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)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究者
Pablo Henriquez
MD; Ph. D candidate in medical sciences program
University of Chile