Study on the Effect of Sound Therapy on Chronic Primary Tinnitus

NCT03764826 | Unknown

• 1 other identifier: 2018-P2-182-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Tinnitus

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (2)

CAABT

EXPERIMENTAL

CAABT(Cochleural Alternating Acoustic Beam Therapy) is 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.

Device: CAABT

TMT

ACTIVE COMPARATOR

TMT(tinnitus masking therapy) is a traditional tinnitus intervention. The masking sound is mainly white noise, and the intensity just covers tinnitus.

Device: TMT

Interventions

CAABT DEVICE

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

CAABT

TMT DEVICE

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

TMT

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Friendship Hospital: lead

Study Sites (1)

Beijing Friendship Hospital,Capital Medical University

Beijing, Beijing Municipality, 100031, China

RECRUITING

Related Publications (2)

• 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.

  PMID: 25274374 RESULT

• 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.

  PMID: 29655489 RESULT

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Shu-Sheng Gong, MD

  Beijing Friendship Hospital

  STUDY DIRECTOR

Central Study Contacts

Shu-Sheng Gong, MD

CONTACT

13911068366; 50228354@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director of Department of Otorhinolaryngology Head and Neck Surgery

Study Record Dates

• First Submitted: November 30, 2018
• First Posted: December 5, 2018
• Study Start: December 1, 2018
• Primary Completion: June 8, 2019
• Study Completion: December 8, 2019
• Last Updated: December 11, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data access requests will be reviewed by an external Independent Review Panel.
• Access Criteria: Data access requests will be reviewed by an external Independent Review Panel

Locations

CN (1)