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Completed

NCT Number: NCT05710172

Evaluation of Auditory Mirror-therapy for Tinnitus

The investigators will evaluate the effects of wearing auditory mirror earmuffs on tinnitus and on audiometry.The auditory mirror earmuffs is a device that re-routes auditory input from the left side of the head to the right ear, and vice verse, thereby flipping the auditory input. This procedure is called Auditory Mirror Therapy (AMT).

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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–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Spaulding Rehabilitation Hospital

Charlestown, Massachusetts, 02129, United States

About this study

The goal of this study is to determine efficacy of a 21 day, 3 hours per day intervention of auditory mirror therapy (AMT) for chronic tinnitus. Hypothesis: AMT, as contrasted to a sham device, will significantly reduce symptom ratings on the Tinnitus Functional Index (TFI) scale. Along with TFI, additional measures will be collected every two days throughout the intervention; Tinnitus Handicap Index, Visual Analogue Scale, Minimum Masking Level (MML) and Residual Inhibition (RI), and Auditory Mirror Therapy Questionnaire.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or Female
  • Ages 18-80 years old
  • Chronic Tinnitus (> 3months)

Exclusion criteria

  • Use of hearing aids
  • No history of significant drug or alcohol use
  • No history of debilitating neurological or psychiatric illnesses
  • No current or past history of balance-, vertigo- and/or vestibular- symptoms including Ménières disease

Treatment and study plan

Auditory Mirror Therapy

Device

21 days, up to 3 hours per day intervention

Primary outcomes

  1. Change in Tinnitus Functional Index (TFI)

    Time frame: 3 weeks

    The Tinnitus Functional Index (TFI) is a 25-item questionnaire measuring tinnitus severity on a 0-100 scale. Scores are calculated by averaging item responses and scaling to 0-100, where higher scores signify greater distress.

    The change in TFI score between baseline and follow up is reported, with negative numbers indicating a decrease in tinnitus severity.

Secondary outcomes

  1. Change in Tinnitus Handicap Inventory (THI)

    Time frame: 3 weeks

    a brief and psychometrically robust self-report measure used to quantify the impact of tinnitus on daily living.

  2. Change in Visual Analogue Scale (VAS)

    Time frame: 3 weeks

    Scale from 0 to 100 for tinnitus awareness, loudness and annoyance, on separate VAS.

    VAS loudness and annoyance are valid and effective measurements for capturing reductions in tinnitus severity in patients with chronic tinnitus

  3. Change in Minimum Masking Level (MML) and Residual Inhibition (RI)

    Time frame: 3 weeks

    MML is defined as the lowest tone intensity level required to cover or mask and individual's tinnitus.

    Correspondingly, the RI is considered the temporary decrease of tinnitus after a prolonged acoustic stimulation.

Other outcomes

  1. Auditory Mirror Therapy Questionnaire

    Time frame: 3 weeks

    developed to qualitatively analyze how AMT is affecting participants' tinnitus throughout the intervention study. here

Sponsors and collaborators

Lead sponsor

Spaulding Rehabilitation Hospital

Other

Collaborators

  • Harvard University

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2026
First posted
Feb 2, 2023
Registry last updated
May 15, 2026

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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