Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ImThera Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01532180
First received: February 9, 2012
Last updated: NA
Last verified: February 2012
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]
  • Adverse events and Serious Adverse events peri and post-operatively [ Time Frame: 3 and 12 months post-operative ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   25 Years to 70 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by ImThera Medical, Inc.

Additional 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
Study First Received: February 9, 2012
Last Updated: February 9, 2012
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Belgium: Ethics Committee

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

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

ClinicalTrials.gov processed this record on November 24, 2014