Back to resultsSafety and Efficacy of a Hypoglossal Nerve Implant for the Treatment of Obstructive Sleep Apnea (OSA)
Primary Purpose
Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Respiration Disorders
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
aura6000 System
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Apnea Syndromes focused on measuring Obstructive sleep apnea, neurostimulation, hypoglossal nerve
Eligibility 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
Sites / Locations
- Clinique Univ. Saint-Luc
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
THN Therapy
Arm Description
Outcomes
Primary Outcome Measures
Mean change in AHI measured through in-lab polysomnography (PSG) compared to baseline.
Adverse events and Serious Adverse events peri and post-operatively
Secondary Outcome Measures
Mean change in Quality of Life outcomes measured with ESS (Epworth Sleepiness Scale) as compared to baseline.
Mean change in Quality of Life outcomes measured with FSS (Fatigue Severity Scale) as compared to baseline.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01532180
Brief Title
Safety and Efficacy of a Hypoglossal Nerve Implant for the Treatment of Obstructive Sleep Apnea (OSA)
Official Title
A Pilot Study and Follow Up of the Use of a Hypoglossal Nerve Implant for Treatment of Obstructive Sleep Apnea
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ImThera Medical, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Respiration Disorders, Signs and Symptoms, Respiratory, Syndrome, Obstructive Sleep Apnea
Keywords
Obstructive sleep apnea, neurostimulation, hypoglossal nerve
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
THN Therapy
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
aura6000 System
Intervention Description
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 Measure Information:
Title
Mean change in AHI measured through in-lab polysomnography (PSG) compared to baseline.
Time Frame
3 and 12 months post-implant
Title
Adverse events and Serious Adverse events peri and post-operatively
Time Frame
3 and 12 months post-operative
Secondary Outcome Measure Information:
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Rodenstein, MD
Organizational Affiliation
Clinique Univ. Saint-Luc
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinique Univ. Saint-Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
12. IPD Sharing Statement
Citations:
PubMed Identifier
22599356
Citation
Mwenge GB, Rombaux P, Dury M, Lengele B, Rodenstein D. Targeted hypoglossal neurostimulation for obstructive sleep apnoea: a 1-year pilot study. Eur Respir J. 2013 Feb;41(2):360-7. doi: 10.1183/09031936.00042412. Epub 2012 May 17.
Results Reference
derived
Learn more about this trial
Safety and Efficacy of a Hypoglossal Nerve Implant for the Treatment of Obstructive Sleep Apnea (OSA)
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