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

June 30, 2020 updated by: Inspire Medical Systems, Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Lübeck, Germany, 23538
        • Klinik für HNO-Heilkunde/HNO-Schlaflabor
      • Mannheim, Germany, D-68135
        • Universitäts-HNO-Klinik Mannheim
      • München, Germany, D-81675
        • Klinikum Rechts Der Isar Der Technischen Universität München

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 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
  2. Willing and capable to have stimulation hardware permanently implanted, and to use the patient programmer to activate the stimulation
  3. Willing and capable to return for all follow-up visits and conduct sleep studies at home, including the evaluation procedures and filling out questionnaires
  4. Willing and capable of providing informed consent

Exclusion Criteria:

Contraindications

  1. Any anatomical finding that would compromise the performance of upper airway stimulation, such as the presence of complete concentric collapse of the soft palate
  2. Have any condition or procedure that has compromised neurological control of the upper airway
  3. Unable or do not have the necessary assistance to operate the patient programmer
  4. Pregnant or plan to become pregnant
  5. Require magnetic resonance imaging (MRI)

  6. Have an implantable device that may be susceptible to unintended interaction with the Inspire system.

    Additional exclusions for study purposes only:

  7. Body Mass Index (BMI) of > 35
  8. Central + mixed apneas > 25% of the total apnea-hypopnea index (AHI)
  9. Any chronic medical illness or condition that contraindicates a surgical procedure under general anesthesia, as judged by the clinical study Investigator
  10. Has a terminal illness with life expectancy < 12 months
  11. Active psychiatric disease (psychotic illness, major depression, or acute anxiety attacks) which prevents subject compliance with the requirements of the investigational study testing
  12. Any other reason the investigator deems subject is unfit for participation in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Inspire® UAS System
This is a single-arm study; all participants will be implanted with the Inspire® Upper Airway Stimulation (UAS) System.
Device: Inspire® Upper Airway Stimulation (UAS) System
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.
Other Names:
  • Inspire® Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Reported SAEs / Procedure & Device Related AEs
Time Frame: 12 months post-implant
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.
12 months post-implant

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline OSA at 12 Months
Time Frame: 12 months post-implant

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.
12 months post-implant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inspire Medical Systems, Inc.

Investigators

  • Principal Investigator: Clemens Heiser, Dr. med., Klinikum Rechts Der Isar Der Technischen Universität München
  • Principal Investigator: Joachim T. Maurer, OA Dr. med., Universitäts-HNO-Klinik Mannheim
  • Principal Investigator: Armin Steffen, PD Dr. med., Klinik für HNO-Heilkunde/HNO-Schlaflabor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2014

Primary Completion (Actual)

December 11, 2016

Study Completion (Actual)

January 9, 2017

Study Registration Dates

First Submitted

November 12, 2014

First Submitted That Met QC Criteria

November 14, 2014

First Posted (Estimate)

November 18, 2014

Study Record Updates

Last Update Posted (Actual)

July 2, 2020

Last Update Submitted That Met QC Criteria

June 30, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-002 (Other Identifier: Barbara Ann Karmanos Cancer Institute)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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