Mechanism Research of Tinnitus Based on Electroencephalogram and Acoustic Therapy Intervention

NCT04449237 | Unknown DMC

• 1 other identifier: sunshan
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

This project aims to systematically and deeply study the central mechanism of tinnitus using electroencephalogram, and further study the treatment mechanism of tinnitus in combination with sound treatment strategies, so as to provide a research basis for clinical treatment of tinnitus.

Conditions

Tinnitus, Subjective

Outcome Measures

Primary Outcomes (8)

• electroencephalogram evaluation

  latency

  From date of randomization, assessed every 3 month, up to 24 month

• electroencephalogram evaluation

  peak

  From date of randomization, assessed every 3 month, up to 24 month

• electroencephalogram evaluation

  amplitude

  From date of randomization, assessed every 3 month, up to 24 month

• the loudness of tinnitus

  estimated by auditory facility, recorded by unit of dB

  From date of randomization, assessed every 3 month, up to 24 month

• the frequency of tinnitus

  estimated by auditory facility, recorded by unit of Hz

  From date of randomization, assessed every 3 month, up to 24 month

• minimum masking level

  the minimum volume to masking tinnitus, recorded by unit of dB

  From date of randomization, assessed every 3 month, up to 24 month

• Tinnitus Handicapped Inventory

  Tinnitus disability is divided into four levels, the first level: 0-16 points, no disability; Level 2:18-36, slightly disabled; Level 3:38-56, moderate disability; Level 4:58-100, severe disability.

  From date of randomization, assessed every 3 month, up to 24 month

• Hospital Anxiety and Distress Scale

  0-7 are asymptomatic; 8 -10 respectively belong to suspicious existence; 11 -21 must exist.

  From date of randomization, assessed every 3 month, up to 24 month

Study Arms (3)

volunteer

OTHER

40 volunteer will not accept any treatment

Other: music therapy

patients with unmodified music group

PLACEBO COMPARATOR

40 participants in this group will listen to music without any modification

Other: music therapy

patients with modified tinnitus relieving music

EXPERIMENTAL

40 participants in this group will listen to the music modified according to the matched dominant tinnitus pitch

Other: music therapy

Interventions

music therapy OTHER

music therapy: therapeutic sound according to the frequency and loudness of each patient's tinnitus sound, so as to reduce the tinnitus sound.

patients with modified tinnitus relieving music; patients with unmodified music group; volunteer

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years old, male or female;
• PTA (0.5,1,2kHz) ≤25dB HL;
• Tinnitus is a major problem faced by patients (except healthy volunteers);
• tinnitus course \> for 3 months;
• Healthy, no history of other ear diseases, no history of hearing impairment;
• There are no other medical, psychological or social problems that need urgent treatment, and no other problems that interfere with tinnitus-related treatment;
• Voluntary tinnitus treatment, and have enough time to cooperate with treatment.

You may not qualify if:

• Pulsatile tinnitus;
• Acute tinnitus;
• Tinnitus is associated with severe hearing loss;
• Tinnitus accompanied by vertigo;
• Tinnitus accompanied by headache;
• Tinnitus is accompanied by somatic symptoms, such as neck pain and temporomandibular joint disorder;
• Post-traumatic tinnitus;
• Tinnitus is associated with serious psychiatric complications;

Sponsors & Collaborators

• Eye & ENT Hospital of Fudan University: lead

MeSH Terms

Conditions

Tinnitus

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2020
• First Posted: June 26, 2020
• Study Start: July 1, 2020
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2023
• Last Updated: July 7, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share