Trials / Completed
CompletedNCT01435317
Acoustic Coordinated Reset (CR®) Neuromodulation for the Treatment of Chronic Tonal Tinnitus ("RESET Real Life")
Prospective Clinical Study for Confirmation of Efficacy and Safety of Acoustic CR®-Neuromodulation by CE Marked ANM T30 CR®-System in a "Real Life" Patient Population With Chronic Tonal Tinnitus
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 200 (actual)
- Sponsor
- ANM Adaptive Neuromodulation GmbH · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Confirmation of efficacy and safety of acoustic CR®-neuromodulation for the treatment of chronic tinnitus patients using the CE marked ANM T30 CR®-system in a real life outpatient setting. * Identification of early indicators for therapy success * Comparison of different patient groups regarding: tinnitus severity, tinnitus duration, level of hearing loss, stimulation patterns, unilateral monotonal vs. all other complex forms * Representative set of safety data in a broad patient spectrum * Measurement of tinnitus burden (TBF-12 Questionnaire) * Generation of longterm compliance data
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | ANM T30 CR®-System | Stimulation for 4-6h/day for a time of 1 year |
Timeline
- Start date
- 2011-11-01
- Primary completion
- 2013-06-01
- Completion
- 2014-07-01
- First posted
- 2011-09-16
- Last updated
- 2014-07-11
Locations
23 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT01435317. Inclusion in this directory is not an endorsement.