The Clinical Effects of Modified TRS Treatment

The Clinical Effects of Modified Tinnitus Relieving Sound Treatment

Objective Tinnitus is one of the most common acoustic disorders by affecting 5-43% people around the world, and tinnitus is harmful to social and individuals, inducing to annoyance, irritability, anxiety, depression, insomnia and concentration difficulties. Many efforts have been made to help tinnitus suffers, however, the curative means are still in absence. This study aims to introduce a novel sound therapy for tinnitus and to evaluate the efficacy of modified tinnitus relieving sound treatment in comparison with unmodified music which served as a control.

Methods and analysis A randomized, triple-blinded, controlled, clinical trial will be carried out. 68 patients with subjective tinnitus will be recruited and randomized into two groups in 1:1 ratio. The primary outcomes will be Tinnitus Handicapped Inventory (THI), Hospital Anxiety and Distress Scale (HADS), and visual analogue scale (VAS) for tinnitus; the secondary outcome measures will be Athens Insomnia Scale (AIS), tinnitus loudness matched by sensation level (LM, SL), and minimum masking level (MML). Assessment will be performed at baseline and at 1, 3, 9, and 12 months post-randomization. The sound stimulus will be persistent until 9 months after randomization, and be interdictory in the last three months.

Study Overview

• Status: Unknown
• Conditions: Tinnitus, Subjective
• Intervention / Treatment: Other: Listening to unmodified music; Other: Listening to modified tinnitus relieving sound

• Study Type: Interventional
• Enrollment (Anticipated): 68
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dongmei Tang; Phone Number: +86-13023299189; Email: tang.dongm@163.com
• Study Contact Backup: Name: Huiqian Yu; Phone Number: +86-13636423139; Email: yhq925@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200031
      • Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University, Shanghai, China
      • Contact: Huawei Li, Phd &MD; Email: hwli@shmu.edu.cn
      • Contact: Dongmei Tang, MD; Email: tang.dongm@163.com
      • Principal Investigator: Huawei Li, Phd & MD
      • Principal Investigator: Dongmei Tang, Phd & MD
      • Principal Investigator: Huiqian Yu, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Adults aged between 18 to 80 years old;
2. Diagnosed with subjective tinnitus;
3. Chronic tinnitus: tinnitus course ≥3 months;
4. Be able to understand and communicate with Mandarin；
5. The average pure tone threshold (0.5, 1, 2kHz) ≤ 55dB HL of the worse ear;
6. Subjects are able to understand the purpose of the study, volunteer to participate and cooperate with the instructors to complete the experiment, and be willing to sign the informed consent.

Exclusion Criteria:

