Sleep Disorders Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have a sleep apnea severity score (called an AHI) between 15 and 65, confirmed by an overnight sleep study done within the last 2 years, with specific measurements recorded (AHI4 and ODI4).
• Adults aged 22 years or older.
• People whose moderate to severe sleep apnea has not responded to, has not been tolerated by, or is not suitable for standard sleep apnea treatments.
• People who have applied for insurance pre-approval for the Genio® Therapy device, or who are willing to cover any out-of-pocket costs themselves (the trial sponsor will not cover treatment costs).
• People who agree to take part voluntarily and sign and date a consent form.
• People who are willing and able to follow all study requirements, including lifestyle considerations, attending all follow-up visits, and completing all assessments and questionnaires for the full duration of the trial.
• People who have had a specific sleep procedure called a Drug-Induced Sleep Endoscopy (DISE) — a test done while lightly sedated to observe the airway — within the last 2 years (confirm with trial site).

Who may not be able to join:

• People whose sleep apnea events are made up of 25% or more of a type called central or mixed apneas, rather than the obstructive type.
• People with a physical or medical condition that could prevent or interfere with the implantation, activation, or ongoing use of the Genio® device.
• People who already have an implanted medical device that could interact in an unintended way with the Genio® System 2.1 (confirm with trial site).
• People who are pregnant, planning to become pregnant, or currently breastfeeding.
• People with any condition or procedure that has affected nerve control of the upper airway.
• People outside the age range of 22 to 75 years.
• People with a Body Mass Index (BMI) — a measure of body weight relative to height — above 32 kg/m².
• People with an AHI sleep apnea score below 15 or above 65 events per hour.
• People whose sleep study showed a specific pattern of airway collapse called Complete Concentric Collapse at the soft palate level (confirm with trial site).

Important: Always verify eligibility with the trial site directly before applying.