Early access
Sign in
Taking people in United StatesNo phase

Genio implant for obstructive sleep apnea in everyday care

Follows the Genio implant in people with obstructive sleep apnea who cannot use PAP.

Key facts

Who runs it
Nyxoah Inc.
Where
Miami and Summit, United StatesSee the 2 sites
Trial code
Registry title
Bi-lateral HGN Therapy in Real-World Patients -Post Approval Research Investigation
Status
Recruiting
People taking part
229 people, planned
Started
Jun 2026
Expected to end
Oct 2032
Type of study
Observational
Treatments tested
  • This is a single arm study, all consented and eligible subjects will be implanted with the Genio® System 2.1
Record updated
22 June 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with moderate to severe obstructive sleep apnea (breathing stops during sleep) who could not use, did not tolerate or refused PAP (air pressure mask) treatment. Everyone gets the Genio® System 2.1 implant.

Age
22 years and older; people above 75 years cannot join.
Sex
All sexes
Disease stage
Moderate to severe obstructive sleep apnea, with an apnea-hypopnea index (AHI, breathing pauses per hour) from 15 to 65. It must be measured on a full-night sleep study (PSG) done no earlier than 2 years before enrollment.
Earlier treatment
Standard treatments for moderate to severe OSA must have failed or not been tolerated, or the person cannot have them.
Biomarker or test result
A Drug-Induced Sleep Endoscopy (DISE, a camera check of the airway during medicine-induced sleep) result from no earlier than 2 years before enrollment.

Main reasons for not taking part

  • Central and mixed apneas make up 25% or more of the total AHI.
  • Body Mass Index (BMI) above 32 kg/m2, or Complete Concentric Collapse (CCC, the airway closing all around) at the soft palate.
  • An implanted device that may interact with the Genio® System 2.1.
  • Pregnant, planning pregnancy or breastfeeding.
  • A condition or procedure that has harmed nerve control of the upper airway.

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • 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)
  • Be adults 22 years of age and older
  • 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
  • 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
  • Agree to participate in the study and voluntarily sign and date an informed consent form
  • 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
  • Have a result of a Drug- Induced Sleep Endoscopy (DISE), no earlier than 2 years prior to enrollment

Who cannot take part

  • Any functional or structural problem, medical illness or condition that would prevent or interfere with implantation, activation or continued use of the Genio® Therapy
  • Any condition or procedure that has compromised neurological control of the upper airway
  • Be part of the populations for which the safety and effectiveness of the Genio® System 2.1 has not been fully assessed:; Patients below 22 or above 75 years of age; Patients with a Body Mass Index (BMI) above 32 kg/m2; Patients with an Apnea Hypopnea Index (AHI) below 15 or over 65 events/hr; Patients with Complete Concentric Collapse (CCC) at the soft palate level
  • Combined central and mixed apnea-hypopnea index (AHI) greater than or equal to 25% of the total AHI
  • Have an implantable device which may be susceptible to unintended interaction with the Genio® System 2.1
  • Women who are pregnant, planning to become pregnant or breastfeeding

Where in United States

  • PharmaDev Clinical Research Institute, LLCMiami, United StatesContact: Olivia Falcon ValdesTaking people
  • Nyxoah, IncSummit, United StatesContact: Lorin PetreNot yet recruiting

About the trial

What the trial wants to find out

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.

The group in the trial

  • Genio System 2.1

    This is a single-arm study. All consented and eligible subjects will be implanted with the Genio 2.1 System.

    Treatment: This is a single arm study, all consented and eligible subjects will be implanted with the Genio® System 2.1

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Bi-lateral HGN Therapy in Real-World Patients -Post Approval Research Investigation
Plain-language title
Genio implant for obstructive sleep apnea in everyday careGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
22 June 2026