Clinical Investigation on the Acoustic Stimulation in the Treatment of Chronic Tinnitus

ANM Adaptive Neuromodulation

Status and phase: Completed; Phase 2; Phase 1

Conditions: Chronic Tonal Tinnitus

Treatments: Device: Acoustic CR-Stimulator ANM//Technology: Acoustic coordinated reset

Study type: Interventional

Funder types: Industry

Identifiers

NCT00927121

09/1525

Details and patient eligibility

About

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.

Enrollment: 63 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

63 participants in 5 patient groups, including a placebo group

Group 1 : G_1

Active Comparator group

Description:

G_1: stimulation for 4 - 6 hours a day, 4 tones per sequence

Treatment:

Device: Acoustic CR-Stimulator ANM//Technology: Acoustic coordinated reset

Group 2 :G_2

Active Comparator group

Description:

G_2: stimulation for 4 - 6 hours a day with 12-tone sequences

Treatment:

Device: Acoustic CR-Stimulator ANM//Technology: Acoustic coordinated reset

Group3 : G_3

Active Comparator group

Description:

G_3: stimulation for 4 - 6 hours a day, 4 tones per sequence with a signal controlled by EEG measurement

Treatment:

Device: Acoustic CR-Stimulator ANM//Technology: Acoustic coordinated reset

Group 4 : G_4

Active Comparator group

Description:

G_4: stimulation for 1 hour a day, 4 tones per sequence

Treatment:

Device: Acoustic CR-Stimulator ANM//Technology: Acoustic coordinated reset

Group5 : G_5

Placebo Comparator group

Description:

G_5: stimulation with placebo-tone

Treatment:

Device: Acoustic CR-Stimulator ANM//Technology: Acoustic coordinated reset