search
Back to results

Evaluation of Auditory Mirror-therapy for Tinnitus

Primary Purpose

Tinnitus

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Auditory Mirror Therapy
Sponsored by
Spaulding Rehabilitation Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinnitus

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Spaulding Rehabilitation Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Auditory Mirror Therapy Device

Sham Headphone Device

Arm 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.

Non-Modified 3M Peltor Tactical 300 Electronic Hearing Protector

Outcomes

Primary Outcome Measures

Change in Tinnitus Functional Index (TFI)
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

Change in Tinnitus Handicap Inventory (THI)
a brief and psychometrically robust self-report measure used to quantify the impact of tinnitus on daily living.
Change in Visual Analogue Scale (VAS)
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)
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.

Full Information

First Posted
January 15, 2023
Last Updated
April 12, 2023
Sponsor
Spaulding Rehabilitation Hospital
Collaborators
Harvard University
search

1. Study Identification

Unique Protocol Identification Number
NCT05710172
Brief Title
Evaluation of Auditory Mirror-therapy for Tinnitus
Official Title
Evaluation of Auditory Mirror-therapy for Tinnitus
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 4, 2022 (Actual)
Primary Completion Date
April 10, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Spaulding Rehabilitation Hospital
Collaborators
Harvard University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Concealment of treatment allocation is not possible
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Auditory Mirror Therapy Device
Arm Type
Experimental
Arm 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.
Arm Title
Sham Headphone Device
Arm Type
Sham Comparator
Arm Description
Non-Modified 3M Peltor Tactical 300 Electronic Hearing Protector
Intervention Type
Device
Intervention Name(s)
Auditory Mirror Therapy
Intervention Description
21 days, up to 3 hours per day intervention
Primary Outcome Measure Information:
Title
Change in Tinnitus Functional Index (TFI)
Description
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
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Change in Tinnitus Handicap Inventory (THI)
Description
a brief and psychometrically robust self-report measure used to quantify the impact of tinnitus on daily living.
Time Frame
3 weeks
Title
Change in Visual Analogue Scale (VAS)
Description
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
Time Frame
3 weeks
Title
Change in Minimum Masking Level (MML) and residual inhibition (RI)
Description
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.
Time Frame
3 weeks
Other Pre-specified Outcome Measures:
Title
Auditory Mirror Therapy Questionnaire
Description
developed to qualitatively analyze how AMT is affecting participants' tinnitus throughout the intervention study. here
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Spaulding Rehabilitation Hospital
City
Charlestown
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35079989
Citation
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.
Results Reference
result

Learn more about this trial

Evaluation of Auditory Mirror-therapy for Tinnitus

We'll reach out to this number within 24 hrs