The primary objective of this study is to confirm the safety and clinical effectiveness of the Genio® system in moderate to severe Obstructive Sleep Apnea (OSA) adult patients over a period of 5 years post-surgery.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Obstructive Sleep Apnea disorders
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Safety Endpoint:
Safety will be assessed to track the long-term safety of the Genio® System
according to the Genio® System Post Marketing Surveillance Plan.
Safety will be evaluated by the incidence of device-related SAEs recorded
during the study for a period of 12 months post-surgery. No formal statistical
hypothesis will be tested as part of the safety assessment.
Safety evaluation will be done both at local (by Investigator) and central
level (supported by an independent Clinical Events Committee (CEC)).
Co-Primary Effectiveness Endpoints:
Effectiveness will be assessed to track the performance of the Genio® System
according to the Genio® System Post Marketing Surveillance Plan.
• Change in AHI from baseline to 12 months post-surgery
• Change in the quality of life measured by the Functional Outcomes of Sleep
Questionnaire (FOSQ-10) from baseline to 12 months post-surgery
Secondary outcome
• Change in ODI from baseline to 12 months post-surgery
• Change in the percentage of sleep time at SaO2 < 90% from baseline to 12
months post-surgery
• Change in the quality of life measured by the Symptoms of Nocturnal
Obstruction and Related Events (SNORE-25) questionnaire from baseline to 12
months post-surgery
• Change in daytime sleepiness measured by the ESS questionnaire from baseline
to 12 months post-surgery
• Change in AHI from baseline to 2-, 3-, 4- and 5-years post-surgery
• Change in ODI from baseline to 2-, 3-, 4- and 5-years post-surgery
• Change in the percentage of sleep time at SaO2 < 90% from baseline to 2-, 3-,
4- and 5-years post-surgery
• Change in OSA-specific quality of life measured by the FOSQ-10 questionnaire
from baseline to 2-, 3-, 4- and 5-years post-surgery
• Change in OSA-specific quality of life measured by SNORE-25 questionnaire
from baseline to 2-, 3-, 4- and 5-years post-surgery
• Change in daytime sleepiness measured by the ESS questionnaire from baseline
to 2-, 3-, 4- and 5-years post-surgery
• Compliance in device usage over time through completion of a patient diary
Background summary
OSA is a respiratory sleep disorder characterized by recurrent episodes of
partial (hypopnea) or complete (apnea) obstructions of the upper airway.
These obstructions caused by the relaxation and gradual collapse of
the pharyngeal muscles, result in reductions or cessations of the
respiratory airflow and therefore, in blood oxygen desaturations.
The largest upper airway dilator muscle is the genioglossus muscle, one of the
different tongue muscles, and is responsible for forward tongue movement and
stiffening of the anterior pharyngeal wall. In people with OSA, the
neuromuscular activity of the genioglossus muscle is decreased
compared to normal individuals, accounting for insufficient response and
contraction to open the airway. This important factor contributes to airway
obstruction; the pharyngeal muscles relax, gradually obstruct the airway, and
can completely block or significantly restrict air flow.
OSA is the most common sleep disorder and is associated with major
comorbidities. The gold standard diagnosis method for OSA is the overnight PSG
that monitors many body functions during sleep such as brain activity
(Electroencephalogram [EEG]), heart rhythm (Electrocardiogram [ECG]), muscle
activation (Electromyogram [EMG]), eye movement (Electrooculogram [EOG]),
oxygen level (oximetry), snoring intensity, and respiratory flow and effort.
In OSA patients, airway obstruction events occur several times during the
night. These obstruction events consist of apneas and hypopneas and lead to a
gradual decrease of oxygen levels in the blood, which in turn results in a
decrease of heart rate. Arousals occur in the setting of hypoxemia.
These arousals are registered by the EEG and show that the brain awakes from
any stage of sleep to a short arousal. At this time, there is a conscious
breath or gasp, which resolves the episode. An increase in sympathetic
tone activity mediated through the release of hormones such as epinephrine and
noradrenaline occurs. As a result of the increase in sympathetic tone, the
heart enlarges in attempt to pump more blood and increase the blood pressure
and heart rate.
These repeated arousals combined with repeated hypoxemia leaves the
patient sleep deprived, which leads to daytime somnolence and worsens
cognitive function. This cycle can repeat itself hundreds of times per
night in patients with severe OSA. These repeated fluctuations in
sympathetic tone and nocturnal episodes of elevated blood pressure
night may evolve into sustained hypertension. Elevated high blood
pressure and increased heart rate can in turn result in other diseases. The
Oxygen Desaturation Index (ODI) is a commonly used metric used to assess the
severity of OSA and is defined, according to the 2014 recommended guidelines
from the American Academy of Sleep Medicine (AASM), as the number of times per
hour of sleep that the blood's oxygen level drop by at least 3% from baseline.
Apnea-Hypopnea index (AHI) is a standard common measure used to assess
the severity of OSA that corresponds to the average number of episodes of
apnea and hypopnea per hour of sleep. An apnea event is defined as a breathing
cessation (>=90% airflow decrease) lasting 10 seconds or more. A hypopnea event
is defined as an airflow decrease >=30% for > 10 seconds and >=3% desaturation or
arousal. AHI severity is classified as 5-15, 15-30, and >30 events/hour
indicating mild, moderate and severe levels of OSA respectively.
Study objective
The primary objective of this study is to confirm the safety and clinical
effectiveness of the Genio® system in moderate to severe Obstructive Sleep
Apnea (OSA) adult patients over a period of 5 years post-surgery.
Study design
This study is a multicenter, prospective, single arm, non-randomized,
post-market study.
Duration of the study is expected to take up to 8.5 years. Recruitment phase is
expected to take between 30 and 42 months and each patient will be followed for
safety and effectiveness for 5 years post-surgery. The primary outcomes will be
assessed at 12 months, but treatment effects, and safety will be evaluated for
an additional 4 year period.
A patient is considered to have completed the study if they have completed the
last visit, 5 years post-surgery.
The study will be completed once the last patient in (LPI) will have
successfully reached the 5 years follow up period.
Intervention
All eligible patients will be implanted with the Genio system and therapy will
be individually optimized.
Study burden and risks
It is expected that patients will experience an improvement in their sleep
apnea after device activation.
Patients participating in the study will be required to come at the hospital
for screening activities. If they are eligible, they will then come for the
surgery, the device activation and follow up visits including setup for home
PSGs (at 5 visits). At 7 visits in total, they should complete OSA
questionnaires (FOSQ-10, ESS, and SNORE-25). They will also complete the
Patient Usability and Patient Satisfaction questionnaires 8 and 5 times
respectively. In addition, patient diary should be completed daily from the
activation of the device up to 12 months post-surgery. They will also receive 4
phone calls of about 15 minutes to assess their general wellbeing including
collection of any emerging AEs.
Rue Edouard Belin 12
Mont-Saint-Guibert 1435
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Rue Edouard Belin 12
Mont-Saint-Guibert 1435
BE
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT04031040 |
| CCMO | NL70641.100.19 |