Personalized Music-Embedded Sound Therapy Based on Gating Modulation and Neural Decoupling Reduces Tinnitus Severity

June 4, 2026 updated by: Pablo Henriquez, University of Chile

Personalized Music-embedded Sound Therapy Based on Gating Modulation and Neural Decoupling Reduces Tinnitus Severity in Adults Between 18 and 75 Years, With Chronic Tinnitus, Assessed With Tinnitus Handicap Inventory (THI)

This clinical trial evaluated a personalized music-embedded sound therapy for adults with chronic subjective tinnitus. Tinnitus is the perception of sound, such as ringing or buzzing, without an external source and can negatively affect quality of life.

Participants were randomly assigned to one of two groups. One group received personalized music-embedded desynchronization sound therapy, using tones selected according to each participant's tinnitus frequency and embedded in music. The comparison group received low-frequency sound stimulation embedded in music. Both interventions were designed to be similar for participants.

The main objective was to evaluate whether the personalized music-embedded sound therapy reduced tinnitus severity compared with low-frequency sound stimulation. Tinnitus severity was measured using the Tinnitus Handicap Inventory at baseline and during follow-up.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Arm 1 - Music-Integrated Modified Integrated Desynchronization Therapy (mMIDST)

Brief name: Music-Integrated Modified Integrated Desynchronization Therapy (mMIDST)

Description of the intervention: Participants allocated to this arm will receive a sound-based neuromodulation therapy consisting of acoustic stimulation sequences embedded within musical tracks. The intervention is designed to deliver patterned auditory stimuli based on the principles of coordinated reset neuromodulation, which aims to reduce abnormal neural synchrony associated with chronic tinnitus. The intervention consists of pre-processed audio files containing therapeutic acoustic stimulation integrated into music tracks. These audio files are delivered through personal listening devices (e.g., smartphone or portable audio player) using standard headphones. Participants will be instructed to listen to the therapeutic audio tracks daily in a quiet environment. The intervention will be self-administered by participants at home.

Delivery procedures: Participants will receive instructions from a physician or trained researcher with experience in tinnitus management. During the baseline visit, participants will be instructed on the correct use of the audio files and listening protocol. Participants will be instructed to listen to the therapeutic audio program for approximately 1 hour per day, preferably during periods of relaxation or low environmental noise.

Duration of intervention: The intervention will be performed daily for 3 months.

Mode of delivery: Individual, self-administered listening sessions. Delivered through personal audio devices and headphones. Conducted primarily in the participant's home environment

Materials used in the intervention: Pre-generated therapeutic audio tracks containing embedded acoustic stimulation sequences. The use standard headphones or earphones with personal audio playback device (smartphone or portable audio player)

Intervention providers: The intervention protocol will be prescribed and explained by a physician specializing in otolaryngology and tinnitus management. Participants will perform the listening sessions independently.

Personalisation or adaptation: The stimulation frequencies embedded in the audio tracks are individualized according to the participant's tinnitus pitch characteristics when available, in order to optimize the neuromodulation effect.

Adherence monitoring: Participants will be asked to report their listening time during follow-up visits at 1 month, 2 months, and 3 months. Compliance will be assessed through participant self-report.

Arm 2 - Low Frequency Stimulation (LFS) Brief name: Low Frequency Stimulation (LFS)

Description of the intervention: Participants in this arm will receive acoustic stimulation consisting of low-frequency tonal sound stimulation delivered through audio tracks. The stimulation is designed as a comparator sound-based intervention for tinnitus. Participants will receive audio files containing low-frequency acoustic stimuli delivered through personal listening devices using standard headphones.

Delivery procedures: Participants will be instructed by the study investigators on how to perform the listening sessions. The stimulation will be self-administered by participants in their home environment.

Duration and schedule: Participants will listen to the stimulation program for approximately 1 hour per day over a 3-month period.

Mode of delivery: Individual listening sessions, delivered through headphones and personal audio playback devices. Conducted primarily in the participant's home environment

Materials used: Pre-generated audio files containing low-frequency stimulation, with standard headphones or earphones and personal audio playback device

Intervention providers: The protocol will be explained by a physician or trained researcher experienced in tinnitus treatment.

Adherence monitoring: Compliance will be evaluated through participant self-report during follow-up visits at 1, 2, and 3 months.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
      • Santiago, Chile
        • Hospital Clínico Universidad de Chile

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Adults aged 18 to 75 years.

Diagnosis of chronic subjective tinnitus lasting more than 6 months.

Non-pulsatile tinnitus.

Tonal tinnitus with an identifiable tinnitus frequency.

Unilateral or bilateral tinnitus.

Ability to understand the study procedures and provide written informed consent.

Ability to comply with the assigned sound therapy protocol and follow-up assessments.

Exclusion Criteria:

Pulsatile tinnitus.

Non-tonal tinnitus.

History of auditory hallucinations.

History of Ménière's disease.

History of other active middle or inner ear disease with neurological sequelae.

Current use of centrally acting medications that could interfere with tinnitus perception or auditory processing.

Severe hearing loss preventing adequate perception of the auditory stimuli.

Inability to complete the follow-up assessments.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Music-Integrated Modified Integrated Desynchronization Therapy (mMIDST)
Participants allocated to this arm will receive a sound-based neuromodulation therapy consisting of acoustic stimulation sequences embedded within musical tracks. The intervention is designed to deliver patterned auditory stimuli based on the principles of coordinated reset neuromodulation, which aims to reduce abnormal neural synchrony associated with chronic tinnitus. The intervention consists of pre-processed audio files containing therapeutic acoustic stimulation integrated into music tracks. These audio files are delivered through personal listening devices (e.g., smartphone or portable audio player) using standard headphones. Participants will be instructed to listen to the therapeutic audio tracks daily in a quiet environment. The intervention will be self-administered by participants at home.
Other: Music intervention
Auditory tones music-embedded
Active Comparator: Low Frequency Stimulation (LFS)
Participants in this arm will receive acoustic stimulation consisting of low-frequency tonal sound stimulation delivered through audio tracks. The stimulation is designed as a comparator sound-based intervention for tinnitus. Participants will receive audio files containing low-frequency acoustic stimuli delivered through personal listening devices using standard headphones.
Other: Music intervention
Auditory tones music-embedded

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tinnitus severity
Time Frame: baseline, 1 month, 2 months, 3 months
Tinnitus handicap inventory
baseline, 1 month, 2 months, 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chile

Investigators

  • Study Director: Paul Delano, PhD, University of Chile

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2024

Primary Completion (Actual)

November 1, 2025

Study Completion (Actual)

February 10, 2026

Study Registration Dates

First Submitted

June 4, 2026

First Submitted That Met QC Criteria

June 4, 2026

First Posted (Actual)

June 10, 2026

Study Record Updates

Last Update Posted (Actual)

June 10, 2026

Last Update Submitted That Met QC Criteria

June 4, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0787

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared because of privacy and confidentiality considerations related to the small sample size. Aggregate results may be reported in scientific publications.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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