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Effects of Music Combined With CBT on Chronic Subjective Tinnitus

Completed
Conditions
Subjective Tinnitus
Sleep Disorder
Interventions
Behavioral: music-CBT
Registration Number
NCT06505473
Lead Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
28
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
pre-operative resultsmusic-CBTpre-operative period test results, baseline data.
Primary Outcome Measures
NameTimeMethod
tinnitus loudnessthe exact 1 day of the first visit and review visit, within 3 - 4.5 months

Tinnitus loudness was calculated by the matched intensity subtracting the pure tone threshold at that frequency.

tinnitus handicap inventory (THI)the exact 1 day of the first visit and review visit, within 3 - 4.5 months

There were 25 items in the THI scale, divided into three subscales (functional, emotional, and catastrophic), and response choices consisted of "no" (0 points), "sometimes" (2 points), and "yes" (4 points). A higher score of THI indicateed more severe tinnitus.

pure tone audiometrythe exact 1 day of the first visit

The air conductivity threshold of pure tone audiometry across the frequency range of 500-4000Hz is referred to as the pure tone average (PTA) for the tested ear

EEG functional connectivity and brain network characteristicsthe exact 1 day of the first visit and review visit, within 3 - 4.5 months

EEG signals were used to explore the activation of brain regions and remodeling of poor connections in the postoperative outcomes of conductive hearing loss patients accompanied by with tinnitus. Power spectral density calculation, traceability analysis, functional connection, microstate, clustering coefficient, feature path length, feature path intermediation, and isocompatibility coefficient were collected and then analyzed.

tinnitus functional index (TFI)the exact day of the first visit and review visit, within 3 - 4.5 months

The TFI scale assessed tinnitus-related distress and severity. It contained 8 subscales. They were denoted as TFI-I (Intrusiveness) and TFI-SC (Sense of) control), TFI-C (Cognition), TFI-S (Sleep), TFI-A (Auditory), TFI-R (Relaxation), TFI-Q (Quality of life), TFI-E (Emotional) distress); A total of 25 items are included. Each item worthes 100 points. The average score of all items was recorded as the total TFI score (0-100). A higher score of TFI indicateed more severe tinnitus.

Secondary Outcome Measures
NameTimeMethod
Hamilton Depression Scale -24 items (HAMD-24)the exact 1 day of the first visit and review visit, within 3 - 4.5 months

The HAMD-24 was used to assess the degree of depression and emotional state in patients with chronic subjective tinnitus. The assessment included the emotional state and symptoms of autonomic nervous system disorders in the past week, and each question was scored according to the presence and severity of symptoms.

Pittsburgh sleep quality index (PSQI)the exact 1 day of the first visit and review visit, within 3 - 4.5 months

PSQI scale was compiled by Buysse et al in 1989 to assess the sleep quality of individuals in the last 1 month. The total score ranges from 0 to 21. A higher score indicates worse sleep quality in the past month.

visual analogue scale (VAS)the exact 1 day of the first visit and review visit, within 3 - 4.5 months

VAS scaled from 0 to 10. A score of 0 means that tinnitus has no impact on daily life, and a score of 10 means that tinnitus has an intolerable, fatal level of impact on daily life.

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