Clinical Investigation on the Acoustic Stimulation in the Treatment of Chronic Tinnitus
- Conditions
- Chronic Tonal Tinnitus
- Registration Number
- NCT00927121
- Lead Sponsor
- ANM Adaptive Neuromodulation GmbH
- Brief Summary
There are many treatments for chronic tinnitus that have been claimed, with varying degrees of statistical reliability. None of those treatments can eradicate the tinnitus completely. Some therapies can reduce the tinnitus symptoms (loudness, annoyance) up to 30%. Thus there is still a need of new treatments that can reduce considerably the tinnitus symptoms and improve the QOL of subjects.
Trial objectives:
* The aim of this trial is the improvement of the QOL (quality of live) by reducing the Tinnitus- Symptoms of the patient.
* To confirm the efficacy and safety of the coordinated reset technology.
These objectives will be assessed:
* By subjective and objective measurements of the Tinnitus symptoms, loudness and annoyance.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 63
- Mentally healthy people
- Chronic tonal Tinnitus
- Older than 18 years
- Signature of the patient informed consent
- No participation in other tinnitus therapy during the clinical investigation
- A necessity for hearing aid
- Auditory hallucination
- Symptomatic hearing disorders
- "Morbus Meniere",
- Tinnitus due to temporomandibular joint disorders
- Subjects who can't perceive therapeutic tones
- Brainstem diseases
- Psychiatric disorders
- Objective Tinnitus
- Insufficient treatment of general disorders, anemia, tumor, dialysis, hypertonus ect.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Research Center Jülich // Institute for Neurosciences and Medicine - Research Center
🇩🇪Jülich, Germany