Clinical trial NCT01796925: Targeted Hypoglossal Neurostimulation Study #2
Official title: Clinical Study of the aura6000™ Targeted Hypoglossal Implantable Neurostimulation (THN) Sleep Therapy System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Signs and Symptoms, Respiratory
Syndrome, Obstructive Sleep Apnea
Keywords: Apnea
Respiration Disorders
Signs and Symptoms
Signs and Symptoms, Respiratory
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Sleep Disorders
Nervous System Diseases
Lead sponsor: LivaNova
Sponsor class: INDUSTRY
First posted: 2013-02-22
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of the study is to confirm the safety and efficacy in patients utilizing the aura6000 System for the treatment of Obstructive Sleep Apnea (OSA).


Eligibility criteria: Inclusion Criteria:

* AHI \>20
* Noncompliant to CPAP
* Willing to provide informed consent
* Willing to comply with all follow-up visits and evaluations

Exclusion Criteria:

* BMI limits
* COPD
* Central Sleep Apnea
* Anatomic variations interfering with device placement or stability.

Primary outcomes:
measure: Reduction in Apnea-Hypopnea Index (AHI)
timeFrame: 3, 6, and 12 months post implant
measure: Reduction in Oxygen Desaturation Index (ODI)
timeFrame: 3, 6, and 12 months post implant
measure: Freedom from Serious Adverse Events (SAE)
timeFrame: 1 and 12 months post implant
Secondary outcomes:
measure: Improvement in sleep fragmentation
timeFrame: 3, 6, and 12 months post-implant
measure: Improvement in SAQLI
timeFrame: 3, 6, and 12 months post implant
measure: Improvement in ESS
timeFrame: 3, 6, and 12 months post implant
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Sharp Rees Stealy Medical Center
state: California
city: Denver
country: United States
facility: Porter Adventist Hospital
state: Colorado
city: Chicago
country: United States
facility: Chicago ENT
state: Illinois
city: Middletown
country: United States
facility: Orange Regional Medical Center
state: New York
city: Brussels
country: Belgium
facility: Clinique Univ. Saint-Luc
city: Paris
country: France
facility: Pitié-Salpêtrière Hospital
city: Berlin
country: Germany
facility: Advanced Sleep Research
city: Bremen
country: Germany
facility: St. Joseph-Stift
city: Forli
country: Italy
facility: G.B. Morgagni- L. Pierantoni Hospital
Study officials:
affiliation: Clinique Univ. Saint-Luc
name: Daniel Rodenstein, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hudson Valley ENT
name: Ofer Jacobowitz, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zaidi FN, Meadows P, Jacobowitz O, Davidson TM. Tongue anatomy and physiology, the scientific basis for a novel targeted neurostimulation system designed for the treatment of obstructive sleep apnea. Neuromodulation. 2013 Jul-Aug;16(4):376-86; discussion 386. doi: 10.1111/j.1525-1403.2012.00514.x. Epub 2012 Aug 31.
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.