Targeted Hypoglossal Neurostimulation Study #3 (THN3)

February 6, 2024 updated by: ImThera Medical, Inc.

ImThera Medical Targeted Hypoglossal Neurostimulation Study #3

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The objectives of this study are to evaluate the safety and effectiveness of the aura6000 System for the treatment of moderate to severe obstructive sleep apnea (OSA) in individuals who have failed or do not tolerate positive airway pressure (PAP) therapy or have failed or are intolerant of or refuse indicated alternative OSA treatments (such as oral appliances, positional devices and conventional sleep surgeries). PAP failure is defined as an inability to eliminate OSA (AHI > 20 despite PAP usage) and PAP intolerance is defined as: 1) inability to use PAP (greater than 5 nights per week of usage; usage defined as greater than 4 hours of use per night); or 2) unwillingness to use PAP (for example, a patient returns the PAP system after attempting to use it). The results of this study are anticipated to provide reasonable assurance of the safety and effectiveness of the aura6000 System when used as intended and to support the application for FDA Premarket Approval of the system.

Study Type

Interventional

Enrollment (Actual)

138

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 Salpetriere
      • Suresnes, France
        • Foch Hospital
  • Germany
      • Mannheim, Germany
        • Ruprechts-Karls University
  • Israel
      • Haifa, Israel
        • Bnai Zion Medical Center
  • Portugal
      • Porto, Portugal
        • Hospital Cuf porto
  • United States
    • California
      • Chula Vista, California, United States, 91911
        • ENT Associates of San Diego
      • Los Angeles, California, United States, 90048
        • Tower ENT
      • San Diego, California, United States, 92108
        • Senta Clinic
    • Florida
      • Boca Raton, Florida, United States, 33487
        • Ear, Nose, and Throat Associates of South Florida
      • Safety Harbor, Florida, United States, 34695
        • Morton Plant Mease Healthcare
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Advanced ENT Asociates
    • Indiana
      • Carmel, Indiana, United States, 46032
        • Center for ENT and Allergy
    • Kentucky
      • Louisville, Kentucky, United States, 40218
        • Kentucky Research Group
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Johns Hopkins University
    • New York
      • New York, New York, United States, 10016
        • ENT and Allergy Associates
    • Ohio
      • Cincinnati, Ohio, United States, 45245
        • Intrepid Research
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Tennessee
      • Memphis, Tennessee, United States, 38104
        • UT Methodist Physicians
    • Texas
      • Austin, Texas, United States, 78731
        • FutureSearch Trials

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age >18 years
  • Individual has failed or does not tolerate PAP therapy
  • Has failed or refuses alternative OSA treatments (e.g.surgery, oral appliances, and behavioral treatments)
  • AHI ≥ 20 (Moderate to severe OSA)

Exclusion Critera:

  • Implanted with another active implantable device
  • Body mass index (BMI) ≥ 35 kg/m²

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
The Treatment Group will be implanted with the aura6000 System and have therapy turned ON at the Month 1 follow-up visit.
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).
Other Names:
  • THN Therapy
  • ImThera Medical
Other: Control
The Control Group will be implanted with the aura6000 System and receive treatment as-usual, (i.e. any non-PAP, non-surgical OSA treatment including oral appliances and positional devices being used prior to enrollment in the study) until 14 days (washout period) prior to the Month 4 visit. At the Month 4 + 1 day follow-up visit, subjects in the Control Group will have therapy turned ON for the duration of the study.
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).
Other Names:
  • THN Therapy
  • ImThera Medical

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in Apnea Hypopnea Index (AHI)
Time Frame: Baseline to 4 months post-implant

Proportion of subjects who experience improvement in the apnea-hypopnea index (AHI) at the Month 4 visit as defined above in the AHI Responder definition.

It is hypothesized that the observed responder rate in the Treatment Group will be significantly greater than the responder rate in the Control Group at 4 months post-implant.
Baseline to 4 months post-implant
Improvement in Oxygen Desaturation Index (ODI)
Time Frame: Baseline to 4 months post-implant

Proportion of subjects who experience improvement in the oxygen desaturation index 4% (ODI 4%) at the Month 4 visit as defined above in the ODI Responder definition.

It is hypothesized that the observed responder rate in the Treatment Group will be significantly greater than the responder rate in the Control Group at 4 months post-implant.
Baseline to 4 months post-implant
Safety Analysis
Time Frame: Baseline to 12 months post-implant
Estimate the incidence of serious adverse events (SAEs) related to the aura6000 device or procedure, including any unanticipated adverse device effects.
Baseline to 12 months post-implant

Secondary Outcome Measures

Outcome Measure
Time Frame
Long-term Responder Rate
Time Frame: Baseline to 12 months post-implant
Baseline to 12 months post-implant
Change in Epworth Sleepiness Scale (ESS)
Time Frame: Baseline to 4 months post-implant
Baseline to 4 months post-implant
Change in Functional Outcomes of Sleep (FOSQ)
Time Frame: Baseline to 4 months post-implant
Baseline to 4 months post-implant
Change in EuroQol 5 Dimensional (EQ-5D)
Time Frame: Baseline to 4 months post-implant
Baseline to 4 months post-implant

Collaborators and Investigators

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

Sponsor

ImThera Medical, Inc.

Collaborators

LivaNova

Investigators

  • Principal Investigator: Alan R Schwartz, MD, Professor (ret.), Johns Hopkins University

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 (Actual)

February 1, 2015

Primary Completion (Actual)

June 1, 2019

Study Completion (Actual)

September 1, 2023

Study Registration Dates

First Submitted

October 8, 2014

First Submitted That Met QC Criteria

October 10, 2014

First Posted (Estimated)

October 13, 2014

Study Record Updates

Last Update Posted (Estimated)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 6, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMT 2014-01

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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