Obstructive Sleep ApneaEURO-STIMNCT06971796
EURO-STIM Registry
An observational study of Obstructive Sleep Apnea and Obstructive Sleep Apnea (OSA), run by Inspire Medical Systems, Inc. at 21 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea, Obstructive Sleep Apnea (OSA)
- What is being tested?
- Inspire UAS System
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 21 sitesin 7 countries
- Study dates
- 26 May 2025to Apr 2035
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
21 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
21 sites in 7 countries
France6 sites, 6 recruiting
- Not yet recruiting
Angers University Hospital Center
Angers
Auregan Milena, milena.auregan@chu-angers.fr
Prof. Frédéric Gagnadoux
- Not yet recruiting
CHU Grenoble Alpes
La Tronche
Prof. Renaud Tamisier, rtamisier@chu-grenoble.fr
Prof. Renaud Tamisier
- Not yet recruiting
Clinique de la Louviere
Lille
Dr. Sarah Boulanger, sarahboulanger.pneumo@gmail.com
Dr. Sarah Boulanger
- Not yet recruiting
Hôpital d'Instruction des Armées Laveran
Marseille
Dr. Stanislas Ballivet de Regloix
Dr. Allali Laure
- Not yet recruiting
Clinique Beausoleil
Montpellier
Sarah Hammouma, s.hammouma@languedoc-mutualite.fr
Dr. Vincent Trevillot
- Not yet recruiting
CHU Saint Etienne
Saint-Priest-en-Jarez
Prof. Frederic Roche, frederic.roche@univ-st-etienne.fr
Prof. Frederic Roche
Germany6 sites, 6 recruiting
- Recruiting
Asklepios Klinik Hamburg
Hamburg
Wenke Pfenning, w.pfennig@asklepios.com
Prof. Dr. med Thomas Verse
- Recruiting
Universitatsklinikum Hamburg Eppendorf
Hamburg
Prof. Dr. med Arne Boettcher, ar.boettcher@uke.de
Prof. Dr. med Arne Boettcher
- Not yet recruiting
Klinik für HNO-Heilkunde/HNO-Schlaflabor
Lübeck
Dr. med. Armin Steffen, Armin.Steffen@uksh.de
Dr. med. Armin Steffen
- Not yet recruiting
Otto-von-Guericke-Universität Magdeburg
Magdeburg
Dr.Stephanie Kühne, stephanie.kuehne@med.ovgu.de
Dr.Stephanie Kühne
- Not yet recruiting
Universitäts-HNO-Klinik Mannheim
Mannheim
Dr. Joachim T Maurer, Joachim.Maurer@umm.de
Dr. Joachim T Maurer
- Recruiting
Klinikum Rechts der Isar Technische Universität München
Munich
Lisa Dunker, Lisa-Katharina.Dunker@mri.tum.de
Dr. Daniel Jira
United Kingdom3 sites, 3 recruiting
- Not yet recruiting
Guy's & St Thomas' NHS Foundation Trust
London
Krizzia Lammas, krizzia.lammas@gstt.nhs.uk
Prof. Joerg Steier
- Not yet recruiting
University College London Hospitals NHS Foundation Trust
London
Omursen Yildirim, omursen.yildirim@nhs.net
Ryan Chin Taw Cheong
- Not yet recruiting
Manchester University NHS Trust
Manchester
Sadie Khwaja, Sadie.khwaja@mft.nhs.uk
Sadie Khwaja
Austria2 sites, 2 recruiting
- Not yet recruiting
Klinikum Klagenfurt, KABEG
Klagenfurt
Dr. Andreas Bischof, andreas.bischof@kabeg.at
Dr. Andreas Bischof
- Not yet recruiting
Ordensklinikum Linz
Linz
Magdalena Sturm, magdalena.sturm@ordensklinikum.at
Maximilian Hartl
Netherlands2 sites, 2 recruiting
- Not yet recruiting
Sint Lucas Andreas Ziekenhus (OLVG)
Amsterdam
Anja van de Velde-Muusers, j.a.vandevelde-muusers@olvg.nl
Dr. Peter van Maanen
- Not yet recruiting
St. Antonius Ziekenhuis Nieuwegein
Nieuwegein
Dr. Marcel Copper, m.copper@antoniusziekenhuis.nl
Dr. Marcel Copper
Belgium1 site, 1 recruiting
- Not yet recruiting
Universitair Ziekenhuis Antwerpen
Edegem
Dorine Van Loo, PhD., dorine.vanloo@uza.be
Prof. Dr. Olivier Vanderveken
Switzerland1 site, 1 recruiting
- Not yet recruiting
Kantonnspital Baselland-Liestal
Liestal
Prof. Dr. Kurt Tschopp, kurt.tschopp@ksbl.ch
Prof. Dr. Kurt Tschopp
About this study
Official title: Longitudinal Outcomes and Adherence of the Inspire System, 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.
- Being tested
- Inspire UAS System
- Keywords
- Sleep Apnea, OSA, Inspire, Obstructive Sleep Apnea
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspire UAS SystemDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea Hypopnea Index (AHI)
The AHI, or number of apnea and hypopnea events per hour, is a measure of OSA severity.
Measured: 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.
Measured: ESS will be collected at baseline and follow-up visits, if available, as determined by clinical standard of care.
Secondary outcomes (6)
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.
Measured: DISE VOTE Score will be collected, if available, at baseline.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start26 May 2025
- Primary completionApr 2035 (estimated)
- Study completionApr 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Inspire Medical Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06971796
- Sponsor's protocol ID
- 2023-004
- Acronym
- EURO-STIM
- Status last verified
- Apr 2025
- First submitted
- 7 Apr 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Outcomes and Adherence of the Inspire System, EURO-STIM Registry
- ClinicalTrials.gov ID
- NCT06971796
- Acronym / sponsor ID
- EURO-STIM / 2023-004
- Keywords
- Sleep Apnea, OSA, Inspire, Obstructive Sleep Apnea
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Inspire Medical Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 May 2025 (actual)
- Primary completion
- Apr 2035 (estimated)
- Study completion
- Apr 2035 (estimated)
- First posted
- 14 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inspire UAS SystemParticipants 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. | Device | – |
Primary outcome
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.
6 secondary outcomes
DISE VOTE Classification
Time frame: DISE VOTE Score will be collected, if available, at baseline.
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.
Patient Experience with Therapy (PET)
Time frame: PET will be collected at follow-up visits after device activation, if available.
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.
Therapy Use
Time frame: Therapy use will be collected at follow-up visits after device activation, if available.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
21 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea and Obstructive Sleep Apnea (OSA), run by Inspire Medical Systems, Inc. at 21 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in France, Germany, United Kingdom, Austria, Netherlands and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elyse Ebeling ((763) 250-9432, elyseebeling@inspiresleep.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.