Effects of Music Combined With CBT on Chronic Subjective Tinnitus

Effects of Music Combined With Cognitive Behavioral Therapy on Chronic Subjective Tinnitus and a Multi-Factor Analysis

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.

Study Overview

• Status: Completed
• Conditions: Sleep Disorder; Subjective Tinnitus
• Intervention / Treatment: Behavioral: music-CBT

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.

• Study Type: Observational
• Enrollment (Actual): 28

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
pre-operative results; pre-operative period test results, baseline data.	Behavioral: music-CBT; notched relaxation music combined with personalized CBT
post-operative results; post-operative period test results, review data.
healthy control; Subjects with no tinnitus and matched baseline information

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
tinnitus loudness	Tinnitus loudness was calculated by the matched intensity subtracting the pure tone threshold at that frequency.	the exact 1 day of the first visit and review visit, within 3 - 4.5 months
pure tone audiometry	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	the exact 1 day of the first visit
tinnitus handicap inventory (THI)	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.	the exact 1 day of the first visit and review visit, within 3 - 4.5 months
tinnitus functional index (TFI)	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.	the exact day of the first visit and review visit, within 3 - 4.5 months
EEG functional connectivity and brain network characteristics	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.	the exact 1 day of the first visit and review visit, within 3 - 4.5 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pittsburgh sleep quality index (PSQI)	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.	the exact 1 day of the first visit and review visit, within 3 - 4.5 months
visual analogue scale (VAS)	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.	the exact 1 day of the first visit and review visit, within 3 - 4.5 months
Hamilton Depression Scale -24 items (HAMD-24)	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.	the exact 1 day of the first visit and review visit, within 3 - 4.5 months

Collaborators and Investigators

• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Investigators: Study Director: Haidi Yang, master, SunYatSunU2H

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): March 31, 2024
• Study Completion (Actual): June 1, 2024

Study Registration Dates

• First Submitted: July 11, 2024
• First Submitted That Met QC Criteria: July 16, 2024
• First Posted (Actual): July 17, 2024

Study Record Updates

• Last Update Posted (Actual): August 22, 2024
• Last Update Submitted That Met QC Criteria: August 20, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: cognitive behavioral therapy; music therapy; chronic subjective tinnitus; neural mechanism
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Sleep Wake Disorders; Tinnitus
• Other Study ID Numbers: SYSKY-2024-453-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No