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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypoglossal nerve stimulation Inspire system (Inspire Medical Systems Inc., USA) | Device | Hypoglossal nerve stimulation therapy |
|
| 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 |
| 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. |
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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:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dorine Van Loo, MSc | Contact | +3238215780 | dorine.vanloo@uza.be |
| Name | Affiliation | Role |
|---|---|---|
| Olivier Vanderveken, MD, PhD | University Hospital, Antwerp | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Antwerp University Hospital | Recruiting | Edegem | Antwerp | 2650 | Belgium |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
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|
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 |
| AZ Sint-Jan Brugge | Recruiting | Bruges | West-Vlaanderen | 8000 | Belgium |
|
| D012893 |
| Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |