Trials / Completed
CompletedNCT01532180
Safety and Efficacy of a Hypoglossal Nerve Implant for the Treatment of Obstructive Sleep Apnea (OSA)
A Pilot Study and Follow Up of the Use of a Hypoglossal Nerve Implant for Treatment of Obstructive Sleep Apnea
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 14 (actual)
- Sponsor
- ImThera Medical, Inc. · Industry
- Sex
- All
- Age
- 25 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
The objective of the study is to determine the safety and preliminary 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 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
- 2009-11-01
- Primary completion
- 2011-12-01
- Completion
- 2011-12-01
- First posted
- 2012-02-14
- Last updated
- 2019-08-12
Locations
1 site across 1 country: Belgium
Source: ClinicalTrials.gov record NCT01532180. Inclusion in this directory is not an endorsement.