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Targeted Hypoglossal Neurostimulation Study #3 (THN3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02263859
Recruitment Status : Active, not recruiting
First Posted : October 13, 2014
Last Update Posted : August 12, 2019
Sponsor:
Information provided by (Responsible Party):
LivaNova ( ImThera Medical, Inc. )

Study Description
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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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Device: aura6000 System Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 138 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ImThera Medical Targeted Hypoglossal Neurostimulation Study #3
Actual Study Start Date : February 2015
Actual Primary Completion Date : June 2019
Estimated Study Completion Date : December 2022

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Arms and Interventions
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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
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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02263859


Locations
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Sponsors and Collaborators
ImThera Medical, Inc.
Investigators
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Principal Investigator: Alan R Schwartz, MD Johns Hopkins University
More Information
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Responsible Party: ImThera Medical, Inc.
ClinicalTrials.gov Identifier: NCT02263859    
Other Study ID Numbers: IMT 2014-01
First Posted: October 13, 2014    Key Record Dates
Last Update Posted: August 12, 2019
Last Verified: August 2019
Keywords provided by LivaNova ( ImThera Medical, Inc. ):
Obstructive Sleep Apnea
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Respiration Disorders
Respiratory Tract Diseases
 Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases