This is a single arm study, all consented and eligible subjects will be implanted with the Genio® System 2.1
This is a single arm study, all consented and eligible subjects will be implanted with the Genio® System 2.1: Genio® System 2.1
Study summary
The objective of the BREATHE study is to demonstrate the continued safety and effectiveness of the Genio® System in treating subjects diagnosed with moderate to severe obstructive sleep apnea (OSA) who are intolerant to or failed/refused PAP treatments.
Eligibility
Sex
ALL
Min age
22 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Have an apnea-hypopnea index (AHI) greater than or equal to 15 and less than or equal to 65, measured on a full-night PSG performed no earlier than 2 years prior to enrollment (AHI4 and ODI4 available).
2. Be adults 22 years of age and older.
3. Have been confirmed to have failed, not tolerated, or be ineligible to be treated with current standard of care treatments for moderate to severe OSA.
4. Have pursued insurance pre-authorization for Genio® Therapy, recognizing that pre-authorization does not ensure payment, or demonstrate willingness to assume any out-of-pocket costs. The sponsor will not be responsible for treatment-related charges.
5. Agree to participate in the study and voluntarily sign and date an informed consent form.
6. Be willing and capable of complying with all study requirements, including specific lifestyle considerations, performing all follow-up visits, evaluation procedures and questionnaires for the whole duration of the trial.
7. Have a result of a Drug- Induced Sleep Endoscopy (DISE), no earlier than 2 years prior to enrollment.
Exclusion Criteria:
1. Combined central and mixed apnea-hypopnea index (AHI) greater than or equal to 25% of the total AHI.
2. Any functional or structural problem, medical illness or condition that would prevent or interfere with implantation, activation or continued use of the Genio® Therapy.
3. Have an implantable device which may be susceptible to unintended interaction with the Genio® System 2.1.
4. Women who are pregnant, planning to become pregnant or breastfeeding.
5. Any condition or procedure that has compromised neurological control of the upper airway.
6. Be part of the populations for which the safety and effectiveness of the Genio® System 2.1 has not been fully assessed:
1. Patients below 22 or above 75 years of age.
2. Patients with a Body Mass Index (BMI) above 32 kg/m2.
3. Patients with an Apnea Hypopnea Index (AHI) below 15 or over 65 events/hr.
4. Patients with Complete Concentric Collapse (CCC) at the soft palate level.
Primary outcome measure(s)
Change in Apnea Hypopnea Index (AHI4%) — 12 months Percentage of responders at 12 months based on AHI4
Change in Oxyhemoglobin Desaturation Index (ODI4%) — 12 months Percentage of responders at 12 months based on ODI4
Device related SAEs — 12 months Incidence of device-related Serious Adverse Events at 12 months post-surgery
Device-related and procedure-related SAEs — 12 months Incidence of device-related and procedure-related SAEs at 12 months post-surgery
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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