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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04118907
Other study ID # Mssftinnitus
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 2020
Est. completion date October 30, 2020

Study information

Verified date February 2020
Source The First Affiliated Hospital of Anhui Medical University
Contact Dan Su, master
Phone +8615755149100
Email sudan19966991@outlook.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 120
Est. completion date October 30, 2020
Est. primary completion date July 2020
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility 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 Design


Intervention

Device:
multiple sensory stimulation
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.

Locations

Country Name City State
China E.N.T. department of the First Affiliated hospital of Anhui Medical University Hefei Anhui

Sponsors (1)

Lead Sponsor Collaborator
Dan Su

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
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