EURO-STIM Registry
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInspire Medical Systems, Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Capable of giving informed consent, as required per institution
Willing to return for routine clinic visits as required for Inspire therapy management
Disqualifiers
Has a life expectancy of less than one year
Any reason the clinician deems patient is unfit for participation in the study
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Inspire UAS System
DeviceParticipants 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Apnea Hypopnea Index (AHI)
The AHI, or number of apnea and hypopnea events per hour, is a measure of OSA severity.
Time frame
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.2
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.
Time frame
ESS will be collected at baseline and follow-up visits, if available, as determined by clinical standard of care.Secondary outcomes
1
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.
Time frame
DISE VOTE Score will be collected, if available, at baseline.2
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.
Time frame
FOSQ-30 will be collected at baseline and follow-up visits, if available and only if already collected as part of routine clinical care.3
Patient Experience with Therapy (PET)
The PET is a survey designed to collect information about patient's experience with the Inspire therapy.
Time frame
PET will be collected at follow-up visits after device activation, if available.4
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.
Time frame
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov