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

NCT ID: NCT04118907

Last Updated: 2020-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-30

Study Completion Date

2020-10-30

Brief Summary

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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

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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.

Conditions

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Tinnitus Acoustic Stimulation Somatic Stimulation Vestibular Stimulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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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.

Group Type EXPERIMENTAL

multiple sensory stimulation

Intervention Type DEVICE

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.

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.

Group Type EXPERIMENTAL

multiple sensory stimulation

Intervention Type DEVICE

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.

vestibular stimulation

The patient sat on a rotating chair with sinusoidal harmonic acceleration and rotated without causing the greatest frequency of discomfort.

Group Type EXPERIMENTAL

multiple sensory stimulation

Intervention Type DEVICE

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.

acoustic + somatic stimulation

Combination of auditory and somatic stimulation for tinnitus patients

Group Type EXPERIMENTAL

multiple sensory stimulation

Intervention Type DEVICE

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.

acoustic + vestibular stimulation

Combination of auditory and vestibular stimulation for tinnitus patients

Group Type EXPERIMENTAL

multiple sensory stimulation

Intervention Type DEVICE

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.

acoustic + somatic + vestibular stimulation

Combination of auditory stimulation, somatic stimulation and vestibular stimulation for tinnitus patients

Group Type EXPERIMENTAL

multiple sensory stimulation

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dan Su

OTHER

Sponsor Role lead

Responsible Party

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Dan Su

principal investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Busheng Tong, doctor

Role: STUDY_DIRECTOR

E.N.T. department of the First Affiliated hospital of Anhui Medical University

Locations

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E.N.T. department of the First Affiliated hospital of Anhui Medical University

Hefei, Anhui, China

Site Status

Countries

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China

Central Contacts

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Dan Su, master

Role: CONTACT

+8615755149100

Busheng Tong, doctor

Role: CONTACT

+8613956040273

Other Identifiers

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Mssftinnitus

Identifier Type: -

Identifier Source: org_study_id

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