ACTIVE_NOT_RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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.

Quick Facts

Study Start:2022-12-28

Study Completion:2028-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05592002

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 1\. Age from 22 to 75 years (inclusive). Participant cannot be under guardianship, under curatorship or under judicial protection. *	1. Inadequately treated sleep disorders other than OSA that would confound functional sleep assessment: 1. Severe chronic insomnia, 2. Insufficient sleep syndrome (\<6 hours sleep per night), 3. Narcolepsy, 4. Restless legs syndrome, 5. REM behavior disorder, 6. Others deemed sufficient disorders that would confound functional sleep assessment in the judgment of the investigator. 2. Taking medications that may alter consciousness, the pattern of respiration, or sleep architecture as determined by the investigator. 3. Major anatomical or functional abnormalities that would impair the ability of the Genio® System to treat OSA: 1. Craniofacial abnormalities narrowing the airway or the implantation site, 2. Palatine tonsil size 3+ or 4+ by the Brodsky Classification, 3. Fixed upper airway obstructions (tumor, polyps, nasal obstruction), 4. Congenital malformations in the airway, 5. Hypoglossal nerve palsy (bilateral limited tongue movement, or unilateral unintended tongue deviation during protrusion), 6. Existing swallowing difficulty as measured by a score of ≥3 on the EAT-10 questionnaire 7. Others deemed sufficient to impair the ability of the Genio® System to treat OSA in the judgment of the investigator. 4. Significant comorbidities that contraindicate surgery or general anesthesia: 1. Revised Cardiac Risk Index Class III or IV, 2. Persistent uncontrolled diagnosed hypertension despite medications, 3. 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: 1. Inadequately treated sleep disorders other than OSA that would confound functional sleep assessment: 1. Severe chronic insomnia, 2. Insufficient sleep syndrome (\<6 hours sleep per night), 3. Narcolepsy, 4. Restless legs syndrome, 5. REM behavior disorder, 6. Others deemed sufficient disorders that would confound functional sleep assessment in the judgment of the investigator. 2. Taking medications that may alter consciousness, the pattern of respiration, or sleep architecture as determined by the investigator. 3. Major anatomical or functional abnormalities that would impair the ability of the Genio® System to treat OSA: 1. Craniofacial abnormalities narrowing the airway or the implantation site, 2. Palatine tonsil size 3+ or 4+ by the Brodsky Classification, 3. Fixed upper airway obstructions (tumor, polyps, nasal obstruction), 4. Congenital malformations in the airway, 5. Hypoglossal nerve palsy (bilateral limited tongue movement, or unilateral unintended tongue deviation during protrusion), 6. Existing swallowing difficulty as measured by a score of ≥3 on the EAT-10 questionnaire 7. Others deemed sufficient to impair the ability of the Genio® System to treat OSA in the judgment of the investigator. 4. Significant comorbidities that contraindicate surgery or general anesthesia: 1. Revised Cardiac Risk Index Class III or IV, 2. Persistent uncontrolled diagnosed hypertension despite medications, 3. 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, 4. Degenerative neurological disorder (i.e., Parkinson's disease, Alzheimer's disease), 5. Acute illness or infection, 6. Any other chronic medical illness or condition that contraindicates a surgical procedure or general anesthesia in the judgment of the investigator. 5. 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, 6. Substance or alcohol abuse history within the previous 3 years. Alcohol and substance abuse are defined as follows: 7. Life expectancy of less than 12 months. 8. Prior surgery or treatments that could compromise the effectiveness of the Genio® System: 1. Airway cancer surgery or radiation, 2. Mandible or maxilla surgery in the previous 5 years (not counting dental treatments), 3. Other upper airway surgery to remove obstructions related to OSA in the previous 3 months (e.g., uvulopalatopharyngoplasty (UPPP), tonsillectomy, nasal airway surgery), 4. Prior hypoglossal nerve stimulation device implantation. 9. Has an Active Implantable Medical Device (AIMD) even if the device can be temporarily turned off. 10. Participation in another clinical study with an active treatment arm. 11. Plan to become pregnant, currently pregnant, or breastfeeding during the study period.

Inclusion Criteria

Exclusion Criteria

* 1\. Age from 22 to 75 years (inclusive). Participant cannot be under guardianship, under curatorship or under judicial protection.
*

