Different Stimuli Were Given to Patients With Chronic Pure Tone Tinnitus to Verify the Effective Treatment of Tinnitus.

Tinnitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04118907
• Other study ID #: Mssftinnitus
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Acoustic Stimulation
• Somatic Stimulation
• Tinnitus
• Vestibular Stimulation

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