The Clinical Effects of Modified TRS Treatment

NCT04026932 | Unknown DMC

• 1 other identifier: Tinnitus sound therapy RCT
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tinnitus, Subjective

Keywords

subjective tinnitus; tinnitus relieving sound; clinical effects

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (12)

• Athens Insomnia Scale (AIS)

  1 months from baseline

• Athens Insomnia Scale (AIS)

  3 months from baseline

• Athens Insomnia Scale (AIS)

  9 months from baseline

• Athens Insomnia Scale (AIS)

  12 months from baseline

• tinnitus loudness matched by sensation level (LM, SL)

  1 months from baseline

Study Arms (2)

Unmodified music group

PLACEBO COMPARATOR

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

Modified tinnitus relieving sound group

EXPERIMENTAL

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

Interventions

Listening to unmodified music OTHER

Listening to unmodified music for at least 2 hours a day

Unmodified music group

Listening to modified tinnitus relieving sound OTHER

Listening to modified tinnitus relieving sound for at least 2 hours a day

Modified tinnitus relieving sound group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged between 18 to 80 years old;
• Diagnosed with subjective tinnitus;
• Chronic tinnitus: tinnitus course ≥3 months;
• Be able to understand and communicate with Mandarin；
• The average pure tone threshold (0.5, 1, 2kHz) ≤ 55dB HL of the worse ear;
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Eye & ENT Hospital of Fudan University: lead

Study Sites (1)

Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University, Shanghai, China

Shanghai, Shanghai Municipality, 200031, China

Location

Related Publications (6)

• 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.

  PMID: 23948178 BACKGROUND

• 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.

  PMID: 21502503 BACKGROUND

• 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.

  PMID: 25273878 BACKGROUND

• 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.

  PMID: 22633033 BACKGROUND

• 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.

  PMID: 8630207 BACKGROUND

• Tang D, Wang J, Yu X, Yu H. The clinical effects of modified tinnitus relieving sound (MTRS) for chronic tinnitus: protocol for a randomized controlled trial. Trials. 2023 Jun 2;24(1):372. doi: 10.1186/s13063-023-07389-8.

  PMID: 37268971 DERIVED

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

• Huawei Li

  Eye and ENT Hospital of Fudan University

  STUDY CHAIR

Central Study Contacts

Dongmei Tang

CONTACT

+86-13023299189; tang.dongm@163.com

Huiqian Yu

CONTACT

+86-13636423139; yhq925@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: SPONSOR

Study Record Dates

• First Submitted: July 11, 2019
• First Posted: July 19, 2019
• Study Start: August 1, 2019
• Primary Completion: August 1, 2021
• Study Completion: February 1, 2022
• Last Updated: July 19, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)