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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 : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Dan Su, The First Affiliated Hospital of Anhui Medical University

Tracking Information
First Submitted Date  ICMJE October 3, 2019
First Posted Date  ICMJE October 8, 2019
Last Update Posted Date February 5, 2020
Estimated Study Start Date  ICMJE June 2020
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 5, 2019)
  • 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
  • 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
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Different Stimuli Were Given to Patients With Chronic Pure Tone Tinnitus to Verify the Effective Treatment of Tinnitus.
Official Title  ICMJE Effects of Sound Stimulation, Somatosensory Stimulation, Vestibular Stimulation and the Combinations on Tinnitus Loudness and Tinnitus Related Distress in Patients
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE
  • Tinnitus
  • Acoustic Stimulation
  • Somatic Stimulation
  • Vestibular Stimulation
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Device: multiple sensory stimulation
  • 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.
    Intervention: Device: multiple sensory stimulation
  • Experimental: vestibular stimulation
    The patient sat on a rotating chair with sinusoidal harmonic acceleration and rotated without causing the greatest frequency of discomfort.
    Intervention: Device: multiple sensory stimulation
  • Experimental: acoustic + somatic stimulation
    Combination of auditory and somatic stimulation for tinnitus patients
    Intervention: Device: multiple sensory stimulation
  • Experimental: acoustic + vestibular stimulation
    Combination of auditory and vestibular stimulation for tinnitus patients
    Intervention: Device: multiple sensory stimulation
  • Experimental: acoustic + somatic + vestibular stimulation
    Combination of auditory stimulation, somatic stimulation and vestibular stimulation for tinnitus patients
    Intervention: Device: multiple sensory stimulation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: October 5, 2019)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 30, 2020
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Dan Su, master +8615755149100 sudan19966991@outlook.com
Contact: Busheng Tong, doctor +8613956040273 2871638103@qq.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04118907
Other Study ID Numbers  ICMJE Mssftinnitus
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dan Su, The First Affiliated Hospital of Anhui Medical University
Study Sponsor  ICMJE Dan Su
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Busheng Tong, doctor E.N.T. department of the First Affiliated hospital of Anhui Medical University
PRS Account The First Affiliated Hospital of Anhui Medical University
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP