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OpenTrials
Completed

NCT Number: NCT01435317

Acoustic Coordinated Reset (CR®) Neuromodulation for the Treatment of Chronic Tonal Tinnitus ("RESET Real Life")

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

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Key information

Conditions

Tinnitus Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dr. med. Mueller, Augsburg, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Main Inclusion Criteria:

  • symptomatic subjective tonal chronical (> 3 months) tinnitus
  • <60dB hearing loss
  • men and women ≥18 years old

Main Exclusion Criteria:

  • serious neurologic
  • psychiatric or internistic disease
  • objective tinnitus
  • Morbus Menière
  • craniomandibular triggered tinnitus

Treatment and study plan

ANM T30 CR®-System

Device

Stimulation for 4-6h/day for a time of 1 year

Primary outcomes

  1. Improvement of TBF-12 Score or CGI Score

    Time frame: 12 months

    Change of tinnitus severity, measured by TBF-12 Score or CGI score change from baseline to end of treatment.

Secondary outcomes

  1. NRS loudness and annoyance (0-100)

    Time frame: 0.5, 1, 2, 3, 6, 9, 12 months

  2. Tinnitus-freedom

    Time frame: 3,6,9,12 months

  3. Compliance

    Time frame: 0.5,1,3,6,9,12 months

    Questioning if the specified application was kept.

  4. Alteration of tinnitus

    Time frame: 0.5,1,2,3,6,9,12 months

    Early alteration of tinnitus frequency and psychometric tinnitus loudness, measured with the ANM T30 CR®-System.

  5. Audiogram for hearing loss change

    Time frame: 3,12 months

  6. TBF-12

    Time frame: 3,6,9,12 months

Sponsors and collaborators

Lead sponsor

ANM Adaptive Neuromodulation GmbH

Industry

Collaborators

  • CERES GmbH

Registry information

Official study title

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

Acronym: RRL

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Sep 16, 2011
Registry last updated
Jul 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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