Targeted Hypoglossal Neurostimulation Study #2 (THN2)
|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|
|Actual Primary Completion Date :||September 2013|
|Actual 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.
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|