Subjective TinnitusNCT06727175
A Multicenter Study of Noninvasive Neuromodulation Treatment for Subjective Tinnitus
An observational study of Subjective Tinnitus, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
The purpose of this study is to find out the scientific and effectiveness of non-invasive neuromodulation therapy for subjective tinnitus and further guide the clinical response to tinnitus problems. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subjective Tinnitus
- What is being tested?
- non-invasive neuromodulation therapy and before any intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 31 Jul 2024
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjective tinnitus patients and compliance with 6 months of noninvasive neuromodulation therapy, with complete two-assessment scale records.
Who may be able to join
- ≥18yrs,
- Diagnosed as subjective tinnitus,
- THI≥38,
- Chinese, can cooperate with all Chinese version evaluation,
- Right-handed,
- No major neurological disease or other
Who cannot join
- Hyperacustic,
- Incomplete case data
Trial locations and contacts
1 site in 1 country.
China1 site
Sun Yat-sen Memorial Hospital of Sun Yat-sen University, Guangzhou, Guangdong 510000
Guangzhou, Guangdong, 510000
About this study
Official title: A Multi-center Efficacy Study of Noninvasive Neuromodulation in the Treatment of Subjective Tinnitus
The purpose of this study is to find out the scientific and effectiveness of non-invasive neuromodulation therapy for subjective tinnitus and further guide the clinical response to tinnitus problems. This study collects the case data of subjective tinnitus patients who received non-invasive neuromodulation treatment for statistical analysis. The complete data included pure tone audiometry, tinnitus assessment, mood assessments, and sleep quality assessment. Paired T-tests are suppoesed to be conducted to analyze the clinical efficacy of non-invasive neuromodulation therapy for subjective tinnitus and its specific effect on improving mood and sleep.
Read the detailed description
The purpose of this study is to find out the scientific and effectiveness of non-invasive neuromodulation therapy for subjective tinnitus and further guide the clinical response to tinnitus problems. This study collects the case data of subjective tinnitus patients who received non-invasive neuromodulation treatment for statistical analysis. The complete data included pure tone audiometry, tinnitus assessment (tinnitus matching, Tinnitus Handicap Inventory, Tinnitus Function Index, Visual analog Scales), mood assessments (Hamilton Anxiety Scale, Hamilton Depression Scale), and sleep quality assessment (Pittsburgh Sleep Index Scale). Paired T-tests are suppoesed to be conducted to analyze the clinical efficacy of non-invasive neuromodulation therapy for subjective tinnitus and its specific effect on improving mood and sleep.
- Conditions
- Subjective Tinnitus
- Being tested
- non-invasive neuromodulation therapy, before any intervention
- Keywords
- non-invasive neuromodulation, Subjective tinnitus, clinical effect, sleep quality, anxiety, depression
- Medical subject headings
- Tinnitus, Sleep Initiation and Maintenance Disorders, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-invasive neuromodulation therapyBehavioural
Patients with subjective tinnitus were treated using non-invasive neuroregulation therapy. That is, to generate personalized, non-invasive acoustically stimulated neuroregulation regimens for six montns. Each participant was treated three times a day (morning, noon and bedtime) for 30 minutes each time.
before any interventionOther
before any intervention
| Study group | Role | What they receive |
|---|---|---|
| before non-invasive neuromodulation therapy | evaluation results before non-invasive neuroregulation therapy Receives: Other: before any intervention | |
| after non-invasive neuromodulation therapy | evaluation results after six-month non-invasive neuroregulation therapy Receives: Behavioral: non-invasive neuromodulation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
tinnitus loudness
Taking 1dB as the step, parrticipants were asked to select the signal sound intensity consistent with their subjective tinnitus loudness, and the tinnitus loudness matching was completed after repeated testing. The difference between the matched intensity and the pure tone hearing threshold at this frequency was recorded as tinnitus loudness (dB SL).
Measured: 0-7 days pre-therapy, 0-7 days post-therapy
tinnitus handicap inventory, THI
THI is divided into three sub-scales, namely functional, emotional and catastrophic. THI contains a total of 25 items, and each item is scored 4, 2 and 0 points according to \"yes\", \"sometimes\" and \"no\" respectively. After each item score was completed, the THI total score, THI functional total score (THI-F), THI affective total score (THI-E), and THI catastrophic total score (THI-C) were calculated for the specific patient. The severity of tinnitus was evaluated according to the total score: 1-16 points, grade 1 (slight); 18-36 points, grade 2 (mild); 38-56pointks, grade 3 (moderate); 58-76 points, level 4 (severe); Score 78-100, level 5 (catastrophic).
Measured: 0-7 days pre-therapy, 0-7 days post-therapy
tinnitus functional index, TFI
The scale contains 8 subscales. They are denoted as TFI-I (Intrusiveness) and TFI-SC (Sense of) control), TFI-C (Cognition), TFI-S (Sleep), TFI-A (Auditory), TFI-R (Relaxation), TFI-Q (Quality of life), TFI-E (Emotional) distress); A total of 25 items are included. Each item is worth 100 points. The average score of all items is recorded as the total TFI score. The higher the score, the higher the pain and severity of the subject\'s tinnitus.
Measured: 0-7 days pre-therapy, 0-7 days post-therapy
visual analogue scale, VAS
VAS was used to evaluate the impact of tinnitus on the daily life of patients with chronic subjective tinnitus. Scale 0-10. A score of 0 means that tinnitus has no impact on daily life, and a score of 10 means that tinnitus has an intolerable, fatal level of impact on daily life. VAS was used to evaluate subjective tinnitus loudness, annoyance, depression, and tinnitus control difficulty.
Measured: 0-7 days pre-therapy, 0-7 days post-therapy
Secondary outcomes (3)
Hamilton Anxiety Scale, HAMA
The scale contains 14 items, mainly involving two aspects of physical anxiety and mental anxiety. The scale is scored on a 0-4 scale on five scales: 0 for asymptomatic, 1 for mild, 2 for moderate, 3 for severe, and 4 for extremely severe.
Measured: 0-7 days pre-therapy, 0-7 days post-therapy
Hamilton depression scale, HAMD
The study uses a 24-item version. Each item is scored on a 0-4 scale on a 5-point scale: 0 for asymptomatic, 1 for mild, 2 for moderate, 3 for severe, and 4 for extremely severe.
Measured: 0-7 days pre-therapy, 0-7 days post-therapy
Pittsburgh sleep quality index, PSQI
The scale contains 24 items, which are divided into subjective sleep quality, sleep time, sleep latency, sleep efficiency, sleep disorders, sleep medication use and daily dysfunction, with a total of 7 components. Each component is rated 0-3 points. The total score ranges from 0 to 21. The higher the score, the worse the sleep quality in the past month. Among them, 0-5 points represent excellent sleep quality, 6-10 points represent good sleep quality, 11-15 points represent moderate sleep quality, 16-20 points indicate poor sleep quality, and 21 points indicate the worst sleep quality.
Measured: 0-7 days pre-therapy, 0-7 days post-therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start1 Jan 2018
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subjective TinnitusStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Haidi Yang, PhD, Study director, SunYatSunU2H
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06727175
- Sponsor's protocol ID
- SYSKY-2024-671-01
- Status last verified
- Dec 2024
- First submitted
- 6 Dec 2024
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Efficacy Study of Noninvasive Neuromodulation in the Treatment of Subjective Tinnitus
- ClinicalTrials.gov ID
- NCT06727175
- Acronym / sponsor ID
- SYSKY-2024-671-01
- Conditions
- Subjective Tinnitus
- Keywords
- non-invasive neuromodulation, Subjective tinnitus, clinical effect, sleep quality, anxiety, depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 10 Dec 2024 (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.
The purpose of this study is to find out the scientific and effectiveness of non-invasive neuromodulation therapy for subjective tinnitus and further guide the clinical response to tinnitus problems. This study collects the case data of subjective tinnitus patients who received non-invasive neuromodulation treatment for statistical analysis. The complete data included pure tone audiometry, tinnitus assessment, mood assessments, and sleep quality assessment. Paired T-tests are suppoesed to be conducted to analyze the clinical efficacy of non-invasive neuromodulation therapy for subjective tinnitus and its specific effect on improving mood and sleep.
Detailed description
The purpose of this study is to find out the scientific and effectiveness of non-invasive neuromodulation therapy for subjective tinnitus and further guide the clinical response to tinnitus problems. This study collects the case data of subjective tinnitus patients who received non-invasive neuromodulation treatment for statistical analysis. The complete data included pure tone audiometry, tinnitus assessment (tinnitus matching, Tinnitus Handicap Inventory, Tinnitus Function Index, Visual analog Scales), mood assessments (Hamilton Anxiety Scale, Hamilton Depression Scale), and sleep quality assessment (Pittsburgh Sleep Index Scale). Paired T-tests are suppoesed to be conducted to analyze the clinical efficacy of non-invasive neuromodulation therapy for subjective tinnitus and its specific effect on improving mood and sleep.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| before non-invasive neuromodulation therapy | – | Other: before any interventionevaluation results before non-invasive neuroregulation therapy |
| after non-invasive neuromodulation therapy | – | Behavioral: non-invasive neuromodulation therapyevaluation results after six-month non-invasive neuroregulation therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjective tinnitus patients and compliance with 6 months of noninvasive neuromodulation therapy, with complete two-assessment scale records.
Key inclusion criteria (6 listed)
- ≥18yrs,
- Diagnosed as subjective tinnitus,
- THI≥38,
- Chinese, can cooperate with all Chinese version evaluation,
- Right-handed,
Key exclusion criteria (2 listed)
- Hyperacustic,
- Incomplete case data
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 |
|---|---|---|
| non-invasive neuromodulation therapyPatients with subjective tinnitus were treated using non-invasive neuroregulation therapy. That is, to generate personalized, non-invasive acoustically stimulated neuroregulation regimens for six montns. Each participant was treated three times a day (morning, noon and bedtime) for 30 minutes each time. | Behavioural | after non-invasive neuromodulation therapy |
| before any interventionbefore any intervention | Other | before non-invasive neuromodulation therapy |
Primary outcome
tinnitus loudness
Time frame: 0-7 days pre-therapy, 0-7 days post-therapy
Taking 1dB as the step, parrticipants were asked to select the signal sound intensity consistent with their subjective tinnitus loudness, and the tinnitus loudness matching was completed after repeated testing. The difference between the matched intensity and the pure tone hearing threshold at this frequency was recorded as tinnitus loudness (dB SL).
tinnitus handicap inventory, THI
Time frame: 0-7 days pre-therapy, 0-7 days post-therapy
THI is divided into three sub-scales, namely functional, emotional and catastrophic. THI contains a total of 25 items, and each item is scored 4, 2 and 0 points according to \"yes\", \"sometimes\" and \"no\" respectively. After each item score was completed, the THI total score, THI functional total score (THI-F), THI affective total score (THI-E), and THI catastrophic total score (THI-C) were calculated for the specific patient. The severity of tinnitus was evaluated according to the total score: 1-16 points, grade 1 (slight); 18-36 points, grade 2 (mild); 38-56pointks, grade 3 (moderate); 58-76 points, level 4 (severe); Score 78-100, level 5 (catastrophic).
tinnitus functional index, TFI
Time frame: 0-7 days pre-therapy, 0-7 days post-therapy
The scale contains 8 subscales. They are denoted as TFI-I (Intrusiveness) and TFI-SC (Sense of) control), TFI-C (Cognition), TFI-S (Sleep), TFI-A (Auditory), TFI-R (Relaxation), TFI-Q (Quality of life), TFI-E (Emotional) distress); A total of 25 items are included. Each item is worth 100 points. The average score of all items is recorded as the total TFI score. The higher the score, the higher the pain and severity of the subject\'s tinnitus.
visual analogue scale, VAS
Time frame: 0-7 days pre-therapy, 0-7 days post-therapy
VAS was used to evaluate the impact of tinnitus on the daily life of patients with chronic subjective tinnitus. Scale 0-10. A score of 0 means that tinnitus has no impact on daily life, and a score of 10 means that tinnitus has an intolerable, fatal level of impact on daily life. VAS was used to evaluate subjective tinnitus loudness, annoyance, depression, and tinnitus control difficulty.
3 secondary outcomes
Hamilton Anxiety Scale, HAMA
Time frame: 0-7 days pre-therapy, 0-7 days post-therapy
Hamilton depression scale, HAMD
Time frame: 0-7 days pre-therapy, 0-7 days post-therapy
Pittsburgh sleep quality index, PSQI
Time frame: 0-7 days pre-therapy, 0-7 days post-therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Individual participant dataSharing planned: No
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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.
Haidi Yang, PhD study director
SunYatSunU2H
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Subjective Tinnitus, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen 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 2 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: finished, as of the sponsor's last update on 10 Dec 2024. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tinnitus loudness (time frame: 0-7 days pre-therapy, 0-7 days post-therapy). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Dec 2024.