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Safety and Efficacy of a Hypoglossal Nerve Implant for the Treatment of Obstructive Sleep Apnea (OSA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01532180
First Posted: February 14, 2012
Last Update Posted: February 14, 2012
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.
Information provided by (Responsible Party):
ImThera Medical, Inc.
  Purpose
The objective of the study is to determine the safety and preliminary 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 System Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study and Follow Up of the Use of a Hypoglossal Nerve Implant for Treatment of Obstructive Sleep Apnea

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Mean change in AHI measured through in-lab polysomnography (PSG) compared to baseline. [ Time Frame: 3 and 12 months post-implant ]
  • Adverse events and Serious Adverse events peri and post-operatively [ Time Frame: 3 and 12 months post-operative ]

Secondary Outcome Measures:
  • Mean change in Quality of Life outcomes measured with ESS (Epworth Sleepiness Scale) as compared to baseline. [ Time Frame: 3 and 12 months post-operative ]
  • Mean change in Quality of Life outcomes measured with FSS (Fatigue Severity Scale) as compared to baseline. [ Time Frame: 3 and 12 months post-implantation ]

Enrollment: 14
Study Start Date: November 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: THN Therapy Device: aura6000 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

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Moderate to severe obstructive sleep apnea (AHI 15 to 60).
  • Cannot or will not tolerate CPAP treatment.
  • Body mass index (BMI) between 25 and 40
  • Able to read, understand, sign and date the written informed consent form
  Contacts and Locations
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): NCT01532180


Locations
Belgium
Clinique Univ. Saint-Luc
Brussels, Belgium, 1200
Sponsors and Collaborators
ImThera Medical, Inc.
Investigators
Principal Investigator: Daniel Rodenstein, MD Clinique Univ. Saint-Luc
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: ImThera Medical, Inc.
ClinicalTrials.gov Identifier: NCT01532180     History of Changes
Other Study ID Numbers: IMT 2009-01/02/03
First Submitted: February 9, 2012
First Posted: February 14, 2012
Last Update Posted: February 14, 2012
Last Verified: February 2012

Keywords provided by ImThera Medical, Inc.:
Obstructive sleep apnea, neurostimulation, hypoglossal nerve

Additional relevant MeSH terms:
Sleep Apnea, Obstructive
Syndrome
Apnea
Sleep Apnea Syndromes
Signs and Symptoms
Respiration Disorders
Signs and Symptoms, Respiratory
Disease
Pathologic Processes
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases