Safety and Efficacy of a Hypoglossal Nerve Implant for the Treatment of Obstructive Sleep Apnea (OSA)
A Pilot Study and Follow Up of the Use of a Hypoglossal Nerve Implant for Treatment of Obstructive Sleep Apnea
1 other identifier
interventional
14
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2009
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 9, 2012
CompletedFirst Posted
Study publicly available on registry
February 14, 2012
CompletedAugust 12, 2019
August 1, 2019
2.1 years
February 9, 2012
August 8, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Mean change in AHI measured through in-lab polysomnography (PSG) compared to baseline.
3 and 12 months post-implant
Adverse events and Serious Adverse events peri and post-operatively
3 and 12 months post-operative
Secondary Outcomes (2)
Mean change in Quality of Life outcomes measured with ESS (Epworth Sleepiness Scale) as compared to baseline.
3 and 12 months post-operative
Mean change in Quality of Life outcomes measured with FSS (Fatigue Severity Scale) as compared to baseline.
3 and 12 months post-implantation
Study Arms (1)
THN Therapy
EXPERIMENTALInterventions
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 Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinique Univ. Saint-Luc
Brussels, 1200, Belgium
Related Publications (1)
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.
PMID: 22599356DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel Rodenstein, MD
Clinique Univ. Saint-Luc
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2012
First Posted
February 14, 2012
Study Start
November 1, 2009
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
August 12, 2019
Record last verified: 2019-08