NCT03764826

Study on the Effect of Sound Therapy on Chronic Primary Tinnitus

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Beijing Friendship Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tinnitus

Interventions

Type	Name	Description
DEVICE	CAABT	The sound generators with CAABT will be used 15 min each session, three times a day
DEVICE	TMT	The sound generators with TMT will be used 15 min each session, three times a day

Timeline

• Start date: 2018-12-01
• Primary completion: 2019-06-08
• Completion: 2019-12-08
• First posted: 2018-12-05
• Last updated: 2018-12-11

Locations

1 site across 1 country: China