- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04118907
Different Stimuli Were Given to Patients With Chronic Pure Tone Tinnitus to Verify the Effective Treatment of Tinnitus.
February 4, 2020 updated by: Dan Su
Effects of Sound Stimulation, Somatosensory Stimulation, Vestibular Stimulation and the Combinations on Tinnitus Loudness and Tinnitus Related Distress in Patients
In this experiment, patients with chronic pure tone tinnitus were divided into three groups to receive auditory stimulation, somatosensory stimulation, vestibular stimulation and combined stimulation, in order to find an effective way to treat tinnitus
Study Overview
Status
Unknown
Intervention / Treatment
Detailed Description
120 patients with chronic pure tone tinnitus over 6 months were randomly divided into 6 groups, one group was given auditory stimulation, one group was given somatosensory stimulation, one group was given auditory stimulation + somatosensory stimulation, one group was given auditory stimulation + vestibular stimulation, the last group was given auditory stimulation + somatosensory stimulation + vestibular stimulation.
Study Type
Interventional
Enrollment (Anticipated)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Dan Su, master
- Phone Number: +8615755149100
- Email: sudan19966991@outlook.com
Study Contact Backup
- Name: Busheng Tong, doctor
- Phone Number: +8613956040273
- Email: 2871638103@qq.com
Study Locations
-
-
Anhui
-
Hefei, Anhui, China, 230000
- E.N.T. department of the First Affiliated hospital of Anhui Medical University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Pure tone tinnitus
- Unilateral and bilateral
- female and male
- Tinnitus has a history of more than 6 months
Exclusion Criteria:
- Pulsatile tinnitus of blood vessel
- Meniere's disease
- Chronic headache
- Neurological diseases (such as brain tumors)
- Patients with mental / mental illness undergoing treatment
- Pregnant women and patients with other untreatable diseases
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: acoustic stimulation
Pink noise in both ears is given to tinnitus patients.
The pink noise is removed by notch filter from tinnitus frequencies that are 20 decibel higher than the threshold.
|
The patients were recruited to record their medical history, and the hearing level, tinnitus indicators, vestibular function and tinnitus disability indicators were tested.
Then the patients were randomly divided into six groups.
They received the corresponding stimulation 20 minutes a day, 5 days a week for 3 weeks.
After the last stimulation, the above tests were repeated immediately, one week later and three months later.
|
Experimental: somatic stimulation
Three stimulation points were selected for each ear of tinnitus patients, namely ear door (CN.V), auditory Palace (CN.VII) and Yifeng (C2/3).
The stimulation intensity should be needle-sensed.
|
The patients were recruited to record their medical history, and the hearing level, tinnitus indicators, vestibular function and tinnitus disability indicators were tested.
Then the patients were randomly divided into six groups.
They received the corresponding stimulation 20 minutes a day, 5 days a week for 3 weeks.
After the last stimulation, the above tests were repeated immediately, one week later and three months later.
|
Experimental: vestibular stimulation
The patient sat on a rotating chair with sinusoidal harmonic acceleration and rotated without causing the greatest frequency of discomfort.
|
The patients were recruited to record their medical history, and the hearing level, tinnitus indicators, vestibular function and tinnitus disability indicators were tested.
Then the patients were randomly divided into six groups.
They received the corresponding stimulation 20 minutes a day, 5 days a week for 3 weeks.
After the last stimulation, the above tests were repeated immediately, one week later and three months later.
|
Experimental: acoustic + somatic stimulation
Combination of auditory and somatic stimulation for tinnitus patients
|
The patients were recruited to record their medical history, and the hearing level, tinnitus indicators, vestibular function and tinnitus disability indicators were tested.
Then the patients were randomly divided into six groups.
They received the corresponding stimulation 20 minutes a day, 5 days a week for 3 weeks.
After the last stimulation, the above tests were repeated immediately, one week later and three months later.
|
Experimental: acoustic + vestibular stimulation
Combination of auditory and vestibular stimulation for tinnitus patients
|
The patients were recruited to record their medical history, and the hearing level, tinnitus indicators, vestibular function and tinnitus disability indicators were tested.
Then the patients were randomly divided into six groups.
They received the corresponding stimulation 20 minutes a day, 5 days a week for 3 weeks.
After the last stimulation, the above tests were repeated immediately, one week later and three months later.
|
Experimental: acoustic + somatic + vestibular stimulation
Combination of auditory stimulation, somatic stimulation and vestibular stimulation for tinnitus patients
|
The patients were recruited to record their medical history, and the hearing level, tinnitus indicators, vestibular function and tinnitus disability indicators were tested.
Then the patients were randomly divided into six groups.
They received the corresponding stimulation 20 minutes a day, 5 days a week for 3 weeks.
After the last stimulation, the above tests were repeated immediately, one week later and three months later.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Electrical audiometry and acoustic impedance
Time Frame: Three months from the time the patient was selected to the end of the stimulus
|
Assessment of hearing in patients
|
Three months from the time the patient was selected to the end of the stimulus
|
Tinnitus frequency and loudness
Time Frame: Three months from the time the patient was selected to the end of the stimulus
|
Detection of tinnitus frequency and loudness in patients
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Three months from the time the patient was selected to the end of the stimulus
|
Tinnitus disability scale
Time Frame: Three months from the time the patient was selected to the end of the stimulus
|
Tinnitus handicap inventory score was used to detect the degree of tinnitus.0-16
points without disability, 18-36 points with mild disability, 38-56 points with moderate disability and 58-100 points with severe disability.
The 95% confidence interval is 20 points, that is, the difference between the two tests before and after the experiment is greater than or equal to 20 points.
|
Three months from the time the patient was selected to the end of the stimulus
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Busheng Tong, doctor, E.N.T. department of the First Affiliated hospital of Anhui Medical University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
June 1, 2020
Primary Completion (Anticipated)
July 1, 2020
Study Completion (Anticipated)
October 30, 2020
Study Registration Dates
First Submitted
October 3, 2019
First Submitted That Met QC Criteria
October 5, 2019
First Posted (Actual)
October 8, 2019
Study Record Updates
Last Update Posted (Actual)
February 5, 2020
Last Update Submitted That Met QC Criteria
February 4, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Mssftinnitus
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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