Trial Outcomes & Findings for Evaluation of Auditory Mirror-therapy for Tinnitus (NCT NCT05710172)

Last Updated: 2026-05-15

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

56 participants

Primary outcome timeframe

3 weeks

Results posted on

2026-05-15

Participant Flow

Participant milestones

Participant milestones
Measure	Active AMT Device active auditory mirror therapy device	Sham sham AMT device
Overall Study STARTED	33	23
Overall Study COMPLETED	26	16
Overall Study NOT COMPLETED	7	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Active AMT Device active auditory mirror therapy device	Sham sham AMT device
Overall Study Withdrawal by Subject	7	7

Baseline Characteristics

Evaluation of Auditory Mirror-therapy for Tinnitus

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active AMT Device n=33 Participants active auditory mirror therapy device	Sham n=23 Participants sham AMT device	Total n=56 Participants Total of all reporting groups
Age, Continuous	49.1 years STANDARD_DEVIATION 14.9 • n=11 Participants	59 years STANDARD_DEVIATION 12.14 • n=9 Participants	53 years STANDARD_DEVIATION 14 • n=20 Participants
Sex: Female, Male Female	16 Participants n=11 Participants	7 Participants n=9 Participants	23 Participants n=20 Participants
Sex: Female, Male Male	17 Participants n=11 Participants	16 Participants n=9 Participants	33 Participants n=20 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=11 Participants	0 Participants n=9 Participants	0 Participants n=20 Participants
Race (NIH/OMB) Asian	6 Participants n=11 Participants	0 Participants n=9 Participants	6 Participants n=20 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=11 Participants	0 Participants n=9 Participants	1 Participants n=20 Participants
Race (NIH/OMB) Black or African American	0 Participants n=11 Participants	0 Participants n=9 Participants	0 Participants n=20 Participants
Race (NIH/OMB) White	24 Participants n=11 Participants	23 Participants n=9 Participants	47 Participants n=20 Participants
Race (NIH/OMB) More than one race	2 Participants n=11 Participants	0 Participants n=9 Participants	2 Participants n=20 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=11 Participants	0 Participants n=9 Participants	0 Participants n=20 Participants
Region of Enrollment United States	33 participants n=11 Participants	23 participants n=9 Participants	56 participants n=20 Participants
Tinnitus functional index	41.2 units on a scale STANDARD_DEVIATION 16.4 • n=11 Participants	40.8 units on a scale STANDARD_DEVIATION 19.5 • n=9 Participants	41 units on a scale STANDARD_DEVIATION 18.1 • n=20 Participants

PRIMARY outcome

Timeframe: 3 weeks

Population: completed study with TFI data

Outcome measures

Outcome measures
Measure	Auditory Mirror Therapy Device n=26 Participants 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. Auditory Mirror Therapy: 21 days, up to 3 hours per day intervention	Sham Headphone Device n=17 Participants Non-Modified 3M Peltor Tactical 300 Electronic Hearing Protector Auditory Mirror Therapy: 21 days, up to 3 hours per day intervention
Change in Tinnitus Functional Index (TFI)	-10.7 units on a scale Standard Deviation 17.7	-10.9 units on a scale Standard Deviation 12.1

SECONDARY outcome

Timeframe: 3 weeks

a brief and psychometrically robust self-report measure used to quantify the impact of tinnitus on daily living.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 weeks

developed to qualitatively analyze how AMT is affecting participants' tinnitus throughout the intervention study. here

Outcome measures

Outcome data not reported

Adverse Events

Auditory Mirror Therapy Device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham Headphone Device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Clas Linnman

Spaulding Rehabilitation Hopsital

Phone: 8572842816

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place