An observational study in Obstructive Sleep Apnea, Sleep Apnea and Apnea, sponsored by University Hospital, Antwerp. Recruiting at 2 sites in Belgium. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2025-09-15.
Sponsored by University Hospital, Antwerp · Observational
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.
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).
2,240 studies on the registry are indexed under Sleep Apnea, Obstructive; 475 are open to participants now.
This study's planned enrollment of 225 is above the median of 105 across 666 observational studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →University Hospital, Antwerp is the lead sponsor of 242 studies on the registry; 66 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Any patient implanted with or receiving the Inspire HNS system and who is able to give is eligible to participate in the registry. A patient is eligible for HNS implantation if he/she meets the following criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Also known as: Inspire system (Inspire Medical Systems Inc., USA), Inspire device, HNS therapy
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.
Time frame: From baseline to 6, 12 and 60 months post-implantation
% 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
Time frame: 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
Time frame: 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.
Time frame: 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.
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
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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: At 6, 12 and 60 months post-implantation
Started Apr 2024 (actual). Primary completion is estimated for Apr 2034, 120 months after the start.
Of 258 non-industry observational studies under Sleep Apnea, Obstructive, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 61. This study's planned 120 months is above that.
Counting every sponsor, half of 294 studies reached it within 28 months; a quarter within 14 and three quarters within 63.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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