Cochleural Alternating Acoustic Beam Therapy (CAABT) Versus Masking Intervention for Tinnitus

Not Applicable

• Conditions: Tinnitus, Subjective
• Interventions: Device: CAABT; Device: masking therapy

• Registration Number: NCT02774122
• Lead Sponsor: Beijing Friendship Hospital

Brief Summary

This study is to compare the effectiveness of CAABT and masking therapy in the management of subjective tinnitus in adults.Half of participants will receive CAABT, while the other half will receive masking therapy.

Detailed Description

Masking intervention was a standard monophone tinnitus masking therapy. It was usually a narrow-band noise matched with tinnitus frequency (Tf).

CAABT was an innovative tinnitus intervention which based on neural science and cochlear plastic research and aimed to reprogram the central auditory system to neutralize the discordant responses of the dysfunctioning cochlea via acoustic beaming stimuli.

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-05-08
• Study First Submitted QC: 2016-05-12
• Study First Posted: 2016-05-17
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-20
• Last Update Posted: 2018-01-23
• Primary Completion: 2018-08
• Study Completion: 2018-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Unilateral tinnitus
• Ages between 18-80 years
• Tinnitus undergone for more than 6 months
• Hearing loss of the tinnitus ear not affect communication
• The main tinnitus frequency is less than 8 KHz
• Primary tinnitus

Exclusion Criteria

• Secondary tinnitus
• Hyperacusis
• Patients were accepting any therapy about tinnitus
• Those who have serious mental illness
• Patients who can't fit the audiological examination and tinnitus tests
• Most of the hearing loss in the middle and severe hearing loss of the tinnitus ear
• Any MRI contraindications

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CAABT	CAABT	CAABT was an innovative tinnitus intervention which based on neural science and cochlear plastic research and aimed to reprogram the central auditory system to neutralize the discordant responses of the dysfunctioning cochlea via acoustic beaming stimuli.
masking therapy	masking therapy	Masking intervention was a standard monophone tinnitus masking therapy.

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Tinnitus Subjective Measures at 12 weeks: tinnitus loudness	baseline and 12 weeks
Change from Baseline in Tinnitus Subjective Measures at 12 weeks: minimize masking level	baseline and 12 weeks
Change from Baseline in Tinnitus Subjective Measures at 12 weeks: the Visual Analog Scale	baseline and 12 weeks
Change from Baseline in Tinnitus Subjective Measures at 12 weeks: pure tone audiometry	baseline and 12 weeks
Change from Baseline in Tinnitus Subjective Measures at 12 weeks: the Chinese version of Tinnitus Handicap Inventory scale	baseline and 12 weeks

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in Tinnitus Objective Measure at 12 weeks: functional magnetic resonance imaging (fMRI)	baseline and 12 weeks

Trial Locations

Locations (1)

Otorhinolaryngology Head and Neck Surgery department; 🇨🇳 Beijing, Beijing, China