Clinical trial NCT06332404: Hypoglossal Nerve Stimulation Therapy in Patients With Obstructive Sleep Apnea: Belgian Registry
Official title: Hypoglossal Nerve Stimulation (HNS) Therapy in Patients With Obstructive Sleep Apnea (OSA): Belgian Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obstructive Sleep Apnea
Sleep Apnea
Apnea
Keywords: hypoglossal nerve stimulation
registry
routine clinical care
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
First posted: 2024-03-27
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study 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.

Brief summary: 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.

Detailed description: Patients that are implanted with the Inspire system in Belgium will be invited to participate in the registry. Data will be collected from different routine clinical care visits over a period of 5 years post-implantation. All assessments of the registry are part of the standard clinical care. Data collection will include polysomnographic data, home sleep test data, therapy usage, device data and questionnaires (Epworth Sleepiness Scale, Functional Outcomes of Sleep Questionnaire-30, Visual Analogue Scale (VAS) snoring.

Data will be collected from routine visits including: pre-implant, implant, activation, titration, follow-up (6, 12, 24, 36, 48 and 60 months post-implantation).

Eligibility criteria: Inclusion Criteria:

Any patient implanted with or receiving the Inspire HNS system and who is able to give informed consent is eligible to participate in the registry. A patient is eligible for HNS implantation if he/she meets the following criteria:

* 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)

Exclusion Criteria:

* 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
* Pregnancy
* Surgery performed on the soft palate in the past three months before implantation.

Primary outcomes:
measure: Delta apnea-hypopnea index (AHI) as measured by a polysomnography
timeFrame: From baseline to 6, 12 and 60 months post-implantation
Secondary outcomes:
measure: % 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
timeFrame: At 6, 12 and 60 months post-implantation
measure: Therapy adherence defined by the amount of hours therapy usage per night.
timeFrame: At 6, 12 and 60 months post-implantation
measure: Delta oxygen desaturation index (ODI) as measured by a polysomnography
timeFrame: From baseline to 6, 12 and 60 months post-implantation
measure: Daytime sleepiness measured by the Epworth Sleepiness Scale (ESS) questionnaire
timeFrame: From baseline to 6, 12 and 60 months post-implantation
measure: Disease-specific quality of life as measured by the Functional Outcomes of Sleep Questionnaire-30 (FOSQ-30) questionnaire
timeFrame: From baseline to 6, 12 and 60 months post-implantation
measure: Degree of snoring measured by the Visual Analogue Scale (VAS) questionnaire
timeFrame: From baseline to 6, 12 and 60 months post-implantation
measure: Flow-derived site of collapse
timeFrame: At 6, 12 and 60 months post-implantation
measure: Pathophysiological endotypes
timeFrame: At 6, 12 and 60 months post-implantation
measure: New OSA severity metrics
timeFrame: At 6, 12 and 60 months post-implantation
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Antwerp University Hospital
state: Antwerp
Study officials:
affiliation: University Hospital, Antwerp
name: Olivier Vanderveken, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: