ElectroacupunctureNCT05511753
The Effect of Acupuncture on Patients With Noise-induced Hearing Loss
A study testing electroacupuncture in people with Electroacupuncture and Noise Induced Hearing Loss, run by China Medical University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Electroacupuncture, Noise Induced Hearing Loss, Hearing Loss, Noise-Induced
- What is being tested?
- electroacupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2022to 1 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pure tone audiometry diagnosed noise-induced hearing loss
- age: 20 - 65
Who cannot join
- major medical disease -- cancer, renal disease
- pregnancy or milk women
- anti-coagulation use
- pacemaker use
- allergy to needle
- denied accept inform consent
About this study
Official title: The Effect of Acupuncture on Patients With Noise-induced Hearing Loss -- Randomized, Single-blinded, Controlled Prospective Clinical Trial
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.
Read the 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.
- Being tested
- electroacupuncture
- Medical subject headings
- Hearing Loss, Noise-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electroacupunctureDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| pure tone audiometry improving | Experimental | 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. Receives: Device: electroacupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
pure tone audiometry observe changes in hearing
The pure tone test measures the hearing thresholds of 2KHz, 4KHz and 8KHz respectively.
Measured: Before acupuncture treatment, 2 weeks, 4 weeks, 6 weeks after treatment, and 2 weeks after acupuncture treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2022
- Study start1 Sep 2022 (estimated)
- Primary completion30 Jul 2023 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElectroacupunctureStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05511753
- Sponsor's protocol ID
- CMUH110-REC1-240
- Status last verified
- Aug 2022
- First submitted
- 16 Aug 2022
- Last updated
- 23 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Acupuncture on Patients With Noise-induced Hearing Loss -- Randomized, Single-blinded, Controlled Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT05511753
- Acronym / sponsor ID
- CMUH110-REC1-240
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 30 Jul 2023 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 23 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pure tone audiometry improving | Experimental | Device: electroacupuncturePure 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. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- pure tone audiometry diagnosed noise-induced hearing loss
- age: 20 - 65
Key exclusion criteria (6 listed)
- major medical disease -- cancer, renal disease
- pregnancy or milk women
- anti-coagulation use
- pacemaker use
- allergy to needle
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electroacupunctureInsert 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. | Device | pure tone audiometry improving |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing electroacupuncture in people with Electroacupuncture and Noise Induced Hearing Loss, run by China Medical University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2022.