This study, called BREATHE, is looking at the continued safety and effectiveness of the Genio® System 2.1. This device is used to treat moderate to severe obstructive sleep apnea (OSA), a condition where breathing repeatedly stops and starts during sleep. You might be able to join if you are 22 years or older, have an Apnea-Hypopnea Index (AHI) between 15 and 65, and have not been able to use or tolerate other standard treatments like CPAP. The study will measure how much your AHI (a measure of sleep apnea severity) and Oxyhemoglobin Desaturation Index (ODI, a measure of oxygen drops during sleep) change after 12 months, and will also track any device-related serious side effects. The current recruitment status is unclear.

Study design

This is an observational study with a single group of participants, meaning everyone receives the Genio® System 2.1. The study plans to enroll 229 people.

What's involved

After receiving the Genio® System 2.1 implant, you would have an activation visit around 8 weeks later. You would then have follow-up visits at 6, 9, and 12 months, and every 6 months for up to 5 years.

Compensation

Not stated in the trial record.

Follow-up

Participants will be followed for up to 5 years after the implant surgery, with endpoints assessed at 12, 24, 36, 48, and 60 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.