Effects of Music Combined With CBT on Chronic Subjective Tinnitus

NCT06505473 | Completed

• 1 other identifier: SYSKY-2024-453-01
• Study Type: observational
• Target: 28
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Subjective Tinnitus; Sleep Disorder

Keywords

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

Outcome Measures

Primary Outcomes (5)

• 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 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

• 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 Outcomes (3)

• visual analogue scale (VAS)

  the exact 1 day of the first visit and review visit, within 3 - 4.5 months

• Pittsburgh sleep quality index (PSQI)

  the exact 1 day of the first visit and review visit, within 3 - 4.5 months

• Hamilton Depression Scale -24 items (HAMD-24)

  the exact 1 day of the first visit and review visit, within 3 - 4.5 months

Study Arms (3)

pre-operative results

pre-operative period test results, baseline data.

Behavioral: music-CBT

post-operative results

post-operative period test results, review data.

healthy control

Subjects with no tinnitus and matched baseline information

Interventions

music-CBT BEHAVIORAL

notched relaxation music combined with personalized CBT

pre-operative results

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

MeSH Terms

Conditions

Tinnitus; Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Haidi Yang, master

  SunYatSunU2H

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: July 17, 2024
• Study Start: December 1, 2016
• Primary Completion: March 31, 2024
• Study Completion: June 1, 2024
• Last Updated: August 22, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share