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OpenTrials
Completed

NCT Number: NCT01532180

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

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).

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Key information

Conditions

Sleep Apnea Syndromes Apnea Dyssomnias Nervous System Diseases Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders Syndrome, Obstructive Sleep Apnea

Age range

25 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique Univ. Saint-Luc

Brussels, 1200, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

aura6000 System

Device

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

ImThera Medical, Inc.

Industry

Registry information

Official study title

A Pilot Study and Follow Up of the Use of a Hypoglossal Nerve Implant for Treatment of Obstructive Sleep Apnea

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Feb 14, 2012
Registry last updated
Aug 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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