Hypoglossal Nerve Stimulation Therapy in Patients With Obstructive Sleep Apnea: Belgian Registry (B-HNS)

Hypoglossal Nerve Stimulation (HNS) Therapy in Patients With Obstructive Sleep Apnea (OSA): Belgian Registry

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.

Study Overview

• Status: Recruiting
• Conditions: Apnea; Obstructive Sleep Apnea; Sleep Apnea
• Intervention / Treatment: Device: Hypoglossal nerve stimulation Inspire system (Inspire Medical Systems Inc., USA)

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).

• Study Type: Observational
• Enrollment (Estimated): 225

Contacts and Locations

• Study Contact: Name: Dorine Van Loo, Msc; Phone Number: +3238215780; Email: dorine.vanloo@uza.be

Study Locations

• Belgium
  • Antwerp
    • Edegem, Antwerp, Belgium, 2650
      • Recruiting
      • Antwerp University Hospital
      • Principal Investigator: Olivier Vanderveken, MD, PhD
      • Contact: Dorine Van Loo, Msc; Phone Number: +3238215780; Email: dorine.vanloo@uza.be
  • West-Vlaanderen
    • Bruges, West-Vlaanderen, Belgium, 8000
      • Recruiting
      • AZ Sint-Jan Brugge
      • Contact: Frederick Dochy, MD; Phone Number: 050 45 22 80; Email: nok@azsintjan.be
      • Principal Investigator: Tom Vauterin, MD
      • Sub-Investigator: Frederick Dochy, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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); Hypoglossal nerve stimulation therapy; Other Names: Inspire system (Inspire Medical Systems Inc., USA); Inspire device; HNS therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
% 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	At 6, 12 and 60 months post-implantation
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	At 6, 12 and 60 months post-implantation
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.	From baseline to 6, 12 and 60 months post-implantation
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.	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	The FOSQ-30 is a disease-specific quality of life questionnaire that determines functional status in adults; measures are designed to assess the impact of disorders of excessive sleepiness on multiple activities of everyday living and the extent to which these abilities are improved by effective treatment.	From baseline to 6, 12 and 60 months post-implantation
Degree of snoring measured by the Visual Analogue Scale (VAS) questionnaire	Snoring intensity is evaluated using a 10 cm visual analogue scale (VAS) from 0 to 10: 0 represents no snoring, 1-3 represents minimally annoying, 4-6 represents moderately annoying, 7-9 represents annoying, and 10 represents extremely annoying	From baseline to 6, 12 and 60 months post-implantation
Flow-derived site of collapse	Several parameters extracted from the flow signal, including negative effort dependence (NED), peak inspiratory flow, etc. measured during routine polysomnography	At 6, 12 and 60 months post-implantation
Pathophysiological endotypes	Changes in pathophysiological traits (Vpassive, Vactive, Arousal Threshold, Loop Gain) will be quantified as %Veupnea from polysomnography data using a validated algorithm.	At 6, 12 and 60 months post-implantation
New OSA severity metrics	Change in sleep apnea specific hypoxic burden (SASHB), delta heart rate and pulse wave amplitude drops.	At 6, 12 and 60 months post-implantation

Collaborators and Investigators

• Sponsor: University Hospital, Antwerp
• Investigators: Principal Investigator: Olivier Vanderveken, MD, PhD, University Hospital, Antwerp

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2024
• Primary Completion (Estimated): April 1, 2034
• Study Completion (Estimated): April 1, 2034

Study Registration Dates

• First Submitted: March 13, 2024
• First Submitted That Met QC Criteria: March 25, 2024
• First Posted (Actual): March 27, 2024

Study Record Updates

• Last Update Posted (Estimated): September 15, 2025
• Last Update Submitted That Met QC Criteria: September 12, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: registry; hypoglossal nerve stimulation; routine clinical care
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Disorders, Intrinsic; Dyssomnias; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: B3002024000047

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No