NCT00927121
Completed
Phase 1
l Prospective Clinical Investigation on the Acoustic Stimulation With the "Coordinated Reset of Neural Subpopulations" in the Treatment of Chronic Tinnitus
ConditionsChronic Tonal Tinnitus
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Chronic Tonal Tinnitus
- Sponsor
- ANM Adaptive Neuromodulation GmbH
- Enrollment
- 63
- Locations
- 1
- Status
- Completed
- Last Updated
- 14 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
Study Sites (1)
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