Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The registry is to measure longitudinal outcomes and adherence of the Inspire System. The goal of the registry is to capture the life cycle of the patient's use of the Inspire System through routine clinical care visits. There are no required interventions or testing.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inspire UAS System | Device | Participants will be implanted with the Inspire UAS System, which is a permanent, implantable therapy that consists of three implantable components: an IPG, a stimulation lead, and a sensing lead. In addition, the study subject receives a remote control to activate the therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Apnea Hypopnea Index (AHI) | The AHI, or number of apnea and hypopnea events per hour, is a measure of OSA severity. | Total AHI, supine and non-supine AHI, documented as events/hour of sleep will be collected at baseline, prior to implant, and at follow-up visits, if available, as determined by clinical standard of care. |
| Epworth Sleepiness Scale (ESS) | The ESS is a validated, self-report instrument that rates a subject's tendency to fall asleep in eight common daily situations13. The ESS has been validated primarily in OSA. | ESS will be collected at baseline and follow-up visits, if available, as determined by clinical standard of care. |
| Measure | Description | Time Frame |
|---|---|---|
| DISE VOTE Classification | A Drug-Induced Sleep Endoscopy (DISE) is a diagnostic, standard of care procedure performed as part of the evaluation for airway surgeries (including implant of the Inspire System). The DISE is utilized to visualize the patient's airway obstruction. | DISE VOTE Score will be collected, if available, at baseline. |
Not provided
Inclusion Criteria:
Any patient implanted with or receiving an Inspire implant, who meets the following criteria, is eligible to participate in the registry:
Exclusion Criteria:
Any patient who meets any of the following criteria will not be eligible to participate in the registry:
Not provided
Not provided
Not provided
Patients previously implanted or scheduled to be implanted with an Inspire System will be informed of the registry and given the option to participate by qualified Euro-Stim Registry staff. Up to 1,000 patients at up to 55 centers in multiple countries in the European Union and the United Kingdom will be included in the registry.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elyse Ebeling | Contact | (763) 250-9432 | elyseebeling@inspiresleep.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Klagenfurt, KABEG | Not yet recruiting | Klagenfurt | Austria |
Not provided
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
Not provided
Not provided
Not provided
Not provided
Not provided
| Functional Outcomes of Sleep Questionnaire (FOSQ-30) |
The FOSQ-30 is a validated, quality of life measurement that assesses the effect of a subject's daytime sleepiness on activities of ordinary living. It is commonly used in the clinical evaluation and management of OSA. |
| FOSQ-30 will be collected at baseline and follow-up visits, if available and only if already collected as part of routine clinical care. |
| Patient Experience with Therapy (PET) | The PET is a survey designed to collect information about patient's experience with the Inspire therapy. | PET will be collected at follow-up visits after device activation, if available. |
| Maintenance of Wakefulness Test (MWT) | The maintenance of wakefulness test is used to measure a person's ability to stay awake during a defined period of time. | Sleep latency is recorded in minutes and may be collected from a maintenance of wakefulness test performed at baseline and follow-up visits after device activation, if available. |
| Therapy Use | Therapy use, reported as hours of use per week, is recorded during follow-up visits and will be collected from the Inspire physician programmer. | Therapy use will be collected at follow-up visits after device activation, if available. |
| Adverse Events | Both serious and non-serious procedure-related and device/therapy related adverse events will be collected and reported. | The number of events (as well as the % of subjects in which the event occurred) will be reported at implant and at follow-up timepoints. |
| Ordensklinikum Linz | Not yet recruiting | Linz | Austria |
|
| Universitair Ziekenhuis Antwerpen | Not yet recruiting | Edegem | Belgium |
|
| Angers University Hospital Center | Not yet recruiting | Angers | France |
|
| CHU Grenoble Alpes | Not yet recruiting | La Tronche | France |
|
| Clinique de la Louviere | Not yet recruiting | Lille | France |
|
| Hôpital d'Instruction des Armées Laveran | Not yet recruiting | Marseille | France |
|
| Clinique Beausoleil | Not yet recruiting | Montpellier | France |
|
| CHU Saint Etienne | Not yet recruiting | Saint-Priest-en-Jarez | France |
|
| Asklepios Klinik Hamburg | Recruiting | Hamburg | Germany |
|
| Universitatsklinikum Hamburg Eppendorf | Recruiting | Hamburg | Germany |
|
| Klinik für HNO-Heilkunde/HNO-Schlaflabor | Not yet recruiting | Lübeck | Germany |
|
| Otto-von-Guericke-Universität Magdeburg | Not yet recruiting | Magdeburg | Germany |
|
| Universitäts-HNO-Klinik Mannheim | Not yet recruiting | Mannheim | Germany |
|
| Klinikum Rechts der Isar Technische Universität München | Recruiting | Munich | Germany |
|
| Sint Lucas Andreas Ziekenhus (OLVG) | Not yet recruiting | Amsterdam | Netherlands |
|
| St. Antonius Ziekenhuis Nieuwegein | Not yet recruiting | Nieuwegein | Netherlands |
|
| Kantonnspital Baselland-Liestal | Not yet recruiting | Liestal | Switzerland |
|
| Guy's & St Thomas' NHS Foundation Trust | Not yet recruiting | London | United Kingdom |
|
| University College London Hospitals NHS Foundation Trust | Not yet recruiting | London | United Kingdom |
|
| Manchester University NHS Trust | Not yet recruiting | Manchester | United Kingdom |
|
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |