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Clinical Trials/NCT04118907
NCT04118907
Unknown
Not Applicable

Effects of Sound Stimulation, Somatosensory Stimulation, Vestibular Stimulation and the Combinations on Tinnitus Loudness and Tinnitus Related Distress in Patients

Dan Su1 site in 1 country120 target enrollmentJune 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Tinnitus
Sponsor
Dan Su
Enrollment
120
Locations
1
Primary Endpoint
Tinnitus disability scale
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2020
End Date
October 30, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Dan Su
Responsible Party
Sponsor Investigator
Principal Investigator

Dan Su

principal investigator

The First Affiliated Hospital of Anhui Medical University

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

Outcomes

Primary Outcomes

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.

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

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

Study Sites (1)

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