Clinical trial NCT03764826: Study on the Effect of Sound Therapy on Chronic Primary Tinnitus
Official title: Study on the Effect of Sound Therapy on Chronic Primary Tinnitus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tinnitus
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2018-12-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to compare the effect of Cochleural Alternating Acoustic Beam Therapy(CAABT) and tinnitus masking therapy(TMT) on chronic primary tinnitus.Half of participants will receive CAABT, while the other half will receive TMT.

Detailed description: The patients with tinnitus will be collected with medical history, ear examination ,auditory function test and questionnaire survey.100 cases of chronic primary tinnitus will be selected as the research object.This study will be developed in the form of a blind randomized clinical trial.The study subjects will be divided into 2 groups by randomized method, with 50 cases in each group. Psychological acoustic test, Resting-state function magnetic resonance imaging（RS-fMRI) will be conducted.For 6 months, the patients will be treated with Cochleural Alternating Acoustic Beam Therapy（CAABT）and tinnitus masking therapy（TMT） respectively, followed by questionnaire survey, psychological acoustics test and RS-fMRI. The THI,VAS score, RS-fMRI ReHo value and low-frequency wave amplitude (ALFF) before and after the treatment will be compared. For those cases with poor results, the exchanged treatment will be performed for 6 months, followed by questionnaire survey, psychoacoustic test, RS-fMRI, and comparison of THI, VAS score, ReHo value and ALFF before and after treatment.All cases will be followed up for 1 year, and questionnaire survey will be conducted again.

Eligibility criteria: Inclusion Criteria:

* Ages between 18-75 years
* Tinnitus undergone for more than 6 months
* Continuous attack, single tone dominated, annoying tinnitus
* Able to cooperate with auditory function test and psychoacoustic test
* The main tinnitus frequency is from 125Hz to 8000Hz
* Willing to use the equipment daily during the test
* Willing and able to follow up regularly
* Ability to read and write Chinese, able to understand and complete questionnaires

Exclusion Criteria:

* Secondary tinnitus
* Pure tone audiometry shows conduction deafness or mixed deafness
* Tinnitus main frequency threshold \>60dB
* Receiving treatment for other tinnitus
* MRI contraindications
* Feeling uncomfortable with the treatment equipment or not being accepted

Primary outcomes:
measure: Tinnitus Handicap Inventory ( THI)
timeFrame: baseline, 2 months, 4 months, 6 months
measure: Resting-state function magnetic resonance imaging(RS-fMRI) Regional homogeneity(ReHo) value
timeFrame: baseline, 6 months
measure: Resting-state function magnetic resonance imaging(RS-fMRI) low-frequency wave amplitude (ALFF)
timeFrame: baseline, 6 months
measure: Visual Analogue Scale(VAS)
timeFrame: baseline, 2 months, 4 months, 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital,Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Friendship Hospital
name: Shu-Sheng Gong, MD
role: STUDY_DIRECTOR
References:
citation: Tunkel DE, Bauer CA, Sun GH, Rosenfeld RM, Chandrasekhar SS, Cunningham ER Jr, Archer SM, Blakley BW, Carter JM, Granieri EC, Henry JA, Hollingsworth D, Khan FA, Mitchell S, Monfared A, Newman CW, Omole FS, Phillips CD, Robinson SK, Taw MB, Tyler RS, Waguespack R, Whamond EJ. Clinical practice guideline: tinnitus executive summary. Otolaryngol Head Neck Surg. 2014 Oct;151(4):533-41. doi: 10.1177/0194599814547475.
citation: Liu C, Lv H, Jiang T, Xie J, He L, Wang G, Liu J, Wang Z, Gong S. The Cochleural Alternating Acoustic Beam Therapy (CAABT): A pre-clinical trial. Am J Otolaryngol. 2018 Jul-Aug;39(4):401-409. doi: 10.1016/j.amjoto.2018.04.002. Epub 2018 Apr 3.