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NCT Number: NCT06971796

EURO-STIM Registry

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.

Recruiting

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Obstructive Sleep Apnea (OSA) Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinikum Klagenfurt, KABEG, Klagenfurt, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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

  1. DISE VOTE Classification

    Time frame: DISE VOTE Score will be collected, if available, at baseline.

    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.

  2. Functional Outcomes of Sleep Questionnaire (FOSQ-30)

    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.

    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.

  3. Patient Experience with Therapy (PET)

    Time frame: PET will be collected at follow-up visits after device activation, if available.

    The PET is a survey designed to collect information about patient's experience with the Inspire therapy.

  4. Maintenance of Wakefulness Test (MWT)

    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.

    The maintenance of wakefulness test is used to measure a person's ability to stay awake during a defined period of time.

  5. Therapy Use

    Time frame: Therapy use will be collected at follow-up visits after device activation, if available.

    Therapy use, reported as hours of use per week, is recorded during follow-up visits and will be collected from the Inspire physician programmer.

  6. Adverse Events

    Time frame: 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.

    Both serious and non-serious procedure-related and device/therapy related adverse events will be collected and reported.

Study contacts

Contact information is provided by the study sponsor or research team.

Elyse Ebeling

CONTACT

[email protected]

(763) 250-9432

Sponsors and collaborators

Lead sponsor

Inspire Medical Systems, Inc.

Industry

Registry information

Official study title

Longitudinal Outcomes and Adherence of the Inspire System, EURO-STIM Registry

Acronym: EURO-STIM

Important dates

Study start
2025
Primary completion
2035
Study completion
2035
First posted
May 14, 2025
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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