Evaluation of Auditory Mirror-therapy for Tinnitus

Tinnitus Clinical Trial

Official title:

Evaluation of Auditory Mirror-therapy for Tinnitus

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05710172
• Other study ID #: 2016P000820
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 4, 2022
• Est. completion date: August 30, 2024

Study information

• Verified date: February 2024
• Source: Spaulding Rehabilitation Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: August 30, 2024
• Est. primary completion date: November 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Tinnitus

Intervention

Device:
• Auditory Mirror Therapy
21 days, up to 3 hours per day intervention

Locations

Country	Name	City	State
United States	Spaulding Rehabilitation Hospital	Charlestown	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Spaulding Rehabilitation Hospital	Harvard University

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Auditory Mirror Therapy Questionnaire	developed to qualitatively analyze how AMT is affecting participants' tinnitus throughout the intervention study. here	3 weeks
Primary	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	3 weeks
Secondary	Change in Tinnitus Handicap Inventory (THI)	a brief and psychometrically robust self-report measure used to quantify the impact of tinnitus on daily living.	3 weeks
Secondary	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	3 weeks
Secondary	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.	3 weeks