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

Primary Purpose

Obstructive Sleep Apnea

Status

Completed

Phase

Phase 4

Locations

Germany

Study Type

Interventional

Intervention

Inspire® Upper Airway Stimulation (UAS) System

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring Obstructive Sleep Apnea, OSA, neurostimulation, hypoglossal nerve, tongue, upper airway stimulation, surgery

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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)
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

Sites / Locations

Klinik für HNO-Heilkunde/HNO-Schlaflabor
Universitäts-HNO-Klinik Mannheim
Klinikum rechts der Isar der Technischen Universität München

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Inspire® UAS System

Arm Description

This is a single-arm study; all participants will be implanted with the Inspire® Upper Airway Stimulation (UAS) System.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

NCT ID

NCT02293746

First Posted

November 12, 2014

Last Updated

June 30, 2020

Sponsor

Inspire Medical Systems, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02293746

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Completed

Study Start Date

June 2014 (Actual)

Primary Completion Date

December 11, 2016 (Actual)

Study Completion Date

January 9, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Inspire Medical Systems, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obstructive Sleep Apnea

Keywords

Obstructive Sleep Apnea, OSA, neurostimulation, hypoglossal nerve, tongue, upper airway stimulation, surgery

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Model Description

Inspire Upper Airway Stimulation System

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Inspire® UAS System

Arm Type

Other

Arm Description

This is a single-arm study; all participants will be implanted with the Inspire® Upper Airway Stimulation (UAS) System.

Intervention Type

Device

Intervention Name(s)

Inspire® Upper Airway Stimulation (UAS) System

Other Intervention Name(s)

Inspire® Therapy

Intervention Description

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.

Primary Outcome Measure Information:

Title

Number of Reported SAEs / Procedure & Device Related AEs

Description

Time Frame

12 months post-implant

Secondary Outcome Measure Information:

Title

Change from Baseline OSA at 12 Months

Description

Time Frame

12 months post-implant

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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) 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clemens Heiser, Dr. med.

Organizational Affiliation

Klinikum rechts der Isar der Technischen Universität München

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Joachim T. Maurer, OA Dr. med.

Organizational Affiliation

Universitäts-HNO-Klinik Mannheim

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Armin Steffen, PD Dr. med.

Organizational Affiliation

Klinik für HNO-Heilkunde/HNO-Schlaflabor

Official's Role

Principal Investigator

Facility Information:

Facility Name

Klinik für HNO-Heilkunde/HNO-Schlaflabor

City

Lübeck

ZIP/Postal Code

23538

Country

Germany

Facility Name

Universitäts-HNO-Klinik Mannheim

City

Mannheim

ZIP/Postal Code

D-68135

Country

Germany

Facility Name

Klinikum rechts der Isar der Technischen Universität München

City

München

ZIP/Postal Code

D-81675

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Yes

Citations:

PubMed Identifier

28567688

Citation

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.

Results Reference

derived

PubMed Identifier

28105667

Citation

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.

Results Reference

derived

Links:

URL

https://pubmed.ncbi.nlm.nih.gov/28561345/

Description

Peer-reviewed publication/results (Laryngoscope 2018)

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

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