
* Any chronic medical illness or condition that contraindicates a surgical procedure under general anesthesia, as judged by the clinical study Investigator
* a terminal illness with life expectancy \< 12 months
* Active psychiatric disease (psychotic illness, major depression, or acute anxiety attacks) which prevents subject compliance with the requirements of the investigational study testing
* Radiotherapy or ablation therapy of the head and/or neck
* Surgical resection for cancer or congenital malformations in the larynx, tongue, or throat(with exception of tonsillectomy and/or adenoidectomy)
* Previous surgery within 3 months performed on the soft-palate tissue
* Obvious fixed upper airway obstructions (tumors, polyps, unilateral nasal obstruction)
* Need for chronic supplemental oxygen therapy for any other reason, pO2 (partial pressure of oxygen) \< 55 mm Hg
* Clinical evidence of severe renal failure (Stage 4 or 5) undergoing dialysis or expected to institute dialysis within 6 months
* Patients on medication that may alter consciousness, the pattern of respiration or sleep architecture (for example, benzodiazepiones, opiates, neuroleptics, prescription stimulants, phenothiazine, or any form of chemical substance abuse)
* Patients taking blood thinning medications (for example warfarin, aspirin, plavix or other blood thinning agents which cannot be safety stopped or bridged temporarily to allow surgery to take place)
* Any other reason for the investigator deems that the subject is unfit for participation in the study
* Subject in exclusion period for another study
* Subject under administrative or judicial control.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03844295
Study Brief:
Protocol Section:
NCT03844295