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Targeted Hypoglossal Neurostimulation Study #2

NCT01796925 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2019-08-12

No results posted yet for this study

Summary

The objective of the study is to confirm the safety and efficacy in patients utilizing the aura6000 System for the treatment of Obstructive Sleep Apnea (OSA).

Conditions

  • Sleep Apnea Syndromes
  • Sleep Apnea, Obstructive
  • Respiration Disorders
  • Signs and Symptoms, Respiratory
  • Syndrome, Obstructive Sleep Apnea

Interventions

DEVICE

aura6000 THN System

The aura6000 device is an implanted hypoglossal nerve stimulator designed to maintain wakeful muscle tone of the tongue during sleep. It is implanted through a short surgical procedure. The implant is programmed to provide the optimal stimulation parameters for the patient. The therapy is controlled by a hand-held remote control allowing the patient to start, stop, and pause the therapy during times of sleep.

Sponsors & Collaborators

  • ImThera Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Daniel Rodenstein, MD, PhD · Clinique Univ. Saint-Luc

  • Ofer Jacobowitz, MD PhD · Hudson Valley ENT

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2013-09-30
Completion
2014-09-30

Countries

  • United States
  • Belgium
  • France
  • Germany
  • Italy

Study Locations

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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 NCT01796925 on ClinicalTrials.gov