Study on the Effect of Sound Therapy on Chronic Primary Tinnitus

Tinnitus Clinical Trial

Official title:

Study on the Effect of Sound Therapy on Chronic Primary Tinnitus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03764826
• Other study ID #: 2018-P2-182-01
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: December 8, 2019

Study information

• Verified date: December 2018
• Source: Beijing Friendship Hospital
• Contact: Shu-Sheng Gong, MD
• Phone: 13911068366
• Email: 50228354[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 8, 2019
• Est. primary completion date: June 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Tinnitus

Intervention

Device:
• CAABT
The sound generators with CAABT will be used 15 min each session, three times a day
• TMT
The sound generators with TMT will be used 15 min each session, three times a day

Locations

Country	Name	City	State
China	Beijing Friendship Hospital,Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Friendship Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View 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, Wagu — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tinnitus Handicap Inventory ( THI)	Change from Baseline in Tinnitus Subjective Measures at 2 months, 4 months, 6 months: Tinnitus Handicap Inventory scale.; Efficacy evaluation criteria: (1) cure: THI score was reduced to less than 16 points;(2) significant effect: THI score decreased by more than 17 points;(3) invalid: THI score value decreased < 17 points or even increased.Efficiency is the sum of cure and effect.	baseline, 2 months, 4 months, 6 months
Primary	Resting-state function magnetic resonance imaging(RS-fMRI) Regional homogeneity(ReHo) value	Change from Baseline in Tinnitus Subjective Measures at 6 months: RS-fMRI ReHo value	baseline, 6 months
Primary	Resting-state function magnetic resonance imaging(RS-fMRI) low-frequency wave amplitude (ALFF)	Change from Baseline in Tinnitus Subjective Measures at 6 months: RS-fMRI ALFF	baseline, 6 months
Primary	Visual Analogue Scale(VAS)	Change from Baseline in Tinnitus Subjective Measures at 2 months, 4 months, 6 months: Visual Analogue Scale(VAS).; The number 0 to 10 indicates the severity of symptoms, "0" means no symptoms, and "10" means the most severe	baseline, 2 months, 4 months, 6 months