Targeted Hypoglossal Neurostimulation Study #2 (THN2)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01796925|
Recruitment Status : Completed
First Posted : February 22, 2013
Last Update Posted : October 7, 2014
|Condition or disease||Intervention/treatment||Phase|
|Sleep Apnea Syndromes Sleep Apnea, Obstructive Respiration Disorders Signs and Symptoms, Respiratory Syndrome, Obstructive Sleep Apnea||Device: aura6000 THN System||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||57 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Study of the aura6000™ Targeted Hypoglossal Implantable Neurostimulation (THN) Sleep Therapy System|
|Study Start Date :||February 2013|
|Primary Completion Date :||September 2013|
|Study Completion Date :||September 2014|
Experimental: aura6000 THN Therapy
The aura6000 THN system will be implanted and activated for nightly therapy during sleep.
Device: aura6000 THN 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.
- Reduction in Apnea-Hypopnea Index (AHI) [ Time Frame: 3, 6, and 12 months post implant ]Change from baseline in AHI measured through in-lab polysomnography (PSG).
- Reduction in Oxygen Desaturation Index (ODI) [ Time Frame: 3, 6, and 12 months post implant ]Change from baseline in ODI measured through in-lab polysomnography (PSG).
- Freedom from Serious Adverse Events (SAE) [ Time Frame: 1 and 12 months post implant ]Adverse events and Serious Adverse events post-operatively
- Improvement in sleep fragmentation [ Time Frame: 3, 6, and 12 months post-implant ]Mean change in microarousal index as compared to baseline.
- Improvement in SAQLI [ Time Frame: 3, 6, and 12 months post implant ]Mean change in SAQLI (Sleep Apnea Quality of Life Index) as compared to baseline.
- Improvement in ESS [ Time Frame: 3, 6, and 12 months post implant ]Mean change in ESS (Epworth Sleepiness Scale) as compared to baseline.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01796925
|United States, California|
|Sharp Rees Stealy Medical Center|
|San Diego, California, United States, 92123|
|United States, Colorado|
|Porter Adventist Hospital|
|Denver, Colorado, United States, 80210|
|United States, Illinois|
|Chicago, Illinois, United States, 60657|
|United States, New York|
|Orange Regional Medical Center|
|Middletown, New York, United States, 10940|
|Clinique Univ. Saint-Luc|
|Brussels, Belgium, 1200|
|Paris, France, 75013|
|Advanced Sleep Research|
|Berlin, Germany, 10117|
|Bremen, Germany, 28209|
|G.B. Morgagni- L. Pierantoni Hospital|
|Forli, Italy, 47121|
|Principal Investigator:||Daniel Rodenstein, MD, PhD||Clinique Univ. Saint-Luc|
|Principal Investigator:||Ofer Jacobowitz, MD PhD||Hudson Valley ENT|