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Completed

NCT Number: NCT02263859

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique Univ. Saint-Luc, Brussels, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Other names: THN Therapy, ImThera Medical

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Long-term Responder Rate

    Time frame: Baseline to 12 months post-implant

  2. Change in Epworth Sleepiness Scale (ESS)

    Time frame: Baseline to 4 months post-implant

  3. Change in Functional Outcomes of Sleep (FOSQ)

    Time frame: Baseline to 4 months post-implant

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

    Time frame: Baseline to 4 months post-implant

Sponsors and collaborators

Lead sponsor

ImThera Medical, Inc.

Industry

Collaborators

  • LivaNova

Registry information

Official study title

ImThera Medical Targeted Hypoglossal Neurostimulation Study #3

Acronym: THN3

Important dates

Study start
2015
Primary completion
2019
Study completion
2023
First posted
Oct 13, 2014
Registry last updated
Feb 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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