The Clinical Effects of Modified TRS Treatment

Tinnitus, Subjective Clinical Trial

Official title:

The Clinical Effects of Modified Tinnitus Relieving Sound Treatment

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04026932
• Other study ID #: Tinnitus sound therapy RCT
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2019
• Est. completion date: February 2022

Study information

• Verified date: July 2019
• Source: Eye & ENT Hospital of Fudan University
• Contact: Dongmei Tang
• Phone: +86-13023299189
• Email: tang.dongm[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 68
• Est. completion date: February 2022
• Est. primary completion date: August 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Tinnitus
• Tinnitus, Subjective

Intervention

Other:
• Listening to unmodified music
Listening to unmodified music for at least 2 hours a day
• Listening to modified tinnitus relieving sound
Listening to modified tinnitus relieving sound for at least 2 hours a day

Locations

Country	Name	City	State
China	Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University, Shanghai, China	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Eye & ENT Hospital of Fudan University

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. Review. — View Citation

Newman CW, Jacobson GP, Spitzer JB. Development of the Tinnitus Handicap Inventory. Arch Otolaryngol Head Neck Surg. 1996 Feb;122(2):143-8. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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