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:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2025-12-26 @ 11:07 AM
NCT ID:
NCT05881512
Eligibility Criteria:
Inclusion Criteria:
* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Male or female, aged 18 years or older
* In good general health, as evidenced by medical history and diagnosed with moderate or severe OSA
* In-lab PSG, within the last 6 months, with an AHI of 15-50/hour. In addition, \<25% of the respiratory events on the diagnostic PSG can be attributed to central apneas
* BMI less than or equal to 32
Exclusion Criteria:
* No or mild OSA (AHI \<15/h) or very severe OSA (AHI \>50/hour), exclusively postural sleep apnea, or isolated Rapid-Eye-Movement (REM) sleep associated OSA.
* Patients who are cachectic (BMI \<18.5 kg/m2) or obese (BMI \>32 kg/m2).
* Patients should not have enlarged tonsils (size 3-4) and/or adenoids, nasal polyps, neuromuscular disease, hypoglossal nerve palsy, abnormal pulmonary function tests, severe pulmonary hypertension, valvular heart disease, heart failure (New York Heart Association, NYHA III-IV), recent myocardial infarction, significant cardiac arrhythmias, atrial fibrillation, stroke, opioid usage, uncontrolled hypertension, known allergic reaction to adhesives or latex, active psychiatric disease, co-existing non-respiratory sleep disorder, pregnancy or significant metal implants or cardiac/other pacemakers.
* Patients with facial hair that affects the correct placement of the electrodes, if they are unwilling to shave.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05881512
Study Brief:
Protocol Section:
NCT05881512