Hypoglossal Nerve Stimulation Therapy in Patients With Obstructive Sleep Apnea: Belgian Registry
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorUniversity Hospital, Antwerp
About this trial
Hypoglossal nerve stimulation (HNS) therapy (Inspire system) is intended for the treatment of patients with moderate to severe obstructive sleep apnea (OSA) who cannot be effectively treated with the first-line treatment options. Recently, the request for reimbursement of the Inspire system in Belgium was approved.
The aim is to create a multi-center registry of OSA patients that are treated with HNS (Inspire system) within routine clinical care in Belgium.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
At least 18 years old at the time of implantation
The patient suffers from moderate to severe OSA (15 events/h ≤ AHI ≤ 65 events/h)
The patient has failed, not tolerated or has a contraindication for continuous positive airway pressure (CPAP) and/or mandibular advancement device (MAD) therapy
Absence of complete concentric collapse of the level of the soft palate during Drug-Induced Sleep Endoscopy (DISE)
Disqualifiers
Body mass index (BMI) >32 kg/m².
Combined mixed and central AHI is more than 25% of the total AHI
Patients with complete concentric collapse at the level of the soft palate or any other anatomical deviation that could impede the proper functioning of HNS
Patients with severely impaired neurological control over the upper airway
Trial population
Any patient implanted with or receiving HNS therapy in routine clinical care in Belgium and that is able to give informed consent is eligible to participate in the registry.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Hypoglossal nerve stimulation Inspire system (Inspire Medical Systems Inc., USA)
DeviceHypoglossal nerve stimulation therapy
Treatment groups
225 Participants
are divided into 1 treatment groupGroup A: Obstructive sleep apnea (OSA) patients treated with hypoglossal nerve stimulation (HNS) therapy1 intervention
Trial outcomes
Primary outcomes
1
Delta apnea-hypopnea index (AHI) as measured by a polysomnography
The AHI is an index of sleep apnea severity that encompasses the frequency of apneas (cessations in breathing) and hypopneas (reductions in airflow) per hour of sleep.
Time frame
From baseline to 6, 12 and 60 months post-implantationSecondary outcomes
1
% of patients that reach treatment success defined by a 50% reduction in AHI and an on therapy AHI of < 20 events/h OR an on therapy AHI of < 15 events/h
AHI is determined during a polysomnography
Time frame
At 6, 12 and 60 months post-implantation2
Therapy adherence defined by the amount of hours therapy usage per night.
Average hours of therapy use per night can be retrieved from data stored in the device
Time frame
At 6, 12 and 60 months post-implantation3
Delta oxygen desaturation index (ODI) as measured by a polysomnography
The ODI represents the average number of desaturation episodes (≥3%) per hour sleep and will be determined during a polysomnography.
Time frame
From baseline to 6, 12 and 60 months post-implantation4
Daytime sleepiness measured by the Epworth Sleepiness Scale (ESS) questionnaire
The ESS questionnaire assesses the probability of falling asleep in various settings and situations in daily life. This questionnaire consists of eight questions which can be scored on a four-point Likert-type scale. The lowest score (zero) suggests that the described incident is absent and the highest score (three) suggests the presence of this event. The summation of the eight items can range from 0 to 24.
Time frame
From baseline to 6, 12 and 60 months post-implantationSponsors and contacts
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Source ClinicalTrials.gov