Obstructive Sleep ApneaBREATHENCT07331285
Bi-lateral HGN Therapy in Real-World Patients -Post Approval Research Investigation
An observational study of Obstructive Sleep Apnea, run by Nyxoah Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- This is a single arm study, all consented and eligible subjects will be implanted with the Genio® System 2.1
- Type of treatment
- Medical device
- How many people
- 229 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2026to Oct 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects diagnosed with moderate to severe obstructive sleep apnea (OSA) who are intolerant to or failed/refused PAP treatments.
Who may be able to join
- 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 join
- Combined central and mixed apnea-hypopnea index (AHI) greater than or equal to 25% of the total AHI.
- Any functional or structural problem, medical illness or condition that would prevent or interfere with implantation, activation or continued use of the Genio® Therapy.
- 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.
- 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:
Show all 10Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Alicia Castonguay contact
United States2 sites, 2 recruiting
- Recruiting
PharmaDev Clinical Research Institute, LLC
Miami, Florida, 33176
Olivia Falcon Valdes, 305-420-5636, ofalcon@pharmadevresearch.com
- Not yet recruiting
Nyxoah, Inc
Summit, New Jersey, 07901
Lorin Petre, +1 (908) 263-0228, clinical.studies@nyxoah.com
Alicia Castonguay, clinical.studies@nyxoah.com
About this study
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.
Read the detailed description
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.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- This is a single arm study, all consented and eligible subjects will be implanted with the Genio® System 2.1
- Keywords
- OSA, Hypoglossal Nerve Stimulation, Genio, obstructive sleep apnea
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This is a single arm study, all consented and eligible subjects will be implanted with the Genio® System 2.1Device
Also called Genio Therapy
Genio® System 2.1
| Study group | Role | What they receive |
|---|---|---|
| Genio System 2.1 | This is a single-arm study. All consented and eligible subjects will be implanted with the Genio 2.1 System. Receives: Device: This is a single arm study, all consented and eligible subjects will be implanted with the Genio® System 2.1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Apnea Hypopnea Index (AHI4%)
Percentage of responders at 12 months based on AHI4
Measured: 12 months
Change in Oxyhemoglobin Desaturation Index (ODI4%)
Percentage of responders at 12 months based on ODI4
Measured: 12 months
Device related SAEs
Incidence of device-related Serious Adverse Events at 12 months post-surgery
Measured: 12 months
Device-related and procedure-related SAEs
Incidence of device-related and procedure-related SAEs at 12 months post-surgery
Measured: 12 months
Secondary outcomes (9)
Mean change in AHI4
Mean change in AHI4 from screening to 12, 24, 36, 48, and 60 months post-surgery.
Measured: Baseline to 5 years
Mean change in ODI4
Mean change in ODI4 from screening to 12, 24, 36, 48, and 60 months post-surgery.
Measured: Baseline to 5 years
% responders AHI4
Percentage of responders at 24, 36, 48, and 60 months based on AHI4 according to "Sher criteria".
Measured: 2 years through 5 years
% responders ODI4
Percentage of responders at 24, 36, 48 and 60 months based on ODI4
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2 years through 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study startJun 2026 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionOct 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 229 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nyxoah Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07331285
- Sponsor's protocol ID
- CL-BREATHE-2026
- Acronym
- BREATHE
- Status last verified
- Jun 2026
- First submitted
- 29 Dec 2025
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Woodson BT, Kent DT, Huntley C, Hancock MK, Van Daele DJ, Boon MS, Huntley TC, Mickelson S, Gillespie MB, Suurna MV, Kacker A, Roy A, MacKay S, Withrow KP, Dedhia RC, Huyett P, Heiser C, Nicola SD, Makori F, Vanderveken OM, Padyha TA, Magalang UJ, Chio E, Kezirian EJ, Lewis R. Bilateral hypoglossal nerve stimulation for obstructive sleep apnea: a nonrandomized clinical trial. J Clin Sleep Med. 2025 Nov 1;21(11):1883-1891. doi: 10.5664/jcsm.11822.
PubMed 40702817
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bi-lateral HGN Therapy in Real-World Patients -Post Approval Research Investigation
- ClinicalTrials.gov ID
- NCT07331285
- Acronym / sponsor ID
- BREATHE / CL-BREATHE-2026
- Conditions
- Obstructive Sleep Apnea
- Keywords
- OSA, Hypoglossal Nerve Stimulation, Genio, obstructive sleep apnea
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 229 participants (estimated)
- Lead sponsor
- Nyxoah Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2026 (estimated)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2032 (estimated)
- First posted
- 9 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Genio System 2.1 | – | Device: This is a single arm study, all consented and eligible subjects will be implanted with the Genio® System 2.1This is a single-arm study. All consented and eligible subjects will be implanted with the Genio 2.1 System. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects diagnosed with moderate to severe obstructive sleep apnea (OSA) who are intolerant to or failed/refused PAP treatments.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- Combined central and mixed apnea-hypopnea index (AHI) greater than or equal to 25% of the total AHI.
- Any functional or structural problem, medical illness or condition that would prevent or interfere with implantation, activation or continued use of the Genio® Therapy.
- 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.
- Any condition or procedure that has compromised neurological control of the upper airway.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| This is a single arm study, all consented and eligible subjects will be implanted with the Genio® System 2.1Also: Genio TherapyGenio® System 2.1 | Device | Genio System 2.1 |
Primary outcome
Change in Apnea Hypopnea Index (AHI4%)
Time frame: 12 months
Percentage of responders at 12 months based on AHI4
Change in Oxyhemoglobin Desaturation Index (ODI4%)
Time frame: 12 months
Percentage of responders at 12 months based on ODI4
Device related SAEs
Time frame: 12 months
Incidence of device-related Serious Adverse Events at 12 months post-surgery
Device-related and procedure-related SAEs
Time frame: 12 months
Incidence of device-related and procedure-related SAEs at 12 months post-surgery
9 secondary outcomes
Mean change in AHI4
Time frame: Baseline to 5 years
Mean change in ODI4
Time frame: Baseline to 5 years
% responders AHI4
Time frame: 2 years through 5 years
% responders ODI4
Time frame: 2 years through 5 years
Subject Satisfaction
Time frame: 1 year through 5 years
Improvement in ESS
Time frame: 1 year through 5 years
Change in health status
Time frame: 1 year through 5 years
Clinician impression of change in Subject's health status
Time frame: 1 year through 5 years
Device-related Serious Adverse Events
Time frame: 2 years through 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Background: PubMed 40702817Woodson BT, Kent DT, Huntley C, Hancock MK, Van Daele DJ, Boon MS, Huntley TC, Mickelson S, Gillespie MB, Suurna MV, Kacker A, Roy A, MacKay S, Withrow KP, Dedhia RC, Huyett P, Heiser C, Nicola SD, Makori F, Vanderveken OM, Padyha TA, Magalang UJ, Chio E, Kezirian EJ, Lewis R. Bilateral hypoglossal nerve stimulation for obstructive sleep apnea: a nonrandomized clinical trial. J Clin Sleep Med. 2025 Nov 1;21(11):1883-1891. doi: 10.5664/jcsm.11822.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alicia Castonguay contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea, run by Nyxoah Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lorin Pétré (+1 (908) 263-0228, clinical.studies@nyxoah.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Apnea Hypopnea Index (AHI4%) (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07331285, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.