Evaluation of Auditory Mirror-therapy for Tinnitus

NCT ID: NCT05710172

Last Updated: 2025-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-04

Study Completion Date

2025-11-30

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Tinnitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Concealment of treatment allocation is not possible

Study Groups

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Auditory Mirror Therapy Device

Modified 3M Peltor Tactical 300 Electronic Hearing Protector. The modification consists of connecting the left microphone to the right microphone tab on the circuit board, and vice versa.

Group Type EXPERIMENTAL

Auditory Mirror Therapy

Intervention Type DEVICE

21 days, up to 3 hours per day intervention

Sham Headphone Device

Non-Modified 3M Peltor Tactical 300 Electronic Hearing Protector

Group Type SHAM_COMPARATOR

Auditory Mirror Therapy

Intervention Type DEVICE

21 days, up to 3 hours per day intervention

Interventions

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Auditory Mirror Therapy

21 days, up to 3 hours per day intervention

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Harvard University

OTHER

Sponsor Role collaborator

Spaulding Rehabilitation Hospital

OTHER

Sponsor Role lead

Responsible Party

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Nils Clas Linnman

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Spaulding Rehabilitation Hospital

Charlestown, Massachusetts, United States

Site Status

Countries

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United States

References

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Linnman C. Auditory Mirror Therapy for Tinnitus: A Pilot Study. J Am Acad Audiol. 2022 Apr;33(4):220-223. doi: 10.1055/a-1749-9279. Epub 2022 Dec 6.

Reference Type RESULT
PMID: 35079989 (View on PubMed)

Other Identifiers

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2016P000820

Identifier Type: -

Identifier Source: org_study_id

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