Back to resultsDifferent Stimuli Were Given to Patients With Chronic Pure Tone Tinnitus to Verify the Effective Treatment of Tinnitus.
Primary Purpose
Tinnitus, Acoustic Stimulation, Somatic Stimulation
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
multiple sensory stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Tinnitus focused on measuring tinnitus, stimulation
Eligibility Criteria
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
Sites / Locations
- E.N.T. department of the First Affiliated hospital of Anhui Medical University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
acoustic stimulation
somatic stimulation
vestibular stimulation
acoustic + somatic stimulation
acoustic + vestibular stimulation
acoustic + somatic + vestibular stimulation
Arm Description
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.
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 patient sat on a rotating chair with sinusoidal harmonic acceleration and rotated without causing the greatest frequency of discomfort.
Combination of auditory and somatic stimulation for tinnitus patients
Combination of auditory and vestibular stimulation for tinnitus patients
Combination of auditory stimulation, somatic stimulation and vestibular stimulation for tinnitus patients
Outcomes
Primary Outcome Measures
Electrical audiometry and acoustic impedance
Assessment of hearing in patients
Tinnitus frequency and loudness
Detection of tinnitus frequency and loudness in patients
Tinnitus disability scale
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04118907
Brief Title
Different Stimuli Were Given to Patients With Chronic Pure Tone Tinnitus to Verify the Effective Treatment of Tinnitus.
Official Title
Effects of Sound Stimulation, Somatosensory Stimulation, Vestibular Stimulation and the Combinations on Tinnitus Loudness and Tinnitus Related Distress in Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 2020 (Anticipated)
Primary Completion Date
July 2020 (Anticipated)
Study Completion Date
October 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dan Su
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus, Acoustic Stimulation, Somatic Stimulation, Vestibular Stimulation
Keywords
tinnitus, stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
acoustic stimulation
Arm Type
Experimental
Arm Description
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.
Arm Title
somatic stimulation
Arm Type
Experimental
Arm Description
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.
Arm Title
vestibular stimulation
Arm Type
Experimental
Arm Description
The patient sat on a rotating chair with sinusoidal harmonic acceleration and rotated without causing the greatest frequency of discomfort.
Arm Title
acoustic + somatic stimulation
Arm Type
Experimental
Arm Description
Combination of auditory and somatic stimulation for tinnitus patients
Arm Title
acoustic + vestibular stimulation
Arm Type
Experimental
Arm Description
Combination of auditory and vestibular stimulation for tinnitus patients
Arm Title
acoustic + somatic + vestibular stimulation
Arm Type
Experimental
Arm Description
Combination of auditory stimulation, somatic stimulation and vestibular stimulation for tinnitus patients
Intervention Type
Device
Intervention Name(s)
multiple sensory stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Electrical audiometry and acoustic impedance
Description
Assessment of hearing in patients
Time Frame
Three months from the time the patient was selected to the end of the stimulus
Title
Tinnitus frequency and loudness
Description
Detection of tinnitus frequency and loudness in patients
Time Frame
Three months from the time the patient was selected to the end of the stimulus
Title
Tinnitus disability scale
Description
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.
Time Frame
Three months from the time the patient was selected to the end of the stimulus
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dan Su, master
Phone
+8615755149100
Email
sudan19966991@outlook.com
First Name & Middle Initial & Last Name or Official Title & Degree
Busheng Tong, doctor
Phone
+8613956040273
Email
2871638103@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Busheng Tong, doctor
Organizational Affiliation
E.N.T. department of the First Affiliated hospital of Anhui Medical University
Official's Role
Study Director
Facility Information:
Facility Name
E.N.T. department of the First Affiliated hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230000
Country
China
12. IPD Sharing Statement
Learn more about this trial
Different Stimuli Were Given to Patients With Chronic Pure Tone Tinnitus to Verify the Effective Treatment of Tinnitus.
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