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Sleep Apnea, ObstructiveACCCESSNCT05592002

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

A study testing Genio System in people with Sleep Apnea, Obstructive, run by Nyxoah S.A. at 16 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 22 to 75 years
Conditions the study is for
Sleep Apnea, Obstructive
What is being tested?
Genio System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
124 participants
Where
16 sitesUnited States
Study dates
28 Dec 2022to Sep 2028
Phase
Interventional
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Age from 22 to 75 years (inclusive). Participant cannot be under guardianship, under curatorship or under judicial protection.
  • 2. 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.
  • 4. Has either not tolerated, has failed or refused positive airway pressure (PAP) treatments.
  • 5. 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.
  • 6. Complete concentric collapse at the level of the soft palate based on screening DISE.
  • 7. 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.

Who cannot join

  • 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,
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  • 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,
  • Persistent uncontrolled diagnosed hypertension despite medications,
  • Coagulopathy or required anticoagulant or antiplatelet medications (such as warfarin, clopidogrel (Plavix) or similar; prophylactic aspirin not exclusionary) that cannot be safely stopped in the perioperative period, Subjects meeting any of the following criteria will be excluded from participation in this study:
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  • 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,
  • Persistent uncontrolled diagnosed hypertension despite medications,
  • Coagulopathy or required anticoagulant medications (such as warfarin, clopidogrel (Plavix) or similar; prophylactic aspirin not exclusionary) that cannot be safely stopped in the perioperative period,
  • Degenerative neurological disorder (i.e., Parkinson's disease, Alzheimer's disease),
  • Acute illness or infection,
  • Any other chronic medical illness or condition that contraindicates a surgical procedure or general anesthesia in the judgment of the investigator.
  • Diagnosed psychiatric disease (e.g., psychotic illness, uncontrolled major depression or acute anxiety attacks) that prevents participant compliance with the requirements of the investigational study testing,
  • Substance or alcohol abuse history within the previous 3 years. Alcohol and substance abuse are defined as follows:
  • Alcohol: no days with less than 3 or 4 standard drinks for women and men respectively ii. Substance: the use of any substance in an amount unapproved by the investigator or considered illegal. The drugs most commonly abused include cocaine, marijuana, heroin (or substitution treatment), prescription drugs (especially painkillers), methamphetamines, and various other illegal substances.
  • Life expectancy of less than 12 months.
  • Prior surgery or treatments that could compromise the effectiveness of the Genio® System:
  • Airway cancer surgery or radiation,
  • Mandible or maxilla surgery in the previous 5 years (not counting dental treatments),
  • Other upper airway surgery to remove obstructions related to OSA in the previous 3 months (e.g., uvulopalatopharyngoplasty (UPPP), tonsillectomy, nasal airway surgery),
  • Prior hypoglossal nerve stimulation device implantation.
  • Has an Active Implantable Medical Device (AIMD) even if the device can be temporarily turned off.
  • Participation in another clinical study with an active treatment arm.
  • Plan to become pregnant, currently pregnant, or breastfeeding during the study period.

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

United States16 sites

  • ENT and Allergy Associates of Florida, LLC

    Boca Raton, Florida, 33487

  • Massachusetts Eye & Ear

    Boston, Massachusetts, 02114

  • Center for ENT and Allergy, PC Ascension Medical Group

    Carmel, Indiana, 46032

  • Colorado ENT & Allergy

    Colorado Springs, Colorado, 80923

  • Bogan Sleep Consultants, LLC

    Columbia, South Carolina, 29201

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • University of Iowa Institute for Clinical & Translational Science

    Iowa City, Iowa, 52242

  • University of Kansas

    Kansas City, Kansas, 66160

  • University of Miami

    Miami, Florida, 33136

  • PharmaDev Clinical Research Institute,

    Miami, Florida, 33176

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Eastern Virginia Medical School

    Norfolk, Virginia, 23507

  • Hospital of the University Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Thomas Jefferson University Department of Otolaryngology

    Philadelphia, Pennsylvania, 19107

  • University of Rochester

    Rochester, New York, 14627

  • University of South Florida

    Tampa, Florida, 33620

Other trials in United States

About this study

Official title: A Multicenter Study to Assess the Safety and Effectiveness of the Genio® Dual-sided Hypoglossal Nerve Stimulation System for the Treatment of Obstructive Sleep Apnea in Subjects With Complete Concentric Collapse of the Soft Palate.

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.

Read the detailed description

Nyxoah has developed the Genio® 2.1 System with the intention of treating patients with moderate to severe obstructive sleep apnea.

In overview, the System includes an Implantable Stimulator (IS) designed to stimulate the hypoglossal nerve branches (i.e., both the left and the right). The IS does not include a battery but receives energy pulses transmitted by an Activation Chip (AC) which is attached to an adhesive Disposable Patch (DP) and placed on the patient's skin under the chin. Stimulation of the hypoglossal nerve causes the tongue muscles to contract with the intention to maintain an open airway.

Being tested
Genio System
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.

  • Genio SystemDevice

    Also called Genio System 2.0

    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.

Study groups in NCT05592002
Study groupRoleWhat they receive
Genio® 2.1 SystemExperimentalSystem 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
Receives: Device: Genio System

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2022
  2. Study start28 Dec 2022
  3. Primary completionSep 2026 (estimated)
  4. Study completionSep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
124 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05592002
Sponsor's protocol ID
CL-CCC2022
Acronym
ACCCESS
Status last verified
Aug 2025
First submitted
13 Oct 2022
Last updated
5 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Genio System in people with Sleep Apnea, Obstructive, run by Nyxoah S.A. at 16 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 6 inclusion and 56 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: under way, not looking for participants, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Effectiveness Endpoint (time frame: The duration of the study is expected to be approximately 4.5 years.). 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 NCT05592002.

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 5 Sep 2025.

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