Ireland
--:--IST
Recruiting Observational

Hypoglossal Nerve Stimulation Therapy in Patients With Obstructive Sleep Apnea: Belgian Registry

NCT06332404 · tracked via the Priya Life Science Belgium tracker
Phase
Observational
Started
2024-04-18
Last updated
2025-09-15

Condition(s) studied

Obstructive Sleep ApneaSleep ApneaApnea

Investigational drug(s) / intervention(s)

Hypoglossal nerve stimulation Inspire system (Inspire Medical Systems Inc., USA)

Hypoglossal nerve stimulation Inspire system (Inspire Medical Systems Inc., USA): Hypoglossal nerve stimulation therapy

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
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 outcome measure(s)

  • Delta apnea-hypopnea index (AHI) as measured by a polysomnography — From baseline to 6, 12 and 60 months post-implantation
    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.

Trial sites (2)

FacilityCityRegionStatus
Antwerp University Hospital Edegem Antwerp Recruiting
AZ Sint-Jan Brugge Bruges West-Vlaanderen Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06332404 on ClinicalTrials.gov ↗ ← All trials in Belgium