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

NCT02293746 | Completed Phase 4

• 1 other identifier: 2014-002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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.

Conditions

Obstructive Sleep Apnea

Keywords

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

Outcome Measures

Primary Outcomes (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.

  12 months post-implant

Secondary Outcomes (1)

• Change from Baseline OSA at 12 Months

  12 months post-implant

Study Arms (1)

Inspire® UAS System

OTHER

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

Interventions

Inspire® Upper Airway Stimulation (UAS) System DEVICE

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.

Also known as: Inspire® Therapy

Inspire® UAS System

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Inspire Medical Systems, Inc.: lead

Study Sites (3)

Klinik für HNO-Heilkunde/HNO-Schlaflabor

Lübeck, 23538, Germany

Location

Universitäts-HNO-Klinik Mannheim

Mannheim, D-68135, Germany

Location

Klinikum rechts der Isar der Technischen Universität München

München, D-81675, Germany

Location

Related Publications (2)

• 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.

  PMID: 28567688 DERIVED

• 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.

  PMID: 28105667 DERIVED

Related Links

• Peer-reviewed publication/results (Laryngoscope 2018)

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Inspire Upper Airway Stimulation System

Study Record Dates

• First Submitted: November 12, 2014
• First Posted: November 18, 2014
• Study Start: June 1, 2014
• Primary Completion: December 11, 2016
• Study Completion: January 9, 2017
• Last Updated: July 2, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will share

Locations

DE (3)