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

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.

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.