Obstructive Sleep ApneaB-HNSNCT06332404
Hypoglossal Nerve Stimulation Therapy in Patients With Obstructive Sleep Apnea: Belgian Registry
An observational study of Obstructive Sleep Apnea and Sleep Apnea, run by University Hospital, Antwerp at 2 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Obstructive Sleep Apnea, Sleep Apnea, Apnea
- What is being tested?
- Hypoglossal nerve stimulation Inspire system (Inspire Medical Systems Inc., USA)
- Type of treatment
- Medical device
- How many people
- 225 participants
- Where
- 2 sitesBelgium
- Study dates
- 18 Apr 2024to Apr 2034
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium2 sites, 2 recruiting
- Recruiting
AZ Sint-Jan Brugge
Bruges, West-Vlaanderen, 8000
Frederick Dochy, MD, 050 45 22 80, nok@azsintjan.be
Tom Vauterin, MD
- Recruiting
Antwerp University Hospital
Edegem, Antwerp, 2650
Dorine Van Loo, Msc, +3238215780, dorine.vanloo@uza.be
Olivier Vanderveken, MD, PhD
About this study
Official title: 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.
Read the 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).
- Conditions
- Obstructive Sleep Apnea, Sleep Apnea, Apnea
- Being tested
- Hypoglossal nerve stimulation Inspire system (Inspire Medical Systems Inc., USA)
- Keywords
- hypoglossal nerve stimulation, registry, routine clinical care
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes, Apnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypoglossal nerve stimulation Inspire system (Inspire Medical Systems Inc., USA)Device
Also called Inspire system (Inspire Medical Systems Inc., USA), Inspire device, HNS therapy
Hypoglossal nerve stimulation therapy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Hypoglossal nerve stimulation Inspire system (Inspire Medical Systems Inc., USA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
AHI is determined during a polysomnography
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: At 6, 12 and 60 months post-implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start18 Apr 2024
- Primary completionApr 2034 (estimated)
- Study completionApr 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 225 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier Vanderveken, MD, PhD, Principal investigator, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06332404
- Sponsor's protocol ID
- B3002024000047
- Acronym
- B-HNS
- Status last verified
- Apr 2025
- First submitted
- 13 Mar 2024
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypoglossal Nerve Stimulation (HNS) Therapy in Patients With Obstructive Sleep Apnea (OSA): Belgian Registry
- ClinicalTrials.gov ID
- NCT06332404
- Acronym / sponsor ID
- B-HNS / B3002024000047
- Conditions
- Obstructive Sleep Apnea, Sleep Apnea, Apnea
- Keywords
- hypoglossal nerve stimulation, registry, routine clinical care
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Study start
- 18 Apr 2024 (actual)
- Primary completion
- Apr 2034 (estimated)
- Study completion
- Apr 2034 (estimated)
- First posted
- 27 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obstructive sleep apnea (OSA) patients treated with hypoglossal nerve stimulation (HNS) therapy | – | Device: Hypoglossal nerve stimulation Inspire system (Inspire Medical Systems Inc., USA)OSA patients treated with HNS therapy will be asked to participate in the registry. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypoglossal nerve stimulation Inspire system (Inspire Medical Systems Inc., USA)Also: Inspire system (Inspire Medical Systems Inc., USA), Inspire device, HNS therapyHypoglossal nerve stimulation therapy | Device | Obstructive sleep apnea (OSA) patients treated with hypoglossal nerve stimulation (HNS) therapy |
Primary outcome
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.
9 secondary outcomes
% 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
Therapy adherence defined by the amount of hours therapy usage per night.
Time frame: At 6, 12 and 60 months post-implantation
Delta oxygen desaturation index (ODI) as measured by a polysomnography
Time frame: From baseline to 6, 12 and 60 months post-implantation
Daytime sleepiness measured by the Epworth Sleepiness Scale (ESS) questionnaire
Time frame: 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
Time frame: From baseline to 6, 12 and 60 months post-implantation
Degree of snoring measured by the Visual Analogue Scale (VAS) questionnaire
Time frame: From baseline to 6, 12 and 60 months post-implantation
Flow-derived site of collapse
Time frame: At 6, 12 and 60 months post-implantation
Pathophysiological endotypes
Time frame: At 6, 12 and 60 months post-implantation
New OSA severity metrics
Time frame: At 6, 12 and 60 months post-implantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Olivier Vanderveken, MD, PhD principal investigator
University Hospital, Antwerp
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea and Sleep Apnea, run by University Hospital, Antwerp at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dorine Van Loo, MSc (+3238215780, dorine.vanloo@uza.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delta apnea-hypopnea index (AHI) as measured by a polysomnography (time frame: From baseline to 6, 12 and 60 months post-implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.