Targeted Hypoglossal Neurostimulation Study #3

NCT02263859 | Completed

• 1 other identifier: IMT 2014-01
• Study Type: interventional
• Target: 138
• Locations: 6 countries
• Sites: 20

Brief 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

Obstructive Sleep Apnea

Keywords

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (3)

• 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.

  Baseline to 4 months post-implant

• 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.

  Baseline to 4 months post-implant

• Safety Analysis

  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 Outcomes (4)

• Long-term Responder Rate

  Baseline to 12 months post-implant

• Change in Epworth Sleepiness Scale (ESS)

  Baseline to 4 months post-implant

• Change in Functional Outcomes of Sleep (FOSQ)

  Baseline to 4 months post-implant

• Change in EuroQol 5 Dimensional (EQ-5D)

  Baseline to 4 months post-implant

Study Arms (2)

Treatment

EXPERIMENTAL

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

Control

OTHER

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

Interventions

aura6000 System DEVICE

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).

Also known as: THN Therapy, ImThera Medical

Control; Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• ImThera Medical, Inc.: lead
• LivaNova: collaborator

Study Sites (20)

ENT Associates of San Diego

Chula Vista, California, 91911, United States

Location

Tower ENT

Los Angeles, California, 90048, United States

Location

SENTA Clinic

San Diego, California, 92108, United States

Location

Ear, Nose, and Throat Associates of South Florida

Boca Raton, Florida, 33487, United States

Location

Morton Plant Mease Healthcare

Safety Harbor, Florida, 34695, United States

Location

Advanced ENT Asociates

Atlanta, Georgia, 30342, United States

Location

Center for ENT and Allergy

Carmel, Indiana, 46032, United States

Location

Kentucky Research Group

Louisville, Kentucky, 40218, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21224, United States

Location

ENT and Allergy Associates

New York, New York, 10016, United States

Location

Intrepid Research

Cincinnati, Ohio, 45245, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

UT Methodist Physicians

Memphis, Tennessee, 38104, United States

Location

FutureSearch Trials

Austin, Texas, 78731, United States

Location

Clinique Univ. Saint-Luc

Brussels, 1200, Belgium

Location

Pitie Salpetriere

Paris, 75013, France

Location

Foch Hospital

Suresnes, France

Location

Ruprechts-Karls University

Mannheim, Germany

Location

Bnai Zion Medical Center

Haifa, Israel

Location

Hospital CUF Porto

Porto, Portugal

Location

Related Publications (1)

• 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.

  PMID: 37022679 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Alan R Schwartz, MD

  Professor (ret.), Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2014
• First Posted: October 13, 2014
• Study Start: February 1, 2015
• Primary Completion: June 1, 2019
• Study Completion: September 1, 2023
• Last Updated: February 7, 2024

Record last verified: 2024-02

Locations

FR (2); DE (1); PT (1); BE (1); US (14); IL (1)