1. Inadequately treated sleep disorders other than OSA that would confound functional sleep assessment:
1. Severe chronic insomnia,
2. Insufficient sleep syndrome (\<6 hours sleep per night),
3. Narcolepsy,
4. Restless legs syndrome,
5. REM behavior disorder,
6. Others deemed sufficient disorders that would confound functional sleep assessment in the judgment of the investigator.
2. Taking medications that may alter consciousness, the pattern of respiration, or sleep architecture as determined by the investigator.
3. Major anatomical or functional abnormalities that would impair the ability of the Genio® System to treat OSA:
1. Craniofacial abnormalities narrowing the airway or the implantation site,
2. Palatine tonsil size 3+ or 4+ by the Brodsky Classification,
3. Fixed upper airway obstructions (tumor, polyps, nasal obstruction),
4. Congenital malformations in the airway,
5. Hypoglossal nerve palsy (bilateral limited tongue movement, or unilateral unintended tongue deviation during protrusion),
6. Existing swallowing difficulty as measured by a score of ≥3 on the EAT-10 questionnaire
7. Others deemed sufficient to impair the ability of the Genio® System to treat OSA in the judgment of the investigator.
4. Significant comorbidities that contraindicate surgery or general anesthesia:
1. Revised Cardiac Risk Index Class III or IV,
2. Persistent uncontrolled diagnosed hypertension despite medications,
3. 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:
1. Inadequately treated sleep disorders other than OSA that would confound functional sleep assessment:
1. Severe chronic insomnia,
2. Insufficient sleep syndrome (\<6 hours sleep per night),
3. Narcolepsy,
4. Restless legs syndrome,
5. REM behavior disorder,
6. Others deemed sufficient disorders that would confound functional sleep assessment in the judgment of the investigator.
2. Taking medications that may alter consciousness, the pattern of respiration, or sleep architecture as determined by the investigator.
3. Major anatomical or functional abnormalities that would impair the ability of the Genio® System to treat OSA:
1. Craniofacial abnormalities narrowing the airway or the implantation site,
2. Palatine tonsil size 3+ or 4+ by the Brodsky Classification,
3. Fixed upper airway obstructions (tumor, polyps, nasal obstruction),
4. Congenital malformations in the airway,
5. Hypoglossal nerve palsy (bilateral limited tongue movement, or unilateral unintended tongue deviation during protrusion),
6. Existing swallowing difficulty as measured by a score of ≥3 on the EAT-10 questionnaire
7. Others deemed sufficient to impair the ability of the Genio® System to treat OSA in the judgment of the investigator.
4. Significant comorbidities that contraindicate surgery or general anesthesia:
1. Revised Cardiac Risk Index Class III or IV,
2. Persistent uncontrolled diagnosed hypertension despite medications,
3. 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,
4. Degenerative neurological disorder (i.e., Parkinson's disease, Alzheimer's disease),
5. Acute illness or infection,
6. Any other chronic medical illness or condition that contraindicates a surgical procedure or general anesthesia in the judgment of the investigator.
5. 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,
6. Substance or alcohol abuse history within the previous 3 years. Alcohol and substance abuse are defined as follows:
7. Life expectancy of less than 12 months.
8. Prior surgery or treatments that could compromise the effectiveness of the Genio® System:
1. Airway cancer surgery or radiation,
2. Mandible or maxilla surgery in the previous 5 years (not counting dental treatments),
3. Other upper airway surgery to remove obstructions related to OSA in the previous 3 months (e.g., uvulopalatopharyngoplasty (UPPP), tonsillectomy, nasal airway surgery),
4. Prior hypoglossal nerve stimulation device implantation.
9. Has an Active Implantable Medical Device (AIMD) even if the device can be temporarily turned off.
10. Participation in another clinical study with an active treatment arm.
11. Plan to become pregnant, currently pregnant, or breastfeeding during the study period.

Contacts and Locations

Principal Investigator

Jey Subarroyan, PhD

STUDY_DIRECTOR

Nyxoah S.A.

Study Locations (Sites)

Colorado ENT & Allergy

Colorado Springs, Colorado, 80923

United States

ENT and Allergy Associates of Florida, LLC

Boca Raton, Florida, 33487

United States

University of Miami

Miami, Florida, 33136

United States

PharmaDev Clinical Research Institute,

Miami, Florida, 33176

United States

University of South Florida

Tampa, Florida, 33620

United States

Center for ENT and Allergy, PC Ascension Medical Group

Carmel, Indiana, 46032

United States

University of Iowa Institute for Clinical & Translational Science

Iowa City, Iowa, 52242

United States

University of Kansas

Kansas City, Kansas, 66160

United States

Massachusetts Eye & Ear

Boston, Massachusetts, 02114

United States

University of Rochester

Rochester, New York, 14627

United States

Hospital of the University Pennsylvania

Philadelphia, Pennsylvania, 19104

United States

Thomas Jefferson University Department of Otolaryngology

Philadelphia, Pennsylvania, 19107

United States

Bogan Sleep Consultants, LLC

Columbia, South Carolina, 29201

United States

Vanderbilt University Medical Center

Nashville, Tennessee, 37232

United States

University of Texas Southwestern Medical Center

Dallas, Texas, 75390

United States

Eastern Virginia Medical School

Norfolk, Virginia, 23507

United States

Collaborators and Investigators

Sponsor: Nyxoah S.A.

Jey Subarroyan, PhD, STUDY_DIRECTOR, Nyxoah S.A.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-28

Study Completion Date2028-09

Study Record Updates

Study Start Date2022-12-28

Study Completion Date2028-09

Terms related to this study

Additional Relevant MeSH Terms

Sleep Apnea, Obstructive