1. Pulsatile tinnitus and objective tinnitus；
2. Having significant health issues that affect or prevent participation or continue with the follow-up;
3. Diseases requiring other medical intervention first (eg, infections, tumors, otosclerosis, Meniere's disease, the acute stage of sudden sensorineural hearing loss);
4. People with severe hyperacusis, severe anxiety, depression and other psychiatric disorders；
5. Currently participating in other research projects that may affect tinnitus；
6. Subjects who are not considered suitable for this clinical trial by the researchers.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Unmodified music group; 34 participants in Group 1 will listen to the music without any modification for at least two hours a day in total.	Other: Listening to unmodified music; Listening to unmodified music for at least 2 hours a day
Experimental: Modified tinnitus relieving sound group; 34 participants in Group 2 will listen to the music modified according to the matched dominant tinnitus pitch for at least two hours a day in total.	Other: Listening to modified tinnitus relieving sound; Listening to modified tinnitus relieving sound for at least 2 hours a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tinnitus Handicapped Inventory (THI)	THI is a self-assessment inventory including 25 items with grades four categories of tinnitus severity: slight corresponding to a score 0-16, mild (18-36), moderate (38-56), severe (58-100). The higher the score the more severe the tinnitus.	1 months from baseline
Tinnitus Handicapped Inventory (THI)	THI is a self-assessment inventory including 25 items with grades four categories of tinnitus severity: slight corresponding to a score 0-16, mild (18-36), moderate (38-56), severe (58-100). The higher the score the more severe the tinnitus.	3 months from baseline
Tinnitus Handicapped Inventory (THI)	THI is a self-assessment inventory including 25 items with grades four categories of tinnitus severity: slight corresponding to a score 0-16, mild (18-36), moderate (38-56), severe (58-100). The higher the score the more severe the tinnitus.	9 months from baseline
Tinnitus Handicapped Inventory (THI)	THI is a self-assessment inventory including 25 items with grades four categories of tinnitus severity: slight corresponding to a score 0-16, mild (18-36), moderate (38-56), severe (58-100). The higher the score the more severe the tinnitus.	12 months from baseline
Hospital Anxiety and Distress Scale (HADS)	HADS includes two subscales for anxiety and depression, each with respective 7 items, and the grades are valued by scoring: negative (0-7), positive (8-21).	1 months from baseline
Hospital Anxiety and Distress Scale (HADS)	HADS includes two subscales for anxiety and depression, each with respective 7 items, and the grades are valued by scoring: negative (0-7), positive (8-21).	3 months from baseline
Hospital Anxiety and Distress Scale (HADS)	HADS includes two subscales for anxiety and depression, each with respective 7 items, and the grades are valued by scoring: negative (0-7), positive (8-21).	9 months from baseline
Hospital Anxiety and Distress Scale (HADS)	HADS includes two subscales for anxiety and depression, each with respective 7 items, and the grades are valued by scoring: negative (0-7), positive (8-21).	12 months from baseline
Visual Analogue Scale (VAS) for tinnitus	Visual Analogue Scale (VAS) for tinnitus is a universal psychometric scale evaluating subjective tinnintus. A total score is 10, from 0 to 10. The higher the score, the more severe the symptom.	1 months from baseline
Visual Analogue Scale (VAS) for tinnitus	Visual Analogue Scale (VAS) for tinnitus is a universal psychometric scale evaluating subjective tinnintus. A total score is 10, from 0 to 10. The higher the score, the more severe the symptom.	3 months from baseline
Visual Analogue Scale (VAS) for tinnitus	Visual Analogue Scale (VAS) for tinnitus is a universal psychometric scale evaluating subjective tinnintus. A total score is 10, from 0 to 10. The higher the score, the more severe the symptom.	9 months from baseline
Visual Analogue Scale (VAS) for tinnitus	Visual Analogue Scale (VAS) for tinnitus is a universal psychometric scale evaluating subjective tinnintus. A total score is 10, from 0 to 10. The higher the score, the more severe the symptom.	12 months from baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Athens Insomnia Scale (AIS)	AIS grades three categories of sleep disorder: no insomnia scoring below 4, suspicious (4-6), insomnia (7-24)	1 months from baseline
Athens Insomnia Scale (AIS)	AIS grades three categories of sleep disorder: no insomnia scoring below 4, suspicious (4-6), insomnia (7-24)	3 months from baseline
Athens Insomnia Scale (AIS)	AIS grades three categories of sleep disorder: no insomnia scoring below 4, suspicious (4-6), insomnia (7-24)	9 months from baseline
Athens Insomnia Scale (AIS)	AIS grades three categories of sleep disorder: no insomnia scoring below 4, suspicious (4-6), insomnia (7-24)	12 months from baseline
tinnitus loudness matched by sensation level (LM, SL)	The loudness of tinnitus is reflected in sensation level (dB SL). Sensation level is defined as the loudness value above hearing threshold at the pitch of tinnitus.	1 months from baseline
tinnitus loudness matched by sensation level (LM, SL)	The loudness of tinnitus is reflected in sensation level (dB SL). Sensation level is defined as the loudness value above hearing threshold at the pitch of tinnitus.	3 months from baseline
tinnitus loudness matched by sensation level (LM, SL)	The loudness of tinnitus is reflected in sensation level (dB SL). Sensation level is defined as the loudness value above hearing threshold at the pitch of tinnitus.	9 months from baseline
tinnitus loudness matched by sensation level (LM, SL)	The loudness of tinnitus is reflected in sensation level (dB SL). Sensation level is defined as the loudness value above hearing threshold at the pitch of tinnitus.	12 months from baseline
minimum masking level (MML)	MML test is presented bilaterally, the noise is raised until tinnitus is just covered in both ears. The higher the value, the more severe the tinnitus.	1 months from baseline
minimum masking level (MML)	MML test is presented bilaterally, the noise is raised until tinnitus is just covered in both ears. The higher the value, the more severe the tinnitus.	3 months from baseline
minimum masking level (MML)	MML test is presented bilaterally, the noise is raised until tinnitus is just covered in both ears. The higher the value, the more severe the tinnitus.	9 months from baseline
minimum masking level (MML)	MML test is presented bilaterally, the noise is raised until tinnitus is just covered in both ears. The higher the value, the more severe the tinnitus.	12 months from baseline

Collaborators and Investigators

• Sponsor: Eye & ENT Hospital of Fudan University
• Investigators: Study Chair: Huawei Li, Eye and ENT Hospital of Fudan University

Publications and helpful links

General Publications

• 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(9830):1951-9. doi: 10.1016/S0140-6736(12)60469-3.
• 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. Otolaryngol Head Neck Surg. 2014 Oct;151(2 Suppl):S1-S40. doi: 10.1177/0194599814545325.
• De Ridder D, Elgoyhen AB, Romo R, Langguth B. Phantom percepts: tinnitus and pain as persisting aversive memory networks. Proc Natl Acad Sci U S A. 2011 May 17;108(20):8075-80. doi: 10.1073/pnas.1018466108. Epub 2011 Apr 18.
• Newman CW, Jacobson GP, Spitzer JB. Development of the Tinnitus Handicap Inventory. Arch Otolaryngol Head Neck Surg. 1996 Feb;122(2):143-8. doi: 10.1001/archotol.1996.01890140029007.
• Langguth B, Kreuzer PM, Kleinjung T, De Ridder D. Tinnitus: causes and clinical management. Lancet Neurol. 2013 Sep;12(9):920-930. doi: 10.1016/S1474-4422(13)70160-1.

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2019
• Primary Completion (Anticipated): August 1, 2021
• Study Completion (Anticipated): February 1, 2022

Study Registration Dates

• First Submitted: July 11, 2019
• First Submitted That Met QC Criteria: July 18, 2019
• First Posted (Actual): July 19, 2019

Study Record Updates

• Last Update Posted (Actual): July 19, 2019
• Last Update Submitted That Met QC Criteria: July 18, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: subjective tinnitus; tinnitus relieving sound; clinical effects
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Tinnitus
• Other Study ID Numbers: Tinnitus sound therapy RCT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No