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Targeted Hypoglossal Neurostimulation Study #2 (THN2)

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. Identifier: NCT01796925
Recruitment Status : Completed
First Posted : February 22, 2013
Last Update Posted : August 12, 2019
Information provided by (Responsible Party):
LivaNova ( ImThera Medical, Inc. )

Brief Summary:
The objective of the study is to confirm the safety and efficacy in patients utilizing the aura6000 System for the treatment of Obstructive Sleep Apnea (OSA).

Condition or disease Intervention/treatment Phase
Sleep Apnea Syndromes Sleep Apnea, Obstructive Respiration Disorders Signs and Symptoms, Respiratory Syndrome, Obstructive Sleep Apnea Device: aura6000 THN System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study of the aura6000™ Targeted Hypoglossal Implantable Neurostimulation (THN) Sleep Therapy System
Study Start Date : February 2013
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2014

Arm Intervention/treatment
Experimental: aura6000 THN Therapy
The aura6000 THN system will be implanted and activated for nightly therapy during sleep.
Device: aura6000 THN System
The aura6000 device is an implanted hypoglossal nerve stimulator designed to maintain wakeful muscle tone of the tongue during sleep. It is implanted through a short surgical procedure. The implant is programmed to provide the optimal stimulation parameters for the patient. The therapy is controlled by a hand-held remote control allowing the patient to start, stop, and pause the therapy during times of sleep.

Primary Outcome Measures :
  1. Reduction in Apnea-Hypopnea Index (AHI) [ Time Frame: 3, 6, and 12 months post implant ]
    Change from baseline in AHI measured through in-lab polysomnography (PSG).

  2. Reduction in Oxygen Desaturation Index (ODI) [ Time Frame: 3, 6, and 12 months post implant ]
    Change from baseline in ODI measured through in-lab polysomnography (PSG).

  3. Freedom from Serious Adverse Events (SAE) [ Time Frame: 1 and 12 months post implant ]
    Adverse events and Serious Adverse events post-operatively

Secondary Outcome Measures :
  1. Improvement in sleep fragmentation [ Time Frame: 3, 6, and 12 months post-implant ]
    Mean change in microarousal index as compared to baseline.

  2. Improvement in SAQLI [ Time Frame: 3, 6, and 12 months post implant ]
    Mean change in SAQLI (Sleep Apnea Quality of Life Index) as compared to baseline.

  3. Improvement in ESS [ Time Frame: 3, 6, and 12 months post implant ]
    Mean change in ESS (Epworth Sleepiness Scale) as compared to baseline.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Inclusion Criteria:

  • AHI >20
  • Noncompliant to CPAP
  • Willing to provide informed consent
  • Willing to comply with all follow-up visits and evaluations

Exclusion Criteria:

  • BMI limits
  • COPD
  • Central Sleep Apnea
  • Anatomic variations interfering with device placement or stability.

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 identifier (NCT number): NCT01796925

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United States, California
Sharp Rees Stealy Medical Center
San Diego, California, United States, 92123
United States, Colorado
Porter Adventist Hospital
Denver, Colorado, United States, 80210
United States, Illinois
Chicago ENT
Chicago, Illinois, United States, 60657
United States, New York
Orange Regional Medical Center
Middletown, New York, United States, 10940
Clinique Univ. Saint-Luc
Brussels, Belgium, 1200
Pitié-Salpêtrière Hospital
Paris, France, 75013
Advanced Sleep Research
Berlin, Germany, 10117
St. Joseph-Stift
Bremen, Germany, 28209
G.B. Morgagni- L. Pierantoni Hospital
Forli, Italy, 47121
Sponsors and Collaborators
ImThera Medical, Inc.
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Principal Investigator: Daniel Rodenstein, MD, PhD Clinique Univ. Saint-Luc
Principal Investigator: Ofer Jacobowitz, MD PhD Hudson Valley ENT

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Responsible Party: ImThera Medical, Inc. Identifier: NCT01796925    
Other Study ID Numbers: IMT2012-02
First Posted: February 22, 2013    Key Record Dates
Last Update Posted: August 12, 2019
Last Verified: August 2019
Keywords provided by LivaNova ( ImThera Medical, Inc. ):
Respiration Disorders
Signs and Symptoms
Signs and Symptoms, Respiratory
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Sleep Disorders
Nervous System Diseases
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Signs and Symptoms, Respiratory
Signs and Symptoms
Pathologic Processes
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases