Longitudinal Outcomes and Adherence of the Inspire System, EURO-STIM Registry
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 1,000
- Locations
- 21
- Primary Endpoint
- Apnea Hypopnea Index (AHI)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Any patient implanted with or receiving an Inspire implant, who meets the following criteria, is eligible to participate in the registry:
- •Capable of giving informed consent, as required per institution
- •Willing to return for routine clinic visits as required for Inspire therapy management
Exclusion Criteria
- •Any patient who meets any of the following criteria will not be eligible to participate in the registry:
- •Has a life expectancy of less than one year
- •Any reason the clinician deems patient is unfit for participation in the study
Outcomes
Primary Outcomes
Apnea Hypopnea Index (AHI)
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.
The AHI, or number of apnea and hypopnea events per hour, is a measure of OSA severity.
Epworth Sleepiness Scale (ESS)
Time Frame: ESS will be collected at baseline and follow-up visits, if available, as determined by clinical standard of care.
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.
Secondary Outcomes
- DISE VOTE Classification(DISE VOTE Score will be collected, if available, at baseline.)
- Functional Outcomes of Sleep Questionnaire (FOSQ-30)(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)(PET will be collected at follow-up visits after device activation, if available.)
- Maintenance of Wakefulness Test (MWT)(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 will be collected at follow-up visits after device activation, if available.)
- Adverse Events(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.)