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
About this trial
This is an interventional treatment trial for Electroacupuncture
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
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
NCT ID
NCT05511753
First Posted
August 16, 2022
Last Updated
August 20, 2022
Sponsor
China Medical University Hospital
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
Learn more about this trial
The Effect of Acupuncture on Patients With Noise-induced Hearing Loss
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