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The Effect of Acupuncture on Patients With Noise-induced Hearing Loss

Primary Purpose

Electroacupuncture, Noise Induced Hearing Loss, Hearing Loss, Noise-Induced

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
electroacupuncture
Sponsored by
China Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Electroacupuncture

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • pure tone audiometry diagnosed noise-induced hearing loss
  • age: 20 - 65

Exclusion Criteria:

  • major medical disease -- cancer, renal disease
  • pregnancy or milk women
  • anti-coagulation use
  • pacemaker use
  • allergy to needle
  • denied accept inform consent

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    pure tone audiometry improving

    Arm Description

    Pure tone audiometry: observe changes in hearing ability Evaluation time: Before acupuncture treatment, 2 weeks, 4 weeks, 6 weeks after treatment, and 2 weeks after acupuncture treatment, pure-tone audiometry was performed. The pure tone audiometry measures the hearing thresholds of 2KHz, 4KHz and 8KHz respectively.

    Outcomes

    Primary Outcome Measures

    pure tone audiometry observe changes in hearing
    The pure tone test measures the hearing thresholds of 2KHz, 4KHz and 8KHz respectively.

    Secondary Outcome Measures

    Full Information

    First Posted
    August 16, 2022
    Last Updated
    August 20, 2022
    Sponsor
    China Medical University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05511753
    Brief Title
    The Effect of Acupuncture on Patients With Noise-induced Hearing Loss
    Official Title
    The Effect of Acupuncture on Patients With Noise-induced Hearing Loss -- Randomized, Single-blinded, Controlled Prospective Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2022 (Anticipated)
    Primary Completion Date
    July 30, 2023 (Anticipated)
    Study Completion Date
    September 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    China Medical University Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    In an era of advanced industry and commerce, working in a noisy environment is one of the most important risk factors for hearing damage, especially among young and middle-aged people. Although acupuncture has been widely used to treat otology-related diseases, such as tinnitus, dizziness, and sudden deafness, there are few studies on the effect of noise-induced hearing loss.
    Detailed Description
    Therefore, the purpose of this study is to investigate the effect of acupuncture on patients with noise-induced hearing loss. This study is designed as a randomized, single-blind, control prospective clinical trial. Eighty subjects with noise-induced hearing loss were included in the criteria and randomly divided into the acupuncture group and the control group as follows: 1) In the acupuncture group, in addition to the conventional treatment, acupuncture on both sides of Baihui (GV20), Dazhui (GV14), Yifeng (TE17), Wangu (GB12), Zhongzhu (TE3), Quchi (LI11), and connecting Yifeng and Wangu, and Zhongzhu and Quchi are given electroacupuncture stimulation (intensity of 1mA, frequency of 2Hz), 3 times a week, 15 minutes each time, continuous 6 weeks; 2) The control group was given conventional treatment only. The main assessment is the hearing changes of the pure tone hearing test, which measure the hearing thresholds of 2KHz, 4KHz, and 8KHz respectively; the secondary assessment is the change of the tinnitus handicap index score. The evaluation time includes before acupuncture treatment, 2 weeks, 4 weeks, 6 weeks after treatment, and 2 weeks after the end of acupuncture treatment. The results of this study are expected to prove that acupuncture can improve noise-induced hearing loss.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Electroacupuncture, Noise Induced Hearing Loss, Hearing Loss, Noise-Induced

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    pure tone audiometry improving
    Arm Type
    Experimental
    Arm Description
    Pure tone audiometry: observe changes in hearing ability Evaluation time: Before acupuncture treatment, 2 weeks, 4 weeks, 6 weeks after treatment, and 2 weeks after acupuncture treatment, pure-tone audiometry was performed. The pure tone audiometry measures the hearing thresholds of 2KHz, 4KHz and 8KHz respectively.
    Intervention Type
    Device
    Intervention Name(s)
    electroacupuncture
    Intervention Description
    Insert stainless steel needles into the above acupoints and twist the needles to get qi. In addition, electroacupuncture stimulation (intensity 1mA, frequency 2Hz) was applied to connect the ipsilateral Yifeng and Wangu, and the ipsilateral Zhongzhu and Quchi.
    Primary Outcome Measure Information:
    Title
    pure tone audiometry observe changes in hearing
    Description
    The pure tone test measures the hearing thresholds of 2KHz, 4KHz and 8KHz respectively.
    Time Frame
    Before acupuncture treatment, 2 weeks, 4 weeks, 6 weeks after treatment, and 2 weeks after acupuncture treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: pure tone audiometry diagnosed noise-induced hearing loss age: 20 - 65 Exclusion Criteria: major medical disease -- cancer, renal disease pregnancy or milk women anti-coagulation use pacemaker use allergy to needle denied accept inform consent

    12. IPD Sharing Statement

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    The Effect of Acupuncture on Patients With Noise-induced Hearing Loss

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