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

Tinnitus, Subjective Clinical Trial

Official title:

Cochleural Alternating Acoustic Beam Therapy Versus Masking Intervention for Tinnitus: A Randomised Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02774122
• Other study ID #: 961619
• Status: Active, not recruiting
• Phase: N/A
• First received: May 8, 2016
• Last updated: January 20, 2018
• Start date: April 2016
• Est. completion date: October 2018

Study information

• Verified date: January 2018
• Source: Beijing Friendship Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: October 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Tinnitus
• Tinnitus, Subjective

Intervention

Device:
• 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 intervention was a standard monophone tinnitus masking therapy.

Locations

Country	Name	City	State
China	Otorhinolaryngology Head and Neck Surgery department	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Friendship Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

Cima RF, Maes IH, Joore MA, Scheyen DJ, El Refaie A, Baguley DM, Anteunis LJ, van Breukelen GJ, Vlaeyen JW. Specialised treatment based on cognitive behaviour therapy versus usual care for tinnitus: a randomised controlled trial. Lancet. 2012 May 26;379(9 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Tinnitus Subjective Measures at 12 weeks: pure tone audiometry		baseline and 12 weeks
Primary	Change from Baseline in Tinnitus Subjective Measures at 12 weeks: tinnitus loudness		baseline and 12 weeks
Primary	Change from Baseline in Tinnitus Subjective Measures at 12 weeks: minimize masking level		baseline and 12 weeks
Primary	Change from Baseline in Tinnitus Subjective Measures at 12 weeks: the Chinese version of Tinnitus Handicap Inventory scale		baseline and 12 weeks
Primary	Change from Baseline in Tinnitus Subjective Measures at 12 weeks: the Visual Analog Scale		baseline and 12 weeks
Secondary	Change from Baseline in Tinnitus Objective Measure at 12 weeks: functional magnetic resonance imaging (fMRI)		baseline and 12 weeks

External Links

•   Clinical Key links