Inspire® Upper Airway Stimulation System

NCT02675816 | Terminated Phase 4

• 1 other identifier: 2015-001
• Study Type: interventional
• Target: 16
• Locations: 2 countries
• Sites: 4

Brief Summary

The purpose of this post-market study is to assess safety and effectiveness of Inspire Upper Airway System (UAS) in a commercial setting. This study will provide additional clinical evidence of Inspire UAS for treatment of moderate to severe obstructive sleep apnea (OSA) using a randomized controlled trial design.

Conditions

Obstructive Sleep Apnea

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change from Baseline OSA at 3 Months

  The percent of apnea hypopnea index (AHI) reduction will be used as a primary endpoint to quantify the effects of the Inspire therapy on OSA between the 'Active' therapy (ACTIVE) and 'Delayed Start' therapy (DELAY). The percent of AHI reduction is the percent change between baseline AHI at the pre-implant sleep study and AHI at the 3-month post-implant sleep study.

  3 months post-implant

Secondary Outcomes (4)

• Number of Reported SAEs / Procedure & Device Related AEs

  6 months post-implant

• Change from Baseline OSA at 6 Months

  6 months post-implant

• Change from Baseline Breathing Indices at 6 Months

  6 months post-implant

• Change from Baseline Quality of Life Questionnaires (QoL)

  6 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. This is a permanent, implantable therapy device, which consists of three implantable components: an implantable pulse generator (IPG), a stimulation lead, and a sensing lead. In addition, the patient receives a handheld remote 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:

• Meet the requirements per current CE Mark labeling
• Willing and capable to have stimulation hardware permanently implanted, and to use the patient remote 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:

• Do not meet any contraindications per current CE Mark labeling
• 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 (4)

Universitair Ziekenhuis Antwerpen

Antwerp, Belgium

Location

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

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

• Olivier Vanderveken, Prof. dr.

  University Hospital, Antwerp

  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

Study Record Dates

• First Submitted: January 28, 2016
• First Posted: February 5, 2016
• Study Start: August 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: August 11, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will share

Locations

BE (1); DE (3)