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

NCT06332404 | Recruiting FDA Device

• 1 other identifier: B3002024000047
• Study Type: observational
• Target: 225
• Locations: 1 country
• Sites: 2

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.

Conditions

Obstructive Sleep Apnea; Sleep Apnea; Apnea

Keywords

hypoglossal nerve stimulation; registry; routine clinical care

Outcome Measures

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.

  From baseline to 6, 12 and 60 months post-implantation

Secondary Outcomes (9)

• % 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

  At 6, 12 and 60 months post-implantation

• Therapy adherence defined by the amount of hours therapy usage per night.

  At 6, 12 and 60 months post-implantation

• Delta oxygen desaturation index (ODI) as measured by a polysomnography

  From baseline to 6, 12 and 60 months post-implantation

• Daytime sleepiness measured by the Epworth Sleepiness Scale (ESS) questionnaire

  From baseline to 6, 12 and 60 months post-implantation

• Disease-specific quality of life as measured by the Functional Outcomes of Sleep Questionnaire-30 (FOSQ-30) questionnaire

  From baseline to 6, 12 and 60 months post-implantation

Study Arms (1)

Obstructive sleep apnea (OSA) patients treated with hypoglossal nerve stimulation (HNS) therapy

OSA patients treated with HNS therapy will be asked to participate in the registry.

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

Interventions

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

Hypoglossal nerve stimulation therapy

Also known as: Inspire system (Inspire Medical Systems Inc., USA), Inspire device, HNS therapy

Obstructive sleep apnea (OSA) patients treated with hypoglossal nerve stimulation (HNS) therapy

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Antwerp: lead

Study Sites (2)

Antwerp University Hospital

Edegem, Antwerp, 2650, Belgium

RECRUITING

AZ Sint-Jan Brugge

Bruges, West-Vlaanderen, 8000, Belgium

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Apnea

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Olivier Vanderveken, MD, PhD

  University Hospital, Antwerp

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dorine Van Loo, MSc

CONTACT

+3238215780; dorine.vanloo@uza.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: March 27, 2024
• Study Start: April 18, 2024
• Primary Completion (Estimated): April 1, 2034
• Study Completion (Estimated): April 1, 2034
• Last Updated: September 15, 2025

Record last verified: 2025-04

Locations

BE (2)