Sudden Hearing LossNCT07235488
Effectiveness of Integrative Medical Treatment in Sudden Hearing Loss
A study testing Acupuncture and steroid therapy in people with Sudden Hearing Loss, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
Sudden hearing loss is an emergency in otolaryngology that requires diagnosis and treatment as soon as possible. The golden treatment period is two weeks since the onset of the disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sudden Hearing Loss
- What is being tested?
- Acupuncture and steroid therapy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Jul 2024to 20 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years, both male and female.
- Meeting the diagnostic criteria for sudden sensorineural hearing loss (SSNHL), defined as hearing loss of >30 dB affecting at least three consecutive frequencies within 3 days.
- Newly onset of hearing loss within 2 week.
- Fully understanding the purpose and procedures of the study and providing signed informed consent.
Who cannot join
- Central nervous system lesions such as vestibular schwannoma or traumatic brain injury.
- Middle ear or retrocochlear pathology.
- History of otologic surgery.
- Hemorrhagic disorders or coagulation abnormalities.
- Inability to cooperate with examinations due to dementia or psychiatric illness.
- Previous treatment for SSNHL on the same affected side within the past 6 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
China Medical University Hospital
Taichung
Ming-Cheng Huang, M.D., Ph.D., +886-4-22052121 Ext. 14561, mchuang1128@gmail.com
About this study
Sudden hearing loss is an emergency in otolaryngology that requires diagnosis and treatment as soon as possible. The golden treatment period is two weeks since the onset of the disease. However, modern medicine is still unable to fully understand the causes of the disease and in lack of corresponding effective treatments. Current therapies also have their own limitations and side effects. To find an effective and safe treatment, integrating with modern medicine and providing inpatient and outpatient medical care, is an important issue in clinical care. Traditional Chinese medicine has been clinically utilized for a long time with accumulated empirical experience and evidence for its efficacy. It can be used as an alternative therapeutic option for sudden hearing loss.
Being with a long period of clinical experience and evidence-based curative effect, acupuncture could be applied as an adjunctive treatment for the sudden hearing loss. Currently, this patient-centered, pragmatic clinical trial compares the effectiveness of using west medicine、combination of west medicine and traditional Chinese medicine. The aim of this study is to explore acceptable and beneficial strategy to reduce the clinical symptoms, to improve quality of life, and decrease medical expenses.
Read the detailed description
Patients newly diagnosed with sudden deafness were randomly assigned in a 1:1 ratio to two groups: a Western medicine group and an integrated Chinese and Western medicine treatment group. Each group included 32 patients, for a total of 64 patients. Treatment lasted four weeks, starting from the date of admission, and included both inpatient and outpatient care.
Western Medicine Treatment: During hospitalization, intravenous steroids were administered. After discharge, oral steroids were administered. For patients who did not respond well to treatment, intratympanic steroid injections were performed.
Traditional Chinese Medicine Treatment: Acupuncture was performed once daily for 30 minutes at acupoints around the ear and upper limb on the same side as the affected ear. Six treatment sessions were performed in the first and second weeks, and two sessions were performed in the third and fourth weeks.
Primary Outcome: Pure-tone audiograms were performed at baseline, week 1, week 2, and week 4.
Secondary Outcome: Tinnitus Handicap Inventory and Dizziness Handicap Inventory were performed at baseline, week 1, week 2, and week 4. Blood biochemistry tests were performed at baseline. Adverse events were recorded throughout the trial.
- Conditions
- Sudden Hearing Loss
- Being tested
- Acupuncture, steroid therapy
- Keywords
- sudden hearing loss, acupuncture
- Medical subject headings
- Hearing Loss, Sudden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureDevice
Treatment lasted four weeks, starting from the date of admission, and included both inpatient and outpatient care.
Western Medicine Treatment : During hospitalization, intravenous steroids were administered. After discharge, oral steroids were administered. For patients who did not respond well to treatment, intratympanic steroid injections were performed.
