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

NCT07637708 | Completed

• 1 other identifier: 0787
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tinnitus

Keywords

tinnitus; Music therapy; Desynchronization; Auditory neuromodulation

Outcome Measures

Primary Outcomes (1)

• Tinnitus severity

  Tinnitus handicap inventory

  baseline, 1 month, 2 months, 3 months

Study Arms (2)

Music-Integrated Modified Integrated Desynchronization Therapy (mMIDST)

EXPERIMENTAL

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

Low Frequency Stimulation (LFS)

ACTIVE COMPARATOR

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

Interventions

Music intervention OTHER

Auditory tones music-embedded

Low Frequency Stimulation (LFS); Music-Integrated Modified Integrated Desynchronization Therapy (mMIDST)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Chile: lead

Study Sites (1)

Hospital Clínico Universidad de Chile

Santiago, Chile

Location

Related Publications (3)

• Eggermont JJ, Tass PA. Maladaptive neural synchrony in tinnitus: origin and restoration. Front Neurol. 2015 Feb 17;6:29. doi: 10.3389/fneur.2015.00029. eCollection 2015.

  PMID: 25741316 BACKGROUND

• Adamchic I, Toth T, Hauptmann C, Walger M, Langguth B, Klingmann I, Tass PA. Acute effects and after-effects of acoustic coordinated reset neuromodulation in patients with chronic subjective tinnitus. Neuroimage Clin. 2017 May 28;15:541-558. doi: 10.1016/j.nicl.2017.05.017. eCollection 2017.

  PMID: 28652968 BACKGROUND

• Adamchic I, Hauptmann C, Tass PA. Changes of oscillatory activity in pitch processing network and related tinnitus relief induced by acoustic CR neuromodulation. Front Syst Neurosci. 2012 Apr 5;6:18. doi: 10.3389/fnsys.2012.00018. eCollection 2012.

  PMID: 22493570 BACKGROUND

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Paul Delano, PhD

  University of Chile

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD; Ph. D candidate in medical sciences program

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: June 10, 2026
• Study Start: October 1, 2024
• Primary Completion: November 1, 2025
• Study Completion: February 10, 2026
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)