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Obstructive Sleep ApneaPhase 4NCT02293746

Inspire® Upper Airway Stimulation (UAS) System German Post-Market Study

A Phase 4 study testing Inspire® Upper Airway Stimulation (UAS) System in people with Obstructive Sleep Apnea, run by Inspire Medical Systems, Inc. at 3 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to obtain additional safety and efficacy data on the use of Inspire® therapy for the treatment of subjects with moderate to severe Obstructive Sleep Apnea. Read more about this study

Who is it for?
Ages 21 years and olderHealthy volunteers can take part
Conditions the study is for
Obstructive Sleep Apnea
What is being tested?
Inspire® Upper Airway Stimulation (UAS) System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
3 sitesGermany
Study dates
Jun 2014to 9 Jan 2017
Phase
Phase 4
Are there results?
None posted in the registry

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 21 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Likely suffer moderate-to-severe OSA based on history and physical, or have an established diagnosis of OSA (≥ 15 AHI<65) based on a prior sleep test
  • Willing and capable to have stimulation hardware permanently implanted, and to use the patient programmer to activate the stimulation
  • Willing and capable to return for all follow-up visits and conduct sleep studies at home, including the evaluation procedures and filling out questionnaires
  • Willing and capable of providing informed consent

Who cannot join

  • Contraindications
  • Any anatomical finding that would compromise the performance of upper airway stimulation, such as the presence of complete concentric collapse of the soft palate
  • Have any condition or procedure that has compromised neurological control of the upper airway
  • Unable or do not have the necessary assistance to operate the patient programmer
  • Pregnant or plan to become pregnant
  • Require magnetic resonance imaging (MRI)
Show all 14Show fewer
  • Have an implantable device that may be susceptible to unintended interaction with the Inspire system.
  • Additional exclusions for study purposes only:
  • Body Mass Index (BMI) of > 35
  • Central + mixed apneas > 25% of the total apnea-hypopnea index (AHI)
  • Any chronic medical illness or condition that contraindicates a surgical procedure under general anesthesia, as judged by the clinical study Investigator
  • Has a terminal illness with life expectancy < 12 months
  • Active psychiatric disease (psychotic illness, major depression, or acute anxiety attacks) which prevents subject compliance with the requirements of the investigational study testing
  • Any other reason the investigator deems subject is unfit for participation in the study

Trial locations and contacts

3 sites in 1 country.

Germany3 sites

  • Klinik für HNO-Heilkunde/HNO-Schlaflabor

    Lübeck, 23538

  • Universitäts-HNO-Klinik Mannheim

    Mannheim, D-68135

  • Klinikum rechts der Isar der Technischen Universität München

    München, D-81675

Other trials in Germany

About this study

Official title: Inspire® Upper Airway Stimulation (UAS) System German Post-Market Study: CE Certificate Number 562872

The purpose of this study is to obtain additional safety and efficacy data on the use of Inspire® therapy for the treatment of subjects with moderate to severe Obstructive Sleep Apnea.

Read the detailed description

This is a multi-center, prospective, single-arm study conducted under a common implant and follow-up protocol. Each subject will serve as their own control.

The study will collect pre-operative two-night home sleep testing, medical history and subject quality of life measures. Intra- and post- operative procedure data will be collected. Therapy usage and device adjustment data, as well as a subject satisfaction with therapy survey, will be collected for additional analysis.

Post-implant, procedure- and device-related events, QoL questionnaires, therapy usage and device adjustment data will be collected. Sleep study data will collected during the 2-month visit and, if conducted, a 3-month visit using a single night in-lab titration PSGs At 6 and 12 months post-implant, 2-night home sleep testing will be completed. Safety data will be collected throughout the study. Subjects will be exited from the study following the 12-month visits.

The subject population will consist of otherwise healthy men and women that are at least 21 years old and have: 1) Provided written informed consent to participate, 2) Indicated a willingness to comply with study requirements for the specified follow-up duration, 3) Met all inclusion and exclusion criteria of this protocol.

Up to 60 subjects will be implanted at up to 5 sites in Germany.

Being tested
Inspire® Upper Airway Stimulation (UAS) System
Keywords
Obstructive Sleep Apnea, OSA, neurostimulation, hypoglossal nerve, tongue, upper airway stimulation, surgery
Medical subject headings
Sleep Apnea, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Inspire® Upper Airway Stimulation (UAS) SystemDevice

    Also called Inspire® Therapy

    This is a single-arm study; all participants will be implanted with the Inspire® Upper Airway Stimulation (UAS) System is a permanent, implantable therapy device, which consists of three implantable components: an IPG, a stimulation lead, and a sensing lead. In addition, the patient receives a remove to activate the therapy.

Study groups in NCT02293746
Study groupRoleWhat they receive
Inspire® UAS SystemOtherThis is a single-arm study; all participants will be implanted with the Inspire® Upper Airway Stimulation (UAS) System.
Receives: Device: Inspire® Upper Airway Stimulation (UAS) System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Reported SAEs / Procedure & Device Related AEs

    Safety of the therapy will be assessed via the description of all reported SAEs and all procedure- or device-related AEs. Adverse events will be summarized by seriousness, severity, relatedness to the device and/or procedure and temporal relationship to the procedure. No formal statistical hypotheses will be tested. Only device- or procedure-related AEs will be collected in this post-market study.

    Measured: 12 months post-implant

Secondary outcomes (1)

  1. Change from Baseline OSA at 12 Months

    Frequencies and description statistics will be used to describe the data gathered in this study. A statistical comparison of pre-implant baseline and follow-up data may be performed.

    Efficacy endpoints will evaluate changes in subjects' quality of life (QoL) and Obstructive Sleep Apnea (OSA) severity through:

    1. QoL: Epworth Sleepiness Scale: improvement from baseline to 12 months
    2. QoL: Functional Outcomes of Sleepiness Questionnaire: improvement from baseline to 12 months
    3. OSA Severity: Oxygen Desaturation Index: Reduction at 12 months as compared to baseline.
    4. OSA Severity: Apnea Hypopnea Index: Reduction at 12 months as compared to baseline.

    Measured: 12 months post-implant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2014 (estimated)
  2. Study startJun 2014
  3. Primary completion11 Dec 2016
  4. Study completion9 Jan 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Inspire Upper Airway Stimulation System
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02293746
Sponsor's protocol ID
2014-002
Status last verified
Jun 2020
First submitted
12 Nov 2014
Last updated
2 Jul 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes

Publications

  • Hofauer B, Philip P, Wirth M, Knopf A, Heiser C. Effects of upper-airway stimulation on sleep architecture in patients with obstructive sleep apnea. Sleep Breath. 2017 Dec;21(4):901-908. doi: 10.1007/s11325-017-1519-0. Epub 2017 May 31.

    PubMed 28567688

  • Heiser C, Edenharter G, Bas M, Wirth M, Hofauer B. Palatoglossus coupling in selective upper airway stimulation. Laryngoscope. 2017 Oct;127(10):E378-E383. doi: 10.1002/lary.26487. Epub 2017 Jan 20.

    PubMed 28105667

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Inspire® Upper Airway Stimulation (UAS) System in people with Obstructive Sleep Apnea, run by Inspire Medical Systems, Inc. at 3 sites in Germany.

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 4 inclusion and 14 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: finished, as of the sponsor's last update on 2 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Germany. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Reported SAEs / Procedure & Device Related AEs (time frame: 12 months post-implant). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02293746, which also lists 2 linked publications.

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 2 Jul 2020.

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