Clinical trial NCT06505473: Effects of Music Combined With CBT on Chronic Subjective Tinnitus
Official title: Effects of Music Combined With Cognitive Behavioral Therapy on Chronic Subjective Tinnitus and a Multi-Factor Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Subjective Tinnitus
Sleep Disorder
Keywords: chronic subjective tinnitus
music therapy
cognitive behavioral therapy
neural mechanism
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2024-07-17
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The participants involved in this study were patients admitted to Sun Yat-sen Memorial Hospital with chronic subjective tinnitus that had lasted for more than six months. They were all treated with Music-CBT for 3 months.

Brief summary: This study retrospectively analyzed the first and second visit data of chronic subjective tinnitus patients who received music combined with cognitive behavioral therapy in our hospital in recent years. Behavioral tests and tinnitus questionnaires, as well as sleep and depression scores, were used to analyze the therapeutic effects of this approach. EEG results were analyzed as a potential neurobiological marker to explore the neural mechanism of tinnitus symptom improvement.

Detailed description: The subjects of this study were chronic subjective tinnitus patients and normal controls who were treated with music therapy combined with cognitive behavioral therapy (music-CBT) in the Department of Otolaryngology of Sun Yat-sen Memorial Hospital from December 2016 to March 2024 and who had completed re-examination. The pre- and post-music-CBT data of past patients who met our study conditions were collected for retrospective statistics. The complete sample data included medical history, pure tone audiometry, tinnitus matching, tinnitus questionnaires (Tinnitus Handicap Inventory, Visual Analog Scales, tinnitus Functional Index), sleep quality questionnaire (Pittsburgh Sleep Quality Index), and depression questionnaire (Hamilton Depression Scale -24 items). The resting state electroencephalogram (rs-EEG). Retrospective statistical analysis was conducted to determine the clinical efficacy and influencing factors of music-CBT for chronic subjective tinnitus at 3 months and long term. Finally, the neural mechanism of music-CBT for tinnitus treatment was analyzed based on rs-EEG results.

Eligibility criteria: Inclusion Criteria:

* adults aged between 18 and 60
* a total score of 18 or higher on THI
* a constant tinnitus that can be matched
* right-handed
* no significant medical or psychiatric conditions

Exclusion Criteria:

* intermittent, pulsating or objective tinnitus
* central nervous system disease
* cognitive impairment
* other contraindications for EEG testing

Primary outcomes:
measure: pure tone audiometry
timeFrame: the exact 1 day of the first visit
measure: tinnitus loudness
timeFrame: the exact 1 day of the first visit and review visit, within 3 - 4.5 months
measure: tinnitus handicap inventory (THI)
timeFrame: the exact 1 day of the first visit and review visit, within 3 - 4.5 months
measure: tinnitus functional index (TFI)
timeFrame: the exact day of the first visit and review visit, within 3 - 4.5 months
measure: EEG functional connectivity and brain network characteristics
timeFrame: the exact 1 day of the first visit and review visit, within 3 - 4.5 months
Secondary outcomes:
measure: visual analogue scale (VAS)
timeFrame: the exact 1 day of the first visit and review visit, within 3 - 4.5 months
measure: Pittsburgh sleep quality index (PSQI)
timeFrame: the exact 1 day of the first visit and review visit, within 3 - 4.5 months
measure: Hamilton Depression Scale -24 items (HAMD-24)
timeFrame: the exact 1 day of the first visit and review visit, within 3 - 4.5 months
Other outcomes:
Locations:
Study officials:
affiliation: SunYatSunU2H
name: Haidi Yang, master
role: STUDY_DIRECTOR
References: