Targeted Hypoglossal Neurostimulation Study #2 (THN2)

August 8, 2019 updated by: ImThera Medical, Inc.

Clinical Study of the aura6000™ Targeted Hypoglossal Implantable Neurostimulation (THN) Sleep Therapy System

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1200
        • Clinique Univ. Saint-Luc
  • France
      • Paris, France, 75013
        • Pitie-Salpêtrière Hospital
  • Germany
      • Berlin, Germany, 10117
        • Advanced Sleep Research
      • Bremen, Germany, 28209
        • St. Joseph-Stift
  • Italy
      • Forli, Italy, 47121
        • G.B. Morgagni- L. Pierantoni Hospital
  • United States
    • California
      • San Diego, California, United States, 92123
        • Sharp Rees Stealy Medical Center
    • Colorado
      • Denver, Colorado, United States, 80210
        • Porter Adventist Hospital
    • Illinois
      • Chicago, Illinois, United States, 60657
        • Chicago ENT
    • New York
      • Middletown, New York, United States, 10940
        • Orange Regional Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • AHI >20
  • Noncompliant to CPAP
  • Willing to provide informed consent
  • Willing to comply with all follow-up visits and evaluations

Exclusion Criteria:

  • BMI limits
  • COPD
  • Central Sleep Apnea
  • Anatomic variations interfering with device placement or stability.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: aura6000 THN Therapy
The aura6000 THN system will be implanted and activated for nightly therapy during sleep.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in Apnea-Hypopnea Index (AHI)
Time Frame: 3, 6, and 12 months post implant
Change from baseline in AHI measured through in-lab polysomnography (PSG).
3, 6, and 12 months post implant
Reduction in Oxygen Desaturation Index (ODI)
Time Frame: 3, 6, and 12 months post implant
Change from baseline in ODI measured through in-lab polysomnography (PSG).
3, 6, and 12 months post implant
Freedom from Serious Adverse Events (SAE)
Time Frame: 1 and 12 months post implant
Adverse events and Serious Adverse events post-operatively
1 and 12 months post implant

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in sleep fragmentation
Time Frame: 3, 6, and 12 months post-implant
Mean change in microarousal index as compared to baseline.
3, 6, and 12 months post-implant
Improvement in SAQLI
Time Frame: 3, 6, and 12 months post implant
Mean change in SAQLI (Sleep Apnea Quality of Life Index) as compared to baseline.
3, 6, and 12 months post implant
Improvement in ESS
Time Frame: 3, 6, and 12 months post implant
Mean change in ESS (Epworth Sleepiness Scale) as compared to baseline.
3, 6, and 12 months post implant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ImThera Medical, Inc.

Investigators

  • Principal Investigator: Daniel Rodenstein, MD, PhD, Clinique Univ. Saint-Luc
  • Principal Investigator: Ofer Jacobowitz, MD PhD, Hudson Valley ENT

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (ACTUAL)

September 1, 2013

Study Completion (ACTUAL)

September 1, 2014

Study Registration Dates

First Submitted

February 14, 2013

First Submitted That Met QC Criteria

February 20, 2013

First Posted (ESTIMATE)

February 22, 2013

Study Record Updates

Last Update Posted (ACTUAL)

August 12, 2019

Last Update Submitted That Met QC Criteria

August 8, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMT2012-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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