- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01532180
Safety and Efficacy of a Hypoglossal Nerve Implant for the Treatment of Obstructive Sleep Apnea (OSA)
August 8, 2019 updated by: ImThera Medical, Inc.
A Pilot Study and Follow Up of the Use of a Hypoglossal Nerve Implant for Treatment of Obstructive Sleep Apnea
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Brussels, Belgium, 1200
- Clinique Univ. Saint-Luc
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: THN Therapy
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mean change in AHI measured through in-lab polysomnography (PSG) compared to baseline.
Time Frame: 3 and 12 months post-implant
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3 and 12 months post-implant
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Adverse events and Serious Adverse events peri and post-operatively
Time Frame: 3 and 12 months post-operative
|
3 and 12 months post-operative
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
3 and 12 months post-operative
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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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3 and 12 months post-implantation
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Daniel Rodenstein, MD, Clinique Univ. Saint-Luc
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2009
Primary Completion (Actual)
December 1, 2011
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
February 9, 2012
First Submitted That Met QC Criteria
February 9, 2012
First Posted (Estimate)
February 14, 2012
Study Record Updates
Last Update Posted (Actual)
August 12, 2019
Last Update Submitted That Met QC Criteria
August 8, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IMT 2009-01/02/03
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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