Evaluation of Auditory Mirror-therapy for Tinnitus

Not Applicable

Active, not recruiting

• Conditions: Tinnitus
• Interventions: Device: Auditory Mirror Therapy

• Registration Number: NCT05710172
• Lead Sponsor: Spaulding Rehabilitation Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2022-10-04
• Study First Submitted: 2023-01-15
• Study First Submitted QC: 2023-01-24
• Study First Posted: 2023-02-02
• Primary Completion: 2023-11-20
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-15
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Auditory Mirror Therapy Device	Auditory Mirror Therapy	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.
Sham Headphone Device	Auditory Mirror Therapy	Non-Modified 3M Peltor Tactical 300 Electronic Hearing Protector

Primary Outcome Measures

Name	Time	Method
Change in Tinnitus Functional Index (TFI)	3 weeks	25 question inventory that developed to provide a scaling of tinnitus severity, an identification of tinnitus domains with impact on the tinnitus severity, and a responsive measurement of change in tinnitus severity.; The TFI will be used to determine the efficacy of a 21 day, 3 hours per day, intervention of auditory mirror-therapy (AMT) for chronic tinnitus

Secondary Outcome Measures

Name	Time	Method
Change in Tinnitus Handicap Inventory (THI)	3 weeks	a brief and psychometrically robust self-report measure used to quantify the impact of tinnitus on daily living.
Change in Visual Analogue Scale (VAS)	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
Change in Minimum Masking Level (MML) and residual inhibition (RI)	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.

Trial Locations

Locations (1)

Spaulding Rehabilitation Hospital; 🇺🇸 Charlestown, Massachusetts, United States