This clinical study is a prospective, multicenter, randomized, controlled, double-blind clinical study. Sun Yat Sen Memorial Hospital of Sun Yat sen University was the central unit, and Nanjing First Hospital, Sun Yat Sen people's Hospital, Guanfzhou Panyu central Hospital and Zhuhai integrated traditional Chinese and Western medicine hospital were the cooperative units. In this study, 388 patients with chronic subjective tinnitus were recruited. In view of chronic subjective tinnitus, a common ear disease, the study gave the patients three months of treatment with transcutaneous vagus nerve stimulation paired with tailor-made notched music therapy or tailor-made notched music training alone. By comparing the changes of subjective scale scores related to tinnitus before and after treatment in patients receiving two different therapies, such as THI, VAS, BAI, BDI, PSQI, to evaluate the efficacy of the two therapies, so as to judge whether transcutaneous vagus nerve stimulation paired with tailor-made notched music therapy is better than tailor-made notched music training alone. In addition, the study will continue to follow up the patients after the treatment for one year to observe the difference in the long-term sustained efficacy of the two therapies. This clinical study will also evaluate the two therapies from the perspective of compliance and safety, and explore the factors that affect the efficacy of the two therapies.
Patients with tinnitus as the main complaint: the patients subjectively feel the sound in the ear or deep part of the head without internal or external sound stimulation, and therefore seek medical treatment
Chronic (≥ 6 months) and tonal tinnitus
Age 18-60
Tinnitus frequency is 125-8000 Hz
Patients with conductive deafness, history of middle ear surgery, pulsatile tinnitus caused by vascular distortion and tinnitus caused by Meniere disease
History of head trauma, central nervous system diseases, mental diseases and drug abuse
Parallel
Transcutaneous Vagus Nerve Stimulation Paired with Tailor-Made Notched Music Therapy
DeviceThe pulse frequency of vagus nerve stimulation is 25 Hz, the pulse width is 200 US, and the intensity is 1-10 mA. Tailor-made notched music is produced by filtering a frequency band of 1/2 octave width centered at the individual tinnitus frequency. When two sides of tinnitus frequencies are different, each side of music are filtered respectively, according to the different tinnitus frequency. When only have unilateral tinnitus or bilateral tinnitus in the same central frequency, both sides of music are filtered with the same tinnitus frequency. The tVNS and TMNM begin at the same time during treatment.
Tailor-made Notched Music Training
DeviceTailor-made notched music is produced by filtering a frequency band of 1/2 octave width centered at the individual tinnitus frequency. When two sides of tinnitus frequencies are different, each side of music are filtered respectively, according to the different tinnitus frequency. When only have unilateral tinnitus or bilateral tinnitus in the same central frequency, both sides of music are filtered with the same tinnitus frequency. At the beginning of TMNMT, 10 seconds sham vagus nerve stimulation is output, whose parameters are as same as experimental group.
Changes in Tinnitus Handicap Inventory (THI) scores for short-term efficacy assessment
Difference in the change of THI scores between two groups after 3-month treatment. The THI evaluates the severity of tinnitus in terms of emotion and function. The global scores of THI range from 0 (no disability) to 100 (serve disability).
Changes in scores of Visual Analog Scale (VAS) for short-term efficacy assessment
Difference in the change of VAS scores between two groups after 3-month treatment. The total VAS scores range from 0 (negligible) to 10 (too nosiy to tolerate), reflecting the loudness of tinnitus patients feel.
Changes in scores of Beck Anxiety Inventory (BAI) for short-term efficacy assessment
Difference in the change of BAI scores between two groups after 3-month treatment. The total BAI scores range from 0 (normal) to 63 (serve anxiety), reflecting the degree of anxiety.
Changes in scores of Beck Depression Inventory (BDI) for short-term efficacy assessment
Difference in the change of BDI scores between two groups after 3-month treatment. The total BDI scores range from 0 (normal) to 63 (serve depression), reflecting the degree of depression.
Changes in scores of Pittsburgh sleep quality index (PSQI) for short-term efficacy assessment
Difference in the change of PSQI scores between two groups after 3-month treatment. The total PSQI scores range from 0 (sleep well) to 21 (quite poor sleep), reflecting the sleep quality.
Incidence of treatment-related adverse events
Treatment related adverse events in two groups include: auditory system related adverse reactions caused by treatment, such as auricle burn, earache, hearing loss, tinnitus aggravation, and head injury Dizziness, headache, palpitation, vomiting and other non auditory system related adverse reactions. Incidence of adverse events = number of treatment-related adverse events during treatment / total number of participants in treatment.
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Lead sponsor
The First Affiliated Hospital with Nanjing Medical University
Collaborator
Zhongshan People's Hospital, Guangdong, China
Collaborator
Affiliated Zhuhai Hospital of Southern Medical University
Collaborator
Guangzhou Panyu Central Hospital
Collaborator
Shenshan Medical Center, Memorial Hospital of Sun Yat-sen University
Collaborator
Eighth Affiliated Hospital, Sun Yat-sen University
Collaborator
Second Affiliated Hospital of Guangzhou Medical University
Collaborator
Southern Medical University, China
Collaborator
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