An observational study in Obstructive Sleep Apnea, sponsored by Nyxoah Inc.. Recruiting at 2 sites in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-06-22.
Sponsored by Nyxoah Inc. · Observational
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.
BREATHE is a multicenter, prospective, single-arm, post-approval study. Following a baseline visit and implantation of the Genio® System 2.1, subjects will be asked to return for a therapy activation visit at approximately 8 weeks post-implant surgery.
The subject will have follow-up visits at 6 months, 9 months, 12 months and every 6-months thereafter up to 5 years post-implant surgery. Additional visits (for device titration or other reasons) are per standard of care and at the Investigator's discretion. Endpoints will be assessed at 12, 24, 36, 48 and 60 months.
2,198 studies on the registry are indexed under Sleep Apnea, Obstructive; 469 are open to participants now.
This study's planned enrollment of 229 is above the median of 104 across 648 observational studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →This is the only study on the registry with Nyxoah Inc. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Subjects diagnosed with moderate to severe obstructive sleep apnea (OSA) who are intolerant to or failed/refused PAP treatments.
Exclusion Criteria:
Be part of the populations for which the safety and effectiveness of the Genio® System 2.1 has not been fully assessed:
This is a single-arm study. All consented and eligible subjects will be implanted with the Genio 2.1 System.
Device: This is a single arm study, all consented and eligible subjects will be implanted with the Genio® System 2.1
Genio® System 2.1
Also known as: Genio Therapy
Change in Apnea Hypopnea Index (AHI4%)
Percentage of responders at 12 months based on AHI4
Time frame: 12 months
Change in Oxyhemoglobin Desaturation Index (ODI4%)
Percentage of responders at 12 months based on ODI4
Time frame: 12 months
Device related SAEs
Incidence of device-related Serious Adverse Events at 12 months post-surgery
Time frame: 12 months
Device-related and procedure-related SAEs
Incidence of device-related and procedure-related SAEs at 12 months post-surgery
Time frame: 12 months
Mean change in AHI4
Mean change in AHI4 from screening to 12, 24, 36, 48, and 60 months post-surgery.
Time frame: Baseline to 5 years
Mean change in ODI4
Mean change in ODI4 from screening to 12, 24, 36, 48, and 60 months post-surgery.
Time frame: Baseline to 5 years
% responders AHI4
Percentage of responders at 24, 36, 48, and 60 months based on AHI4 according to "Sher criteria".
Time frame: 2 years through 5 years
% responders ODI4
Percentage of responders at 24, 36, 48 and 60 months based on ODI4
Time frame: 2 years through 5 years
Subject Satisfaction
Subject reported satisfaction with therapy (measured via bespoke questionnaire) measured at 12, 24, 36, 48, and 60 months post-surgery
Time frame: 1 year through 5 years
Improvement in ESS
Improvement in OSA-related symptoms (measured via Epworth Sleepiness Scale (ESS) questionnaire) measured at 12, 24, 36, 48, and 60 months post-surgery
Time frame: 1 year through 5 years
Change in health status
Subject reported impression of change in health status (measured via Patient Global Impression of Change (PGIC) questionnaire) at 12, 24, 36, 48, and 60 months post-surgery.
Time frame: 1 year through 5 years
Clinician impression of change in Subject's health status
Clinician impression of change in Subject's health status (measured via Clinician Global Impression of Change (CGIC) questionnaire) at 12, 24, 36, 48, and 60 months post-surgery.
Time frame: 1 year through 5 years
Device-related Serious Adverse Events
Incidence of device-related Serious Adverse Events, as reported by Investigator and adjudicated by the CEC, at 24, 36, 48, and 60 months post-surgery.
Time frame: 2 years through 5 years
Plan to share: No
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