A post-market clinical follow up of the Genio® System for the treatment of Obstructive Sleep Apnea in adults

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 25

Inclusion Criteria

A patient must meet all of the following inclusion criteria to be eligible for
inclusion in this study:
1. Age above 18 years.
2. Body Mass Index (BMI) < 35 kg/m2.
3. Cricomental space positive (>= 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. AHI between 15 to 65 events/hour documented by the closest PSG performed at
the time of patient ICF signature and within maximum 12 months of screening (as
long as the patient stays within ±4kg of their initial weight and has no
additional significant comorbidities) and fulfilling the required technical
criteria or during the screening phase.
5. Non-Positional OSA as per investigator*s assessment or the patient has
either not tolerated, has failed or refused positional therapy.
6. Combined central and mixed AHI < 25% of the total AHI.
7. Has either not tolerated, has failed or refused Positive Airway Pressure
(PAP) or Mandibular Advancement Device (MAD) treatments.
8. Written informed consent obtained from the patient prior to performing any
study specific procedure.
9. Willing and capable to comply 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

Patients 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:
a. Severe chronic insomnia,
b. Insufficient sleep syndrome,
c. Narcolepsy,
d. Restless legs syndrome,
e. REM behavior disorder,
f. Others deemed sufficient disorders that would confound functional sleep
assessment in the judgment of the Investigator.
2. Taking medications that in the opinion of the Investigator may alter
consciousness, the pattern of respiration, or sleep architecture.
3. Major anatomical or functional abnormalities that would impair the ability
of the Genio® system to treat OSA:
a. Craniofacial abnormalities narrowing the airway or the implantation site,
b. Palatine tonsil size 3+ or 4+ by the Brodsky Classification,
c. Relevant fixed upper airway obstructions (tumor, polyps, nasal obstruction),
d. Complete concentric collapse of the soft palate observed during Drug-Induced
Sleep Endoscopy (DISE) performed within maximum 24 months of screening and
fulfilling the required technical criteria or during the screening phase.
e. Congenital malformations in the airway,
f. Hypoglossal nerve palsy (bilateral limited tongue movement, or unilateral
unintended tongue deviation during protrusion),
g. Others deemed sufficient to impair the ability of the Genio® system to treat
OSA in the judgment of the Investigator.
4. Inadequately treated psychiatric disease (e.g., psychotic illness,
uncontrolled major depression or acute anxiety attacks) that prevents patient
compliance with the requirements of the investigational study testing.
5. Severe history of drug or alcohol abuse within the previous 3 years.
6. Life expectancy < 12 months.
7. Any medical illness or condition that contraindicates a surgical procedure
under general anesthesia in the judgment of the investigator, or that would
prevent the implantation of the Implantable Stimulator or the placement of
Activation Chip/Disposable Patch.
8. Prior surgery or treatments that could compromise the effectiveness of the
Genio® system:
a. Airway cancer surgery or radiation,
b. Mandible or maxilla surgery in the previous 3 years (not counting dental
treatments),
c. Other upper airway surgery to remove obstructions related to OSA in the
previous 3 months (e.g., uvulopalatopharyngoplasty (UPPP), tonsillectomy, nasal
airway surgery),
d. 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 (excluding registries) during the
study period (5 years) with an active treatment arm that could confound the
results of the EliSA study.
11. Plan to become pregnant, currently pregnant, or breastfeeding during the
study period (5 years).
12. Vulnerable populations will not be considered for inclusion in this study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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