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Evaluation of Auditory Mirror-therapy for Tinnitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05710172
Recruitment Status : Active, not recruiting
First Posted : February 2, 2023
Last Update Posted : April 14, 2023
Sponsor:
Collaborator:
Harvard University
Information provided by (Responsible Party):
Nils Clas Linnman, 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).

Condition or disease Intervention/treatment Phase
Tinnitus Device: Auditory Mirror Therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: Concealment of treatment allocation is not possible
Primary Purpose: Treatment
Official Title: Evaluation of Auditory Mirror-therapy for Tinnitus
Actual Study Start Date : October 4, 2022
Estimated Primary Completion Date : April 10, 2023
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus

Arm Intervention/treatment
Experimental: 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.
Device: Auditory Mirror Therapy
21 days, up to 3 hours per day intervention

Sham Comparator: Sham Headphone Device
Non-Modified 3M Peltor Tactical 300 Electronic Hearing Protector
Device: Auditory Mirror Therapy
21 days, up to 3 hours per day intervention




Primary Outcome Measures :
  1. Change in Tinnitus Functional Index (TFI) [ Time Frame: 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 :
  1. Change in Tinnitus Handicap Inventory (THI) [ Time Frame: 3 weeks ]
    a brief and psychometrically robust self-report measure used to quantify the impact of tinnitus on daily living.

  2. Change in Visual Analogue Scale (VAS) [ Time Frame: 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


  3. Change in Minimum Masking Level (MML) and residual inhibition (RI) [ Time Frame: 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.



Other Outcome Measures:
  1. Auditory Mirror Therapy Questionnaire [ Time Frame: 3 weeks ]
    developed to qualitatively analyze how AMT is affecting participants' tinnitus throughout the intervention study. here



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05710172


Locations
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United States, Massachusetts
Spaulding Rehabilitation Hospital
Charlestown, Massachusetts, United States, 02129
Sponsors and Collaborators
Spaulding Rehabilitation Hospital
Harvard University
Publications of Results:
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Responsible Party: Nils Clas Linnman, Assistant Professor, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT05710172    
Other Study ID Numbers: 2016P000820
First Posted: February 2, 2023    Key Record Dates
Last Update Posted: April 14, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases