Tinnitus, SubjectiveNCT04026932
The Clinical Effects of Modified TRS Treatment
A study testing Listening to unmodified music and Listening to modified tinnitus relieving sound in people with Tinnitus, Subjective, run by Eye & ENT Hospital of Fudan University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Tinnitus, Subjective
- What is being tested?
- Listening to unmodified music and Listening to modified tinnitus relieving sound
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteChina
- Study dates
- Aug 2019to Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University, Shanghai, China
Shanghai, Shanghai Municipality, 200031
Huawei Li, Phd &MD, hwli@shmu.edu.cn
Dongmei Tang, MD, tang.dongm@163.com
About this study
Official title: 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.
- Conditions
- Tinnitus, Subjective
- Being tested
- Listening to unmodified music, Listening to modified tinnitus relieving sound
- Keywords
- subjective tinnitus, tinnitus relieving sound, clinical effects
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Listening to unmodified musicOther
Listening to unmodified music for at least 2 hours a day
Listening to modified tinnitus relieving soundOther
Listening to modified tinnitus relieving sound for at least 2 hours a day
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Listening to modified tinnitus relieving sound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months from baseline
Secondary outcomes (12)
Athens Insomnia Scale (AIS)
AIS grades three categories of sleep disorder: no insomnia scoring below 4, suspicious (4-6), insomnia (7-24)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2019
- Study startAug 2019 (estimated)
- Primary completionAug 2021 (estimated)
- Study completionFeb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Tinnitus, SubjectiveStudies of the same condition, open and under way.
- More trials run by Eye & ENT Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eye & ENT Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huawei Li, Study chair, Eye & ENT Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04026932
- Sponsor's protocol ID
- Tinnitus sound therapy RCT
- Status last verified
- Jul 2019
- First submitted
- 11 Jul 2019
- Last updated
- 19 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23948178De 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.
PubMed 21502503Tunkel 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.
PubMed 25273878Cima 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.
PubMed 22633033Newman 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.
PubMed 8630207Tang 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.
PubMed 37268971
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Effects of Modified Tinnitus Relieving Sound Treatment
- ClinicalTrials.gov ID
- NCT04026932
- Acronym / sponsor ID
- Tinnitus sound therapy RCT
- Conditions
- Tinnitus, Subjective
- Keywords
- subjective tinnitus, tinnitus relieving sound, clinical effects
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- Aug 2019 (estimated)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 19 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unmodified music group | Placebo comparator | Other: Listening to unmodified music34 participants in Group 1 will listen to the music without any modification for at least two hours a day in total. |
| Modified tinnitus relieving sound group | Experimental | Other: Listening to modified tinnitus relieving sound34 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (6 listed)
- 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；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Listening to unmodified musicListening to unmodified music for at least 2 hours a day | Other | Unmodified music group |
| Listening to modified tinnitus relieving soundListening to modified tinnitus relieving sound for at least 2 hours a day | Other | Modified tinnitus relieving sound group |
Primary outcome
Tinnitus Handicapped Inventory (THI)
Time frame: 1 months from baseline
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.
Tinnitus Handicapped Inventory (THI)
Time frame: 3 months from baseline
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.
Tinnitus Handicapped Inventory (THI)
Time frame: 9 months from baseline
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.
Tinnitus Handicapped Inventory (THI)
Time frame: 12 months from baseline
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.
Hospital Anxiety and Distress Scale (HADS)
Time frame: 1 months from baseline
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).
Hospital Anxiety and Distress Scale (HADS)
Time frame: 3 months from baseline
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).
Hospital Anxiety and Distress Scale (HADS)
Time frame: 9 months from baseline
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).
Hospital Anxiety and Distress Scale (HADS)
Time frame: 12 months from baseline
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).
Visual Analogue Scale (VAS) for tinnitus
Time frame: 1 months from baseline
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.
Visual Analogue Scale (VAS) for tinnitus
Time frame: 3 months from baseline
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.
Visual Analogue Scale (VAS) for tinnitus
Time frame: 9 months from baseline
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.
Visual Analogue Scale (VAS) for tinnitus
Time frame: 12 months from baseline
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 secondary outcomes
Athens Insomnia Scale (AIS)
Time frame: 1 months from baseline
Athens Insomnia Scale (AIS)
Time frame: 3 months from baseline
Athens Insomnia Scale (AIS)
Time frame: 9 months from baseline
Athens Insomnia Scale (AIS)
Time frame: 12 months from baseline
tinnitus loudness matched by sensation level (LM, SL)
Time frame: 1 months from baseline
tinnitus loudness matched by sensation level (LM, SL)
Time frame: 3 months from baseline
tinnitus loudness matched by sensation level (LM, SL)
Time frame: 9 months from baseline
tinnitus loudness matched by sensation level (LM, SL)
Time frame: 12 months from baseline
minimum masking level (MML)
Time frame: 1 months from baseline
minimum masking level (MML)
Time frame: 3 months from baseline
minimum masking level (MML)
Time frame: 9 months from baseline
minimum masking level (MML)
Time frame: 12 months from baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2019.
- Background: PubMed 23948178Langguth 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.
- Background: PubMed 21502503De 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.
- Background: PubMed 25273878Tunkel 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.
- Background: PubMed 22633033Cima 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.
- Background: PubMed 8630207Newman 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.
- Derived from this study: PubMed 37268971Tang 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.
- Individual participant dataSharing planned: No
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COMPARISON OF MANUAL THERAPY, TINNITUS RETRAINING THERAPY
Somatosensory Tinnitus, Subjektif tınnitus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huawei Li study chair
Eye & ENT Hospital of Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Listening to unmodified music and Listening to modified tinnitus relieving sound in people with Tinnitus, Subjective, run by Eye & ENT Hospital of Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dongmei Tang (+86-13023299189, tang.dongm@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tinnitus Handicapped Inventory (THI) (time frame: 1 months from baseline). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04026932, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2019.