Bi-lateral HGN Therapy in Real-World Patients -Post Approval Research Investigation

NCT07331285 | Not Yet Recruiting FDA Device

• 1 other identifier: CL-BREATHE-2026
• Study Type: observational
• Target: 229
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obstructive Sleep Apnea

Keywords

OSA; Hypoglossal Nerve Stimulation; Genio; obstructive sleep apnea

Outcome Measures

Primary Outcomes (4)

• Change in Apnea Hypopnea Index (AHI4%)

  Percentage of responders at 12 months based on AHI4

  12 months

• Change in Oxyhemoglobin Desaturation Index (ODI4%)

  Percentage of responders at 12 months based on ODI4

  12 months

• Device related SAEs

  Incidence of device-related Serious Adverse Events at 12 months post-surgery

  12 months

• Device-related and procedure-related SAEs

  Incidence of device-related and procedure-related SAEs at 12 months post-surgery

  12 months

Secondary Outcomes (9)

• Mean change in AHI4

  Baseline to 5 years

• Mean change in ODI4

  Baseline to 5 years

• % responders AHI4

  2 years through 5 years

• % responders ODI4

  2 years through 5 years

• Subject Satisfaction

  1 year through 5 years

Study Arms (1)

Genio System 2.1

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

Interventions

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

Genio® System 2.1

Also known as: Genio Therapy

Genio System 2.1

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects diagnosed with moderate to severe obstructive sleep apnea (OSA) who are intolerant to or failed/refused PAP treatments.

You may qualify if:

• 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.

You may not qualify if:

• 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:
• 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.

Sponsors & Collaborators

• Nyxoah Inc.: lead

Study Sites (1)

Nyxoah, Inc

Summit, New Jersey, 07901, United States

Location

Related Publications (1)

• 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.

  PMID: 40702817 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Central Study Contacts

Lorin Pétré

CONTACT

+1 (908) 263-0228; clinical.studies@nyxoah.com

Alicia Castonguay

CONTACT

clinical.studies@nyxoah.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2025
• First Posted: January 9, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2032
• Last Updated: March 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)