Clinical trial NCT05592002: Safety and Effectiveness of the Genio® bilAteral Stimulation for Treatment of Complete Concentric CollapsE and OSA.
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sleep Apnea, Obstructive
Lead sponsor: Nyxoah S.A.
Sponsor class: INDUSTRY
Collaborators: name: Nyxoah Inc.
First posted: 2022-10-24
Enrollment: 124
Sex: ALL
Minimum age (years): 22
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.
* Exclusion Criteria:

  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:

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  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:

     i. 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.
  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.

Primary outcomes:
measure: Primary Effectiveness Endpoint
timeFrame: The duration of the study is expected to be approximately 4.5 years.
Secondary outcomes:
Other outcomes:
Locations:
city: Colorado Springs
country: United States
facility: Colorado ENT & Allergy
state: Colorado
city: Boca Raton
country: United States
facility: ENT and Allergy Associates of Florida, LLC
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Miami
country: United States
facility: PharmaDev Clinical Research Institute,
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Carmel
country: United States
facility: Center for ENT and Allergy, PC Ascension Medical Group
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Institute for Clinical & Translational Science
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas
state: Kansas
city: Boston
country: United States
facility: Massachusetts Eye & Ear
state: Massachusetts
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Philadelphia
country: United States
facility: Hospital of the University Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Department of Otolaryngology
state: Pennsylvania
city: Columbia
country: United States
facility: Bogan Sleep Consultants, LLC
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Norfolk
country: United States
facility: Eastern Virginia Medical School
state: Virginia
Study officials:
affiliation: Nyxoah S.A.
name: Jey Subarroyan, PhD
role: STUDY_DIRECTOR
References: