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

Running, not enrolling · Not applicable

Conditions studied: Sleep Apnea, Obstructive

In brief

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.

Key facts

Study ID

NCT05592002

Run by

Nyxoah S.A.

People needed

124

Starts

2022-12-28

Expected to finish

2028-09-01

Last updated by the study team

2025-09-05

Who can join

Age: 22 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 1. 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.
• Exclusion Criteria:
• 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
• Others deemed sufficient to impair the ability of the Genio® System to treat OSA in the judgment of the investigator.
• Significant comorbidities that contraindicate surgery or general anesthesia:
• Revised Cardiac Risk Index Class III or IV,

Where it is running

• Colorado ENT & Allergy — Colorado Springs, Colorado, United States
• ENT and Allergy Associates of Florida, LLC — Boca Raton, Florida, United States
• University of Miami — Miami, Florida, United States
• PharmaDev Clinical Research Institute, — Miami, Florida, United States
• University of South Florida — Tampa, Florida, United States
• Center for ENT and Allergy, PC Ascension Medical Group — Carmel, Indiana, United States
• University of Iowa Institute for Clinical & Translational Science — Iowa City, Iowa, United States
• University of Kansas — Kansas City, Kansas, United States
• Massachusetts Eye & Ear — Boston, Massachusetts, United States
• University of Rochester — Rochester, New York, United States
• Hospital of the University Pennsylvania — Philadelphia, Pennsylvania, United States
• Thomas Jefferson University Department of Otolaryngology — Philadelphia, Pennsylvania, United States
• Bogan Sleep Consultants, LLC — Columbia, South Carolina, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• Eastern Virginia Medical School — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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