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

Not Applicable

• Conditions: Acoustic Stimulation; Tinnitus; Somatic Stimulation; Vestibular Stimulation
• Interventions: Device: multiple sensory stimulation

• Registration Number: NCT04118907
• Lead Sponsor: Dan Su

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.

Study Timeline

• Study First Submitted: 2019-10-03
• Study First Submitted QC: 2019-10-05
• Study First Posted: 2019-10-08
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-04
• Last Update Posted: 2020-02-05
• Study Start: 2020-06
• Primary Completion: 2020-07
• Study Completion: 2020-10-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
vestibular stimulation	multiple sensory stimulation	The patient sat on a rotating chair with sinusoidal harmonic acceleration and rotated without causing the greatest frequency of discomfort.
acoustic + vestibular stimulation	multiple sensory stimulation	Combination of auditory and vestibular stimulation for tinnitus patients
somatic stimulation	multiple sensory 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.
acoustic + somatic stimulation	multiple sensory stimulation	Combination of auditory and somatic stimulation for tinnitus patients
acoustic + somatic + vestibular stimulation	multiple sensory stimulation	Combination of auditory stimulation, somatic stimulation and vestibular stimulation for tinnitus patients
acoustic stimulation	multiple sensory 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.

Primary Outcome Measures

Name	Time	Method
Tinnitus disability scale	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	Three months from the time the patient was selected to the end of the stimulus	Assessment of hearing in patients
Tinnitus frequency and loudness	Three months from the time the patient was selected to the end of the stimulus	Detection of tinnitus frequency and loudness in patients

Trial Locations

Locations (1)

E.N.T. department of the First Affiliated hospital of Anhui Medical University; 🇨🇳 Hefei, Anhui, China