The Clinical Effects of Modified Tinnitus Relieving Sound Treatment
The Clinical Effects of Modified TRS Treatment
Sponsors
Source
Eye & ENT Hospital of Fudan University
Oversight Info
Has Dmc
Yes
Is Fda Regulated Drug
No
Is Fda Regulated Device
No
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.
Overall Status
Not yet recruiting
Start Date
2019-08-01
Completion Date
2022-02-01
Primary Completion Date
2021-08-01
Phase
N/A
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
Tinnitus Handicapped Inventory (THI) |
1 months from baseline |
|
Tinnitus Handicapped Inventory (THI) |
3 months from baseline |
|
Tinnitus Handicapped Inventory (THI) |
9 months from baseline |
|
Tinnitus Handicapped Inventory (THI) |
12 months from baseline |
|
Hospital Anxiety and Distress Scale (HADS) |
1 months from baseline |
|
Hospital Anxiety and Distress Scale (HADS) |
3 months from baseline |
|
Hospital Anxiety and Distress Scale (HADS) |
9 months from baseline |
|
Hospital Anxiety and Distress Scale (HADS) |
12 months from baseline |
|
Visual Analogue Scale (VAS) for tinnitus |
1 months from baseline |
|
Visual Analogue Scale (VAS) for tinnitus |
3 months from baseline |
|
Visual Analogue Scale (VAS) for tinnitus |
9 months from baseline |
|
Visual Analogue Scale (VAS) for tinnitus |
12 months from baseline |
Secondary Outcome
Measure |
Time Frame |
|
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 |
|
tinnitus loudness matched by sensation level (LM, SL) |
3 months from baseline |
|
tinnitus loudness matched by sensation level (LM, SL) |
9 months from baseline |
|
tinnitus loudness matched by sensation level (LM, SL) |
12 months from baseline |
|
minimum masking level (MML) |
1 months from baseline |
|
minimum masking level (MML) |
3 months from baseline |
|
minimum masking level (MML) |
9 months from baseline |
|
minimum masking level (MML) |
12 months from baseline |
Enrollment
68
Condition
Intervention
Intervention Type
Other
Intervention Name
Description
Listening to unmodified music for at least 2 hours a day
Arm Group Label
Unmodified music group
Intervention Type
Other
Intervention Name
Description
Listening to modified tinnitus relieving sound for at least 2 hours a day
Arm Group Label
Modified tinnitus relieving sound group
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.
Gender
All
Minimum Age
18 Years
Maximum Age
80 Years
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Huawei Li |
Study Chair |
Eye and ENT Hospital of Fudan University |
Overall Contact
Location
Facility |
Status |
Contact |
Investigator |
|
Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University, Shanghai, China Shanghai Shanghai 200031 China |
Not yet recruiting |
Last Name: Huawei Li, Phd & MD Role: Principal Investigator Last Name: Dongmei Tang, Phd & MD Role: Principal Investigator Last Name: Huiqian Yu, MD Role: Principal Investigator |
Location Countries
Country
China
Verification Date
2019-07-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor
Keywords
Has Expanded Access
No
Condition Browse
Number Of Arms
2
Arm Group
Arm Group Label
Unmodified music group
Arm Group Type
Placebo Comparator
Description
34 participants in Group 1 will listen to the music without any modification for at least two hours a day in total.
Arm Group Label
Modified tinnitus relieving sound group
Arm Group Type
Experimental
Description
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.
Firstreceived Results Date
N/A
Overall Contact Backup
Reference
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.
PMID
23948178
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.
PMID
21502503
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.
PMID
25273878
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.
PMID
22633033
Citation
Newman CW, Jacobson GP, Spitzer JB. Development of the Tinnitus Handicap Inventory. Arch Otolaryngol Head Neck Surg. 1996 Feb;122(2):143-8.
PMID
8630207
Patient Data
Sharing Ipd
No
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)
Study First Submitted
July 11, 2019
Study First Submitted Qc
July 18, 2019
Study First Posted
July 19, 2019
Last Update Submitted
July 18, 2019
Last Update Submitted Qc
July 18, 2019
Last Update Posted
July 19, 2019
ClinicalTrials.gov processed this data on December 13, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.