Ignite Creation Date:
2024-05-06 @ 7:18 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05964725
Status:
RECRUITING
Last Update Posted:
2023-11-27
First Post:
2023-07-16
Brief Title:
The Study on Effect and Neural Network Mechanism of Transcranial Direct Current Stimulation for Sudden Deafness With Tinnitus
Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Organization:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study Overview
Official Title:
The Study on Effect and Neural Network Mechanism of Transcranial Direct Current Stimulation for Sudden Deafness With Tinnitus
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This clinical study is prospective single-center randomized controlled double-blind clinical trail which entitled transcranial electrical stimulation for the treatment of acute tinnitus approved by Sun Yat-sen University and intends to recruit 86 patients with sudden deafness and tinnitus For acute subjective tinnitus a common otological disease the study gave the experimental group patients received tDCS with electrodes positioned over the left temporal cortex for 5 days To assess the efficacy of conventional medical therapy and tDCS by comparing changes in anterior and posterior tinnitus-related subjective scale scores such as THI VAS BAI BDI PSQI and hearing recovery in patients who received tDCS to determine whether tDCS is effective in improving acute tinnitus and whether it is superior to conventional tinnitus treatment In addition the study will continue to follow patients for 1 month3 months and 6 months after the end of treatment to observe the long-term sustained efficacy of tDCS This clinical trail will also evaluate tDCS from the perspective of compliance and safety and explore the factors affecting the efficacy of this therapy
Detailed Description:
Sample size estimation
On-site recruitment will be conducted in the otolaryngology clinic for eligible patients with sudden deafness and tinnitus with dedicated personnel to recruit subjects with a total of at least 86 expected recruitment In order to retain subjects staff will tell them about the benefits of inclusion in clinical studies for sudden deafness with tinnitus and actively add subjects contact information to provide relevant consulting services for subjects during clinical studies During follow-up participants will be provided with a free tinnitus-related assessment test to motivate
Plan for missing data Screening failure ie subjects did not meet the inclusion and exclusion criteria or subjects withdrew informed consent among other things for reasons why it was not included in this clinical study Study subjects who failed to screen will be pressed according to their own condition Provide appropriate treatment according to clinical guidelines This subset of subjects will not be included in clinical studies
Statistical analysis plan
When considering the influence of baseline the continuous variables were analyzed by covariance analysis and the qualitative indicators were tested by CMH test or logistic regression
Primary analysis Using covariance analysis to compare the different changes of THI scores between two groups after 5 days treatment controlled for age and baseline THI
Secondary analysis Using covariance analysis to compare the different changes of VAS BAI BDI PSQI scores between two groups after 5 days treatment controlled for age and baseline values corresponding to each scale
Using a repeated measure ANOVA to compare the different changes of THI VAS BAI BDI PSQI between two groups at 1 3 and 6 follow-up visits
Using Chi square test or Fisher exact test to compare the different efficient rate between two groups after 5 days treatment
Exploratory analysis
Using multiple linear regression analysis to explore the factors affecting the short-term and long -term efficacy of the two treatments such as age hearing loss threshold tinnitus loudness tinnitus frequency and so on
Using Independent two sample t-test or nonparametric analysis to compare the differences in EEG- or fMRI-related indicators between two groups
Safety analysis
Using Pearsons chi-square test to compare the difference of adverse event incidence rate between two groups
On-site recruitment will be conducted in the otolaryngology clinic for eligible patients with sudden deafness and tinnitus with dedicated personnel to recruit subjects with a total of at least 86 expected recruitment In order to retain subjects staff will tell them about the benefits of inclusion in clinical studies for sudden deafness with tinnitus and actively add subjects contact information to provide relevant consulting services for subjects during clinical studies During follow-up participants will be provided with a free tinnitus-related assessment test to motivate
Plan for missing data Screening failure ie subjects did not meet the inclusion and exclusion criteria or subjects withdrew informed consent among other things for reasons why it was not included in this clinical study Study subjects who failed to screen will be pressed according to their own condition Provide appropriate treatment according to clinical guidelines This subset of subjects will not be included in clinical studies
Statistical analysis plan
When considering the influence of baseline the continuous variables were analyzed by covariance analysis and the qualitative indicators were tested by CMH test or logistic regression
Primary analysis Using covariance analysis to compare the different changes of THI scores between two groups after 5 days treatment controlled for age and baseline THI
Secondary analysis Using covariance analysis to compare the different changes of VAS BAI BDI PSQI scores between two groups after 5 days treatment controlled for age and baseline values corresponding to each scale
Using a repeated measure ANOVA to compare the different changes of THI VAS BAI BDI PSQI between two groups at 1 3 and 6 follow-up visits
Using Chi square test or Fisher exact test to compare the different efficient rate between two groups after 5 days treatment
Exploratory analysis
Using multiple linear regression analysis to explore the factors affecting the short-term and long -term efficacy of the two treatments such as age hearing loss threshold tinnitus loudness tinnitus frequency and so on
Using Independent two sample t-test or nonparametric analysis to compare the differences in EEG- or fMRI-related indicators between two groups
Safety analysis
Using Pearsons chi-square test to compare the difference of adverse event incidence rate between two groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None