NCT05710172

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 4, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 2, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2023

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2026

Completed
4 months until next milestone

Results Posted

Study results publicly available

May 15, 2026

Completed
Last Updated

May 15, 2026

Status Verified

April 1, 2026

Enrollment Period

1.1 years

First QC Date

January 15, 2023

Results QC Date

January 29, 2026

Last Update Submit

April 23, 2026

Conditions

Tinnitus

Outcome Measures

Primary Outcomes (1)

  • Change in Tinnitus Functional Index (TFI)

    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.

    3 weeks

Secondary Outcomes (3)

  • Change in Tinnitus Handicap Inventory (THI)

    3 weeks

  • Change in Visual Analogue Scale (VAS)

    3 weeks

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

    3 weeks

Other Outcomes (1)

  • Auditory Mirror Therapy Questionnaire

    3 weeks

Study Arms (2)

Auditory Mirror Therapy Device

EXPERIMENTAL

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.

Device: Auditory Mirror Therapy

Sham Headphone Device

SHAM COMPARATOR

Non-Modified 3M Peltor Tactical 300 Electronic Hearing Protector

Device: Auditory Mirror Therapy

Interventions

Auditory Mirror TherapyDEVICE

21 days, up to 3 hours per day intervention

Auditory Mirror Therapy DeviceSham Headphone Device

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Spaulding Rehabilitation Hospital

Charlestown, Massachusetts, 02129, United States

Location

Related Publications (1)

  • 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.

    PMID: 35079989RESULT

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr Clas Linnman
Organization
Spaulding Rehabilitation Hopsital
clinnman@mgb.org
8572842816

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Concealment of treatment allocation is not possible
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 15, 2023

First Posted

February 2, 2023

Study Start

October 4, 2022

Primary Completion

November 20, 2023

Study Completion

January 20, 2026

Last Updated

May 15, 2026

Results First Posted

May 15, 2026

Record last verified: 2026-04

Locations

US(1)