- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05511753
The Effect of Acupuncture on Patients With Noise-induced Hearing Loss
The Effect of Acupuncture on Patients With Noise-induced Hearing Loss -- Randomized, Single-blinded, Controlled Prospective Clinical Trial
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: pure tone audiometry improving
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pure tone audiometry observe changes in hearing
Time Frame: Before acupuncture treatment, 2 weeks, 4 weeks, 6 weeks after treatment, and 2 weeks after acupuncture treatment
|
The pure tone test measures the hearing thresholds of 2KHz, 4KHz and 8KHz respectively.
|
Before acupuncture treatment, 2 weeks, 4 weeks, 6 weeks after treatment, and 2 weeks after acupuncture treatment
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CMUH110-REC1-240
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Noise Induced Hearing Loss
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University Hospital, AntwerpUnknownNoise-induced Hearing Loss | Noise-induced TinnitusBelgium
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University of MichiganNational Institute on Deafness and Other Communication Disorders (NIDCD); Progressive...CompletedNoise-induced Hearing LossUnited States
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Otologic Pharmaceutics, Inc.CompletedHearing Loss | Sensorineural Hearing Loss | Noise-Induced Hearing LossUnited States
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University of MichiganUniversity of Florida; National Institute on Deafness and Other Communication... and other collaboratorsCompleted
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