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Obstructive Sleep ApneaTHN3NCT02263859

Targeted Hypoglossal Neurostimulation Study #3

A study testing aura6000 System in people with Obstructive Sleep Apnea, run by ImThera Medical, Inc. at 20 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obstructive Sleep Apnea
What is being tested?
aura6000 System
Could I receive a placebo?
No, everyone receives an active treatment
How many people
138 participants
Where
20 sitesin 6 countries
Study dates
Feb 2015to 1 Sep 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

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

Trial locations and contacts

20 sites in 6 countries.

20 sites in 6 countries

United States14 sites

  • Advanced ENT Asociates

    Atlanta, Georgia, 30342

  • FutureSearch Trials

    Austin, Texas, 78731

  • Johns Hopkins University

    Baltimore, Maryland, 21224

  • Ear, Nose, and Throat Associates of South Florida

    Boca Raton, Florida, 33487

  • Center for ENT and Allergy

    Carmel, Indiana, 46032

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • ENT Associates of San Diego

    Chula Vista, California, 91911

  • Intrepid Research

    Cincinnati, Ohio, 45245

  • Tower ENT

    Los Angeles, California, 90048

  • Kentucky Research Group

    Louisville, Kentucky, 40218

  • UT Methodist Physicians

    Memphis, Tennessee, 38104

  • ENT and Allergy Associates

    New York, New York, 10016

  • Morton Plant Mease Healthcare

    Safety Harbor, Florida, 34695

  • SENTA Clinic

    San Diego, California, 92108

Other trials in United States

France2 sites

  • Pitie Salpetriere

    Paris, 75013

  • Foch Hospital

    Suresnes

Other trials in France

Belgium1 site

  • Clinique Univ. Saint-Luc

    Brussels, 1200

Other trials in Belgium

Germany1 site

  • Ruprechts-Karls University

    Mannheim

Other trials in Germany

Israel1 site

  • Bnai Zion Medical Center

    Haifa

Other trials in Israel

Portugal1 site

  • Hospital CUF Porto

    Porto

Other trials in Portugal

About this study

Official title: 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.

Read the 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.

Being tested
aura6000 System
Keywords
Obstructive Sleep Apnea
Medical subject headings
Sleep Apnea, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • aura6000 SystemDevice

    Also called THN Therapy, ImThera Medical

    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).

Study groups in NCT02263859
Study groupRoleWhat they receive
TreatmentExperimentalThe Treatment Group will be implanted with the aura6000 System and have therapy turned ON at the Month 1 follow-up visit.
Receives: Device: aura6000 System
ControlOtherThe 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.
Receives: Device: aura6000 System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Improvement in Apnea Hypopnea Index (AHI)

    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.

    Measured: Baseline to 4 months post-implant

  2. Improvement in Oxygen Desaturation Index (ODI)

    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.

    Measured: Baseline to 4 months post-implant

  3. Safety Analysis

    Estimate the incidence of serious adverse events (SAEs) related to the aura6000 device or procedure, including any unanticipated adverse device effects.

    Measured: Baseline to 12 months post-implant

Secondary outcomes (4)

  1. Long-term Responder Rate

    Measured: Baseline to 12 months post-implant

  2. Change in Epworth Sleepiness Scale (ESS)

    Measured: Baseline to 4 months post-implant

  3. Change in Functional Outcomes of Sleep (FOSQ)

    Measured: Baseline to 4 months post-implant

  4. Change in EuroQol 5 Dimensional (EQ-5D)

    Measured: Baseline to 4 months post-implant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2014 (estimated)
  2. Study startFeb 2015
  3. Primary completionJun 2019
  4. Study completion1 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
138 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02263859
Sponsor's protocol ID
IMT 2014-01
Acronym
THN3
Status last verified
Feb 2024
First submitted
8 Oct 2014
Last updated
7 Feb 2024
Results posted
No
Data monitoring committee
No

Publications

  • Schwartz AR, Jacobowitz O, Mickelson SA, Miller MB, Oliven A, Certal V, Hopp ML, Winslow DH, Huntley TC, Nachlas NE, Pham LV, Eisele DW, Gillespie MB, Weeks BH, Lovett EG, Shen J, Malhotra A, Maurer JT. Three-Year Outcomes of Proximal Hypoglossal Nerve Stimulation in OSA. Chest. 2026 May;169(5):1357-1370. doi: 10.1016/j.chest.2025.11.057. Epub 2026 Feb 12.

    PubMed 41690459

  • Schwartz AR, Jacobowitz O, Eisele DW, Mickelson SA, Miller MB, Oliven A, Certal V, Hopp ML, Winslow DH, Huntley TC, Nachlas NE, Pham LV, Gillespie MB, Weeks BH, Lovett EG, Shen J, Malhotra A, Maurer JT. Targeted Hypoglossal Nerve Stimulation for Patients With Obstructive Sleep Apnea: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2023 Jun 1;149(6):512-520. doi: 10.1001/jamaoto.2023.0161.

    PubMed 37022679

Questions about this trial

What is this clinical trial studying?

A study testing aura6000 System in people with Obstructive Sleep Apnea, run by ImThera Medical, Inc. at 20 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States, France, Belgium, Germany, Israel and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Improvement in Apnea Hypopnea Index (AHI) (time frame: Baseline to 4 months post-implant). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02263859, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024; AzTrials last refreshed its copy on 29 Oct 2026.

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