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Targeted Hypoglossal Neurostimulation Study #3

NCT02263859 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2024-02-07

No results posted yet for this study

Summary

The purpose of this study is to evaluate the benefits and risks of hypoglossal nerve stimulation with the ImThera Medical aura6000 System as a potential therapeutic option for individuals with moderate to severe OSA that have failed or do not tolerate PAP.

Conditions

Interventions

DEVICE

aura6000 System

The aura6000 System is intended to unilaterally stimulate the hypoglossal nerve which innervates the muscles of the tongue. The aura6000 System stimulates the hypoglossal nerve cyclically and continuously during sleep to maintain muscle tone of the tongue and upper airway during sleep. Stimulation is generated by a programmable, multi-current source, implantable neurostimulator (IPG) and delivered to the hypoglossal nerve by a lead with multi-contact cuff electrode (lead).

Sponsors & Collaborators

  • LivaNova

    collaborator INDUSTRY

  • ImThera Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Alan R Schwartz, MD · Professor (ret.), Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2019-06-30
Completion
2023-09-01

Countries

  • United States
  • Belgium
  • France
  • Germany
  • Israel
  • Portugal

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02263859 on ClinicalTrials.gov