Clinical trial NCT06971796: EURO-STIM Registry
Official title: Longitudinal Outcomes and Adherence of the Inspire System, EURO-STIM Registry
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Obstructive Sleep Apnea
Obstructive Sleep Apnea (OSA)
Keywords: Sleep Apnea
OSA
Inspire
Obstructive Sleep Apnea
Lead sponsor: Inspire Medical Systems, Inc.
Sponsor class: INDUSTRY
First posted: 2025-05-14
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

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.


Eligibility criteria: Inclusion Criteria:

Any patient implanted with or receiving an Inspire implant, who meets the following criteria, is eligible to participate in the registry:

1. Capable of giving informed consent, as required per institution
2. 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:

1. Has a life expectancy of less than one year
2. Any reason the clinician deems patient is unfit for participation in the study

Primary outcomes:
measure: Apnea Hypopnea Index (AHI)
timeFrame: 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.
measure: Epworth Sleepiness Scale (ESS)
timeFrame: ESS will be collected at baseline and follow-up visits, if available, as determined by clinical standard of care.
Secondary outcomes:
measure: DISE VOTE Classification
timeFrame: DISE VOTE Score will be collected, if available, at baseline.
measure: Functional Outcomes of Sleep Questionnaire (FOSQ-30)
timeFrame: FOSQ-30 will be collected at baseline and follow-up visits, if available and only if already collected as part of routine clinical care.
measure: Patient Experience with Therapy (PET)
timeFrame: PET will be collected at follow-up visits after device activation, if available.
measure: Maintenance of Wakefulness Test (MWT)
timeFrame: 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.
measure: Therapy Use
timeFrame: Therapy use will be collected at follow-up visits after device activation, if available.
measure: Adverse Events
timeFrame: 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.
Other outcomes:
Locations:
Study officials:
References: