Evaluation of Auditory Mirror-therapy for Tinnitus

Mass General Brigham

Status: Active, not recruiting

Conditions: Tinnitus

Treatments: Device: Auditory Mirror Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05710172

2016P000820

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Auditory Mirror Therapy Device

Experimental group

Description:

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.

Treatment:

Device: Auditory Mirror Therapy

Sham Headphone Device

Sham Comparator group

Description:

Non-Modified 3M Peltor Tactical 300 Electronic Hearing Protector

Treatment:

Device: Auditory Mirror Therapy