Clinical trial NCT02263859: Targeted Hypoglossal Neurostimulation Study #3
Official title: ImThera Medical Targeted Hypoglossal Neurostimulation Study #3
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: Obstructive Sleep Apnea
Lead sponsor: LivaNova
Sponsor class: INDUSTRY
Collaborators: name: LivaNova
First posted: 2014-10-13
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the benefits and risks of hypoglossal nerve stimulation with the ImThera Medical aura6000 System as a potential therapeutic option for individuals with moderate to severe OSA that have failed or do not tolerate PAP.

Detailed description: The objectives of this study are to evaluate the safety and effectiveness of the aura6000 System for the treatment of moderate to severe obstructive sleep apnea (OSA) in individuals who have failed or do not tolerate positive airway pressure (PAP) therapy or have failed or are intolerant of or refuse indicated alternative OSA treatments (such as oral appliances, positional devices and conventional sleep surgeries). PAP failure is defined as an inability to eliminate OSA (AHI \> 20 despite PAP usage) and PAP intolerance is defined as: 1) inability to use PAP (greater than 5 nights per week of usage; usage defined as greater than 4 hours of use per night); or 2) unwillingness to use PAP (for example, a patient returns the PAP system after attempting to use it). The results of this study are anticipated to provide reasonable assurance of the safety and effectiveness of the aura6000 System when used as intended and to support the application for FDA Premarket Approval of the system.

Eligibility criteria: Inclusion Criteria:

* Age \>18 years
* Individual has failed or does not tolerate PAP therapy
* Has failed or refuses alternative OSA treatments (e.g.surgery, oral appliances, and behavioral treatments)
* AHI ≥ 20 (Moderate to severe OSA)

Exclusion Critera:

* Implanted with another active implantable device
* Body mass index (BMI) ≥ 35 kg/m²

Primary outcomes:
measure: Improvement in Apnea Hypopnea Index (AHI)
timeFrame: Baseline to 4 months post-implant
measure: Improvement in Oxygen Desaturation Index (ODI)
timeFrame: Baseline to 4 months post-implant
measure: Safety Analysis
timeFrame: Baseline to 12 months post-implant
Secondary outcomes:
measure: Long-term Responder Rate
timeFrame: Baseline to 12 months post-implant
measure: Change in Epworth Sleepiness Scale (ESS)
timeFrame: Baseline to 4 months post-implant
measure: Change in Functional Outcomes of Sleep (FOSQ)
timeFrame: Baseline to 4 months post-implant
measure: Change in EuroQol 5 Dimensional (EQ-5D)
timeFrame: Baseline to 4 months post-implant
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: ENT Associates of San Diego
state: California
city: Los Angeles
country: United States
facility: Tower ENT
state: California
city: San Diego
country: United States
facility: SENTA Clinic
state: California
city: Boca Raton
country: United States
facility: Ear, Nose, and Throat Associates of South Florida
state: Florida
city: Safety Harbor
country: United States
facility: Morton Plant Mease Healthcare
state: Florida
city: Atlanta
country: United States
facility: Advanced ENT Asociates
state: Georgia
city: Carmel
country: United States
facility: Center for ENT and Allergy
state: Indiana
city: Louisville
country: United States
facility: Kentucky Research Group
state: Kentucky
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: New York
country: United States
facility: ENT and Allergy Associates
state: New York
city: Cincinnati
country: United States
facility: Intrepid Research
state: Ohio
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Memphis
country: United States
facility: UT Methodist Physicians
state: Tennessee
city: Austin
country: United States
facility: FutureSearch Trials
state: Texas
city: Brussels
country: Belgium
facility: Clinique Univ. Saint-Luc
city: Paris
country: France
facility: Pitie Salpetriere
city: Suresnes
country: France
facility: Foch Hospital
city: Mannheim
country: Germany
facility: Ruprechts-Karls University
city: Haifa
country: Israel
facility: Bnai Zion Medical Center
city: Porto
country: Portugal
facility: Hospital CUF Porto
Study officials:
affiliation: Professor (ret.), Johns Hopkins University
name: Alan R Schwartz, MD
role: PRINCIPAL_INVESTIGATOR
References: