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

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ClinicalTrials.gov Identifier: NCT04118907
Recruitment Status : Not yet recruiting
First Posted : October 8, 2019
Last Update Posted : October 15, 2019
Sponsor:
Information provided by (Responsible Party):
Dan Su, The First Affiliated Hospital of Anhui Medical University

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

Condition or disease Intervention/treatment Phase
Tinnitus Acoustic Stimulation Somatic Stimulation Vestibular Stimulation Device: multiple sensory stimulation Not Applicable

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.

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Study Type : Interventional
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Effects of Sound Stimulation, Somatosensory Stimulation, Vestibular Stimulation and the Combinations on Tinnitus Loudness and Tinnitus Related Distress in Patients
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : January 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus

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.




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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.



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04118907


Contacts
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Contact: Dan Su, master +8615755149100 sudan19966991@outlook.com
Contact: Busheng Tong, doctor +8613956040273 2871638103@qq.com

Locations
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China, Anhui
E.N.T. department of the First Affiliated hospital of Anhui Medical University
Hefei, Anhui, China, 230000
Sponsors and Collaborators
Dan Su
Investigators
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Study Director: Busheng Tong, doctor E.N.T. department of the First Affiliated hospital of Anhui Medical University

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Responsible Party: Dan Su, principal investigator, The First Affiliated Hospital of Anhui Medical University
ClinicalTrials.gov Identifier: NCT04118907     History of Changes
Other Study ID Numbers: Mssftinnitus
First Posted: October 8, 2019    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dan Su, The First Affiliated Hospital of Anhui Medical University:
tinnitus
stimulation
Additional relevant MeSH terms:
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Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms