Clinical trial NCT04026932: The Clinical Effects of Modified TRS Treatment
Official title: The Clinical Effects of Modified Tinnitus Relieving Sound Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tinnitus, Subjective
Keywords: subjective tinnitus
tinnitus relieving sound
clinical effects
Lead sponsor: Eye & ENT Hospital of Fudan University
Sponsor class: OTHER
First posted: 2019-07-19
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Tinnitus Handicapped Inventory (THI)
timeFrame: 1 months from baseline
measure: Tinnitus Handicapped Inventory (THI)
timeFrame: 3 months from baseline
measure: Tinnitus Handicapped Inventory (THI)
timeFrame: 9 months from baseline
measure: Tinnitus Handicapped Inventory (THI)
timeFrame: 12 months from baseline
measure: Hospital Anxiety and Distress Scale (HADS)
timeFrame: 1 months from baseline
measure: Hospital Anxiety and Distress Scale (HADS)
timeFrame: 3 months from baseline
measure: Hospital Anxiety and Distress Scale (HADS)
timeFrame: 9 months from baseline
measure: Hospital Anxiety and Distress Scale (HADS)
timeFrame: 12 months from baseline
measure: Visual Analogue Scale (VAS) for tinnitus
timeFrame: 1 months from baseline
measure: Visual Analogue Scale (VAS) for tinnitus
timeFrame: 3 months from baseline
measure: Visual Analogue Scale (VAS) for tinnitus
timeFrame: 9 months from baseline
measure: Visual Analogue Scale (VAS) for tinnitus
timeFrame: 12 months from baseline
Secondary outcomes:
measure: Athens Insomnia Scale (AIS)
timeFrame: 1 months from baseline
measure: Athens Insomnia Scale (AIS)
timeFrame: 3 months from baseline
measure: Athens Insomnia Scale (AIS)
timeFrame: 9 months from baseline
measure: Athens Insomnia Scale (AIS)
timeFrame: 12 months from baseline
measure: tinnitus loudness matched by sensation level (LM, SL)
timeFrame: 1 months from baseline
measure: tinnitus loudness matched by sensation level (LM, SL)
timeFrame: 3 months from baseline
measure: tinnitus loudness matched by sensation level (LM, SL)
timeFrame: 9 months from baseline
measure: tinnitus loudness matched by sensation level (LM, SL)
timeFrame: 12 months from baseline
measure: minimum masking level (MML)
timeFrame: 1 months from baseline
measure: minimum masking level (MML)
timeFrame: 3 months from baseline
measure: minimum masking level (MML)
timeFrame: 9 months from baseline
measure: minimum masking level (MML)
timeFrame: 12 months from baseline
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University, Shanghai, China
state: Shanghai
Study officials:
affiliation: Eye and ENT Hospital of Fudan University
name: Huawei Li
role: STUDY_CHAIR
References:
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.
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.
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.
citation: 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.
citation: 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.