Trials / Completed
CompletedNCT01796925
Targeted Hypoglossal Neurostimulation Study #2
Clinical Study of the aura6000™ Targeted Hypoglossal Implantable Neurostimulation (THN) Sleep Therapy System
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 57 (actual)
- Sponsor
- ImThera Medical, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Conditions
- Sleep Apnea Syndromes
- Sleep Apnea, Obstructive
- Respiration Disorders
- Signs and Symptoms, Respiratory
- Syndrome, Obstructive Sleep Apnea
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2013-02-01
- Primary completion
- 2013-09-01
- Completion
- 2014-09-01
- First posted
- 2013-02-22
- Last updated
- 2019-08-12
Locations
9 sites across 5 countries: United States, Belgium, France, Germany, Italy
Source: ClinicalTrials.gov record NCT01796925. Inclusion in this directory is not an endorsement.