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

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ClinicalTrials.gov Identifier: NCT01532180
Recruitment Status : Completed
First Posted : February 14, 2012
Last Update Posted : February 14, 2012
Sponsor:
Information provided by (Responsible Party):
ImThera Medical, Inc.

Brief Summary:
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 or disease Intervention/treatment 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  (Clinical Trial)
Actual Enrollment : 14 participants
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
Study Start Date : November 2009
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Arm Intervention/treatment
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.



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

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]


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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

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

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 Posted: February 14, 2012    Key Record Dates
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:
Syndrome
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
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