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

Conditions

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 Locations

  • China
    • 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.
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.
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.
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.
Experimental: vestibular stimulation
The patient sat on a rotating chair with sinusoidal harmonic acceleration and rotated without causing the greatest frequency of discomfort.
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.
Experimental: acoustic + somatic stimulation
Combination of auditory and somatic stimulation for tinnitus patients
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.
Experimental: acoustic + vestibular stimulation
Combination of auditory and vestibular stimulation for tinnitus patients
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.
Experimental: acoustic + somatic + vestibular stimulation
Combination of auditory stimulation, somatic stimulation and vestibular stimulation for tinnitus patients
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.

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
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

Dan Su

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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