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NCT Number: NCT06332404

Hypoglossal Nerve Stimulation Therapy in Patients With Obstructive Sleep Apnea: 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.

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Key information

Conditions

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

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Antwerp University Hospital, Edegem, Antwerp, Belgium

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Device

Hypoglossal nerve stimulation therapy

Other names: Inspire system (Inspire Medical Systems Inc., USA), Inspire device, HNS therapy

Primary outcomes

  1. Delta apnea-hypopnea index (AHI) as measured by a polysomnography

    Time frame: 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.

Secondary outcomes

  1. % 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

    Time frame: At 6, 12 and 60 months post-implantation

    AHI is determined during a polysomnography

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

    Time frame: At 6, 12 and 60 months post-implantation

    Average hours of therapy use per night can be retrieved from data stored in the device

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

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

    The ODI represents the average number of desaturation episodes (≥3%) per hour sleep and will be determined during a polysomnography.

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

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

    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.

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

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

    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.

  6. Degree of snoring measured by the Visual Analogue Scale (VAS) questionnaire

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

    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

  7. Flow-derived site of collapse

    Time frame: At 6, 12 and 60 months post-implantation

    Several parameters extracted from the flow signal, including negative effort dependence (NED), peak inspiratory flow, etc. measured during routine polysomnography

  8. Pathophysiological endotypes

    Time frame: At 6, 12 and 60 months post-implantation

    Changes in pathophysiological traits (Vpassive, Vactive, Arousal Threshold, Loop Gain) will be quantified as %Veupnea from polysomnography data using a validated algorithm.

  9. New OSA severity metrics

    Time frame: At 6, 12 and 60 months post-implantation

    Change in sleep apnea specific hypoxic burden (SASHB), delta heart rate and pulse wave amplitude drops.

Study contacts

Contact information is provided by the study sponsor or research team.

Dorine Van Loo, MSc

CONTACT

[email protected]

+3238215780

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Registry information

Official study title

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

Acronym: B-HNS

Important dates

Study start
2024
Primary completion
2034
Study completion
2034
First posted
Mar 27, 2024
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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