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

Last updated: September 12, 2025
Sponsor: University Hospital, Antwerp
Overall Status: Active - Recruiting

Phase

N/A

Condition

Sleep Disorders

Sleep Apnea Syndromes

Treatment

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

Clinical Study ID

NCT06332404
B3002024000047
  • Ages 18-99
  • All Genders

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 Criteria

Inclusion

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 continuouspositive airway pressure (CPAP) and/or mandibular advancement device (MAD) therapy

  • Absence of complete concentric collapse of the level of the soft palate duringDrug-Induced Sleep Endoscopy (DISE)

Exclusion

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 anyother 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.

Study Design

Total Participants: 225
Treatment Group(s): 1
Primary Treatment: Hypoglossal nerve stimulation Inspire system (Inspire Medical Systems Inc., USA)
Phase:
Study Start date:
April 18, 2024
Estimated Completion Date:
April 30, 2034

Study 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).

Connect with a study center

  • Antwerp University Hospital

    Edegem, Antwerp 2650
    Belgium

    Site Not Available

  • Antwerp University Hospital

    Edegem 2799007, Antwerp 2650
    Belgium

    Active - Recruiting

  • AZ Sint-Jan Brugge

    Bruges 2800931, West-Vlaanderen 8000
    Belgium

    Active - Recruiting

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