Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
138 participants
INTERVENTIONAL
2015-02-28
2023-09-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Targeted Hypoglossal Neurostimulation Study #2
NCT01796925
Treating Obstructive Sleep Apnea Using Targeted Hypoglossal Neurostimulation
NCT04950894
Safety and Efficacy of a Hypoglossal Nerve Implant for the Treatment of Obstructive Sleep Apnea (OSA)
NCT01532180
Effect of Upper Airway Stimulation on Vascular Function in Obstructive Sleep Apnea
NCT03051165
Stimulation Therapy for Apnea Reduction (Www.theSTARtrial.Com)
NCT01161420
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treatment
The Treatment Group will be implanted with the aura6000 System and have therapy turned ON at the Month 1 follow-up visit.
aura6000 System
The aura6000 System is intended to unilaterally stimulate the hypoglossal nerve which innervates the muscles of the tongue. The aura6000 System stimulates the hypoglossal nerve cyclically and continuously during sleep to maintain muscle tone of the tongue and upper airway during sleep. Stimulation is generated by a programmable, multi-current source, implantable neurostimulator (IPG) and delivered to the hypoglossal nerve by a lead with multi-contact cuff electrode (lead).
Control
The Control Group will be implanted with the aura6000 System and receive treatment as-usual, (i.e. any non-PAP, non-surgical OSA treatment including oral appliances and positional devices being used prior to enrollment in the study) until 14 days (washout period) prior to the Month 4 visit. At the Month 4 + 1 day follow-up visit, subjects in the Control Group will have therapy turned ON for the duration of the study.
aura6000 System
The aura6000 System is intended to unilaterally stimulate the hypoglossal nerve which innervates the muscles of the tongue. The aura6000 System stimulates the hypoglossal nerve cyclically and continuously during sleep to maintain muscle tone of the tongue and upper airway during sleep. Stimulation is generated by a programmable, multi-current source, implantable neurostimulator (IPG) and delivered to the hypoglossal nerve by a lead with multi-contact cuff electrode (lead).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
aura6000 System
The aura6000 System is intended to unilaterally stimulate the hypoglossal nerve which innervates the muscles of the tongue. The aura6000 System stimulates the hypoglossal nerve cyclically and continuously during sleep to maintain muscle tone of the tongue and upper airway during sleep. Stimulation is generated by a programmable, multi-current source, implantable neurostimulator (IPG) and delivered to the hypoglossal nerve by a lead with multi-contact cuff electrode (lead).
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
LivaNova
INDUSTRY
ImThera Medical, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Alan R Schwartz, MD
Role: PRINCIPAL_INVESTIGATOR
Professor (ret.), Johns Hopkins University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
ENT Associates of San Diego
Chula Vista, California, United States
Tower ENT
Los Angeles, California, United States
SENTA Clinic
San Diego, California, United States
Ear, Nose, and Throat Associates of South Florida
Boca Raton, Florida, United States
Morton Plant Mease Healthcare
Safety Harbor, Florida, United States
Advanced ENT Asociates
Atlanta, Georgia, United States
Center for ENT and Allergy
Carmel, Indiana, United States
Kentucky Research Group
Louisville, Kentucky, United States
Johns Hopkins University
Baltimore, Maryland, United States
ENT and Allergy Associates
New York, New York, United States
Intrepid Research
Cincinnati, Ohio, United States
Medical University of South Carolina
Charleston, South Carolina, United States
UT Methodist Physicians
Memphis, Tennessee, United States
FutureSearch Trials
Austin, Texas, United States
Clinique Univ. Saint-Luc
Brussels, , Belgium
Pitie Salpetriere
Paris, , France
Foch Hospital
Suresnes, , France
Ruprechts-Karls University
Mannheim, , Germany
Bnai Zion Medical Center
Haifa, , Israel
Hospital CUF Porto
Porto, , Portugal
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Schwartz AR, Jacobowitz O, Eisele DW, Mickelson SA, Miller MB, Oliven A, Certal V, Hopp ML, Winslow DH, Huntley TC, Nachlas NE, Pham LV, Gillespie MB, Weeks BH, Lovett EG, Shen J, Malhotra A, Maurer JT. Targeted Hypoglossal Nerve Stimulation for Patients With Obstructive Sleep Apnea: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2023 Jun 1;149(6):512-520. doi: 10.1001/jamaoto.2023.0161.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IMT 2014-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.