Different Stimuli Were Given to Patients With Chronic Pure Tone Tinnitus to Verify the Effective Treatment of Tinnitus.
Effects of Sound Stimulation, Somatosensory Stimulation, Vestibular Stimulation and the Combinations on Tinnitus Loudness and Tinnitus Related Distress in Patients
1 other identifier
interventional
120
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 3, 2019
CompletedFirst Posted
Study publicly available on registry
October 8, 2019
CompletedStudy Start
First participant enrolled
June 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2020
CompletedFebruary 5, 2020
February 1, 2020
1 month
October 3, 2019
February 4, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Electrical audiometry and acoustic impedance
Assessment of hearing in patients
Three months from the time the patient was selected to the end of the stimulus
Tinnitus frequency and loudness
Detection of tinnitus frequency and loudness in patients
Three months from the time the patient was selected to the end of the stimulus
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.
Three months from the time the patient was selected to the end of the stimulus
Study Arms (6)
acoustic stimulation
EXPERIMENTALPink 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.
somatic stimulation
EXPERIMENTALThree 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.
vestibular stimulation
EXPERIMENTALThe patient sat on a rotating chair with sinusoidal harmonic acceleration and rotated without causing the greatest frequency of discomfort.
acoustic + somatic stimulation
EXPERIMENTALCombination of auditory and somatic stimulation for tinnitus patients
acoustic + vestibular stimulation
EXPERIMENTALCombination of auditory and vestibular stimulation for tinnitus patients
acoustic + somatic + vestibular stimulation
EXPERIMENTALCombination of auditory stimulation, somatic stimulation and vestibular stimulation for tinnitus patients
Interventions
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.
Eligibility Criteria
You may qualify if:
- Pure tone tinnitus
- Unilateral and bilateral
- female and male
- Tinnitus has a history of more than 6 months
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dan Sulead
Study Sites (1)
E.N.T. department of the First Affiliated hospital of Anhui Medical University
Hefei, Anhui, 230000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Busheng Tong, doctor
E.N.T. department of the First Affiliated hospital of Anhui Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
October 3, 2019
First Posted
October 8, 2019
Study Start
June 1, 2020
Primary Completion
July 1, 2020
Study Completion
October 30, 2020
Last Updated
February 5, 2020
Record last verified: 2020-02