Skip to content

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06505473
Enrollment
28
Registered
2024-07-17
Start date
2016-12-01
Completion date
2024-06-01
Last updated
2024-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Disorder, Subjective Tinnitus

Keywords

chronic subjective tinnitus, music therapy, cognitive behavioral therapy, neural mechanism

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.

Interventions

BEHAVIORALmusic-CBT

notched relaxation music combined with personalized CBT

Sponsors

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
EEG functional connectivity and brain network characteristicsthe exact 1 day of the first visit and review visit, within 3 - 4.5 monthsEEG 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 loudnessthe exact 1 day of the first visit and review visit, within 3 - 4.5 monthsTinnitus 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 monthsThere 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.
tinnitus functional index (TFI)the exact day of the first visit and review visit, within 3 - 4.5 monthsThe 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.
pure tone audiometrythe exact 1 day of the first visitThe 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

Secondary

MeasureTime frameDescription
Pittsburgh sleep quality index (PSQI)the exact 1 day of the first visit and review visit, within 3 - 4.5 monthsPSQI 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.
Hamilton Depression Scale -24 items (HAMD-24)the exact 1 day of the first visit and review visit, within 3 - 4.5 monthsThe 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.
visual analogue scale (VAS)the exact 1 day of the first visit and review visit, within 3 - 4.5 monthsVAS 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026