Safety and Effectiveness of the Genio® bilAteral Stimulation for Treatment of Complete Concentric CollapsE and OSA.

NCT05592002 | Active Not Recruiting DMC FDA Device

• 1 other identifier: CL-CCC2022
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 16

Brief Summary

The solution offered by the Genio System to treat OSA patients with CCC using bilateral HGNS has a favorable risk-benefit ratio, as demonstrated by evidence from 2 studies.

Conditions

Sleep Apnea, Obstructive

Outcome Measures

Primary Outcomes (1)

• Primary Effectiveness Endpoint

  The effectiveness endpoint of the study is assessed through the reduction in the severity of OSA over a period of 12 months post-implant. Primary effectiveness endpoint: percentage of responders based on a change in apnea-hypopnea index (AHI4) and oxygen desaturation index (ODI4) at 12 months post-activation. A responder is defined as any subject with a reduction of 50% in AHI4 from Baseline and a remaining AHI4 \< 20 events/hour (aka "Sher Criteria"), AND 25% in ODI4 from Baseline.

  The duration of the study is expected to be approximately 4.5 years.

Study Arms (1)

Genio® 2.1 System

EXPERIMENTAL

System Component Genio® System 2.1 Implantable Stimulator (IS) Genio® Implantable Stimulator External Stimulator (ES) Genio® External Stimulator Disposable Patch (DP) Genio® Disposable Patch Activation Chip (AC) Genio® Activation Chip (AC) Model #2364 Charging Unit (CU) Genio® Charging Unit (CU) Model #2238 Sleep Lab Application Genio® Sleep Lab Application Smartphone Application (optional) Genio® Smartphone Application

Device: Genio System

Interventions

Genio System DEVICE

The Genio® IS electrode placement does not require an extensive surgical manipulation of the hypoglossal nerve, it requires only a single incision site and does not require battery replacements as those are external components. Whereas UPPP surgery and other similar upper airway enlargement surgeries are much more extensive, are irreversible and tend to have more complications and modest long-term results in reducing OSA severity and symptoms. In summary, the solution offered by the Genio System to treat OSA patients with CCC using bilateral HGNS has a favorable risk-benefit ratio, as demonstrated by evidence from 2 studies.

Also known as: Genio System 2.0

Genio® 2.1 System

Eligibility Criteria

• Age: 22 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age from 22 to 75 years (inclusive). Participant cannot be under guardianship, under curatorship or under judicial protection.
• \. Body mass index (BMI) ≤ 32 kg/m2. 3. Positive cricomental space (≥ 0 cm). The cricomental space is the distance between the neck and the bisection of a line from the chin to the cricoid membrane when the head is in a neutral position.
• \. Has either not tolerated, has failed or refused positive airway pressure (PAP) treatments.
• \. Moderate to severe OSA (15≤AHI4≤65 where combined central and mixed AHI\<25% of the total AHI) based on a screening HST and confirmed in Baseline PSG.
• \. Complete concentric collapse at the level of the soft palate based on screening DISE.
• \. Willing and capable of complying with all study requirements, including specific lifestyle considerations, performing all follow-up visits and sleep studies, evaluation procedures and questionnaires for the whole duration of the trial.

You may not qualify if:

• Inadequately treated sleep disorders other than OSA that would confound functional sleep assessment:
• Severe chronic insomnia,
• Insufficient sleep syndrome (\<6 hours sleep per night),
• Narcolepsy,
• Restless legs syndrome,
• REM behavior disorder,
• Others deemed sufficient disorders that would confound functional sleep assessment in the judgment of the investigator.
• Taking medications that may alter consciousness, the pattern of respiration, or sleep architecture as determined by the investigator.
• Major anatomical or functional abnormalities that would impair the ability of the Genio® System to treat OSA:
• Craniofacial abnormalities narrowing the airway or the implantation site,
• Palatine tonsil size 3+ or 4+ by the Brodsky Classification,
• Fixed upper airway obstructions (tumor, polyps, nasal obstruction),
• Congenital malformations in the airway,
• Hypoglossal nerve palsy (bilateral limited tongue movement, or unilateral unintended tongue deviation during protrusion),
• Existing swallowing difficulty as measured by a score of ≥3 on the EAT-10 questionnaire

Sponsors & Collaborators

• Nyxoah S.A.: lead
• Nyxoah Inc.: collaborator

Study Sites (16)

Colorado ENT & Allergy

Colorado Springs, Colorado, 80923, United States

Location

ENT and Allergy Associates of Florida, LLC

Boca Raton, Florida, 33487, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

PharmaDev Clinical Research Institute,

Miami, Florida, 33176, United States

Location

University of South Florida

Tampa, Florida, 33620, United States

Location

Center for ENT and Allergy, PC Ascension Medical Group

Carmel, Indiana, 46032, United States

Location

University of Iowa Institute for Clinical & Translational Science

Iowa City, Iowa, 52242, United States

Location

University of Kansas

Kansas City, Kansas, 66160, United States

Location

Massachusetts Eye & Ear

Boston, Massachusetts, 02114, United States

Location

University of Rochester

Rochester, New York, 14627, United States

Location

Hospital of the University Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Thomas Jefferson University Department of Otolaryngology

Philadelphia, Pennsylvania, 19107, United States

Location

Bogan Sleep Consultants, LLC

Columbia, South Carolina, 29201, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Eastern Virginia Medical School

Norfolk, Virginia, 23507, United States

Location

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

Study Officials

• Jey Subarroyan, PhD

  Nyxoah S.A.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2022
• First Posted: October 24, 2022
• Study Start: December 28, 2022
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2028
• Last Updated: September 5, 2025

Record last verified: 2025-08

Locations

US (16)