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Targeted Hypoglossal Neurostimulation Study #2 (THN2)

This study is currently recruiting participants.
Verified February 2013 by ImThera Medical, Inc.
Sponsor:
Information provided by (Responsible Party):
ImThera Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01796925
First received: February 14, 2013
Last updated: February 20, 2013
Last verified: February 2013
History of Changes
  Purpose

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 Intervention Phase
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Signs and Symptoms, Respiratory
Syndrome, Obstructive Sleep Apnea
 Device: aura6000 THN System
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Study of the aura6000™ Targeted Hypoglossal Implantable Neurostimulation (THN) Sleep Therapy System

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by ImThera Medical, Inc.:

Primary Outcome Measures:
  • Reduction in Apnea-Hypopnea Index (AHI) [ Time Frame: 3, 6, and 12 months post implant ] [ Designated as safety issue: No ]
    Change from baseline in AHI measured through in-lab polysomnography (PSG).

  • Reduction in Oxygen Desaturation Index (ODI) [ Time Frame: 3, 6, and 12 months post implant ] [ Designated as safety issue: No ]
    Change from baseline in ODI measured through in-lab polysomnography (PSG).

  • Freedom from Serious Adverse Events (SAE) [ Time Frame: 1 and 12 months post implant ] [ Designated as safety issue: Yes ]
    Adverse events and Serious Adverse events post-operatively


Secondary Outcome Measures:
  • Improvement in sleep fragmentation [ Time Frame: 3, 6, and 12 months post-implant ] [ Designated as safety issue: No ]
    Mean change in microarousal index as compared to baseline.

  • Improvement in SAQLI [ Time Frame: 3, 6, and 12 months post implant ] [ Designated as safety issue: No ]
    Mean change in SAQLI (Sleep Apnea Quality of Life Index) as compared to baseline.

  • Improvement in ESS [ Time Frame: 3, 6, and 12 months post implant ] [ Designated as safety issue: No ]
    Mean change in ESS (Epworth Sleepiness Scale) as compared to baseline.


Estimated Enrollment: 60
Study Start Date: February 2013
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01796925

Locations
Belgium
Clinique Univ. Saint-Luc Recruiting
Brussels, Belgium, 1200
Contact: Daniel Rodenstein, MD, PhD         daniel.rodenstein@uclouvain.be    
Principal Investigator: Daniel Rodenstein, MD, PhD            
Germany
St. Joseph-Stift Recruiting
Bremen, Germany, 28209
Contact: Wolfgang Bergler, MD PhD         wbergler@sjs-bremen.de    
Sponsors and Collaborators
ImThera Medical, Inc.
Investigators
Principal Investigator: Daniel Rodenstein, MD, PhD Clinique Univ. Saint-Luc
Principal Investigator: Wolfgang Bergler, MD PhD St. Joseph-Stift Bremen
  More Information

Publications:

Responsible Party: ImThera Medical, Inc.
ClinicalTrials.gov Identifier: NCT01796925     History of Changes
Other Study ID Numbers: IMT2012-02
Study First Received: February 14, 2013
Last Updated: February 20, 2013
Health Authority: United States: Food and Drug Administration
Belgium: Ethics Committee
Germany: Ethics Commission

Keywords provided by ImThera Medical, Inc.:
Apnea
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:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Respiration Disorders
Signs and Symptoms
Signs and Symptoms, Respiratory
 Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on June 18, 2013