Traditional Chinese Medicine Treatment : Acupuncture was performed on peri-auricular and ipsilateral upper limb points, including Ermen (TE21), Tinggong (SI19), Tinghui (GB2), Shuaigu (GB8), Yifeng (TE17), Waiguan (TE5), and Zhongzhu (TE3). The treatment was administered once daily for 30 minutes. During the first and second weeks, a total of six sessions were carried out, followed by two sessions per week in the third and fourth weeks.
steroid therapyDrug
Treatment lasted four weeks, starting from the date of admission, and included both inpatient and outpatient care.
Western Medicine Treatment : During hospitalization, intravenous steroids were administered. After discharge, oral steroids were administered. For patients who did not respond well to treatment, intratympanic steroid injections were performed.
| Study group | Role | What they receive |
|---|---|---|
| Steroid therapy combined with acupuncture | Experimental | Western Medicine Treatment: During hospitalization, intravenous steroids were administered. After discharge, oral steroids were administered. For patients who did not respond well to treatment, intratympanic steroid injections were performed.
Traditional Chinese Medicine Treatment: Acupuncture was performed once daily for 30 minutes at acupoints around the ear and upper limb on the same side as the affected ear. Six treatment sessions were performed in the first and second weeks, and two sessions were performed in the third and fourth weeks. Receives: Device: Acupuncture |
| Steroid therapy | Active comparator | Western Medicine Treatment: During hospitalization, intravenous steroids were administered. After discharge, oral steroids were administered. For patients who did not respond well to treatment, intratympanic steroid injections were performed. Receives: Drug: steroid therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pure-tone audiograms
Changes from baseline to week 1, week 2, and week 4 of the intervention
Measured: baseline, week 1, week 2, and week 4
Secondary outcomes (5)
Tinnitus Handicap Inventory
Changes from baseline to week 1, week 2, and week 4 of intervention
Measured: baseline, week 1, week 2, and week 4
Dizziness Handicap Inventory
Changes from baseline to week 1, week 2, and week 4 of intervention
Measured: baseline, week 1, week 2, and week 4
Blood examination
neutrophil-to-lymphocyte ratio (NLR)
Measured: baseline
Laboratory examination
inflammatory cytokine test (IL-1β, IL-6, TNF-α)
Measured: baseline
Adverse events
Adverse events related to steroid or acupuncture therapy were recorded throughout the trial.
Measured: baseline, week 1, week 2, and week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start8 Jul 2024
- Primary completion20 May 2026 (estimated)
- Study completion20 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sudden Hearing LossStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 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
- NCT07235488
- Sponsor's protocol ID
- CMUH113-REC2-096
- Status last verified
- Nov 2025
- First submitted
- 23 Sep 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Integrative Medical Treatment in Sudden Hearing Loss
- ClinicalTrials.gov ID
- NCT07235488
- Acronym / sponsor ID
- CMUH113-REC2-096
- Conditions
- Sudden Hearing Loss
- Keywords
- sudden hearing loss, acupuncture
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 8 Jul 2024 (actual)
- Primary completion
- 20 May 2026 (estimated)
- Study completion
- 20 Jun 2026 (estimated)
- First posted
- 19 Nov 2025 (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.
Sudden hearing loss is an emergency in otolaryngology that requires diagnosis and treatment as soon as possible. The golden treatment period is two weeks since the onset of the disease. However, modern medicine is still unable to fully understand the causes of the disease and in lack of corresponding effective treatments. Current therapies also have their own limitations and side effects. To find an effective and safe treatment, integrating with modern medicine and providing inpatient and outpatient medical care, is an important issue in clinical care. Traditional Chinese medicine has been clinically utilized for a long time with accumulated empirical experience and evidence for its efficacy. It can be used as an alternative therapeutic option for sudden hearing loss.
Being with a long period of clinical experience and evidence-based curative effect, acupuncture could be applied as an adjunctive treatment for the sudden hearing loss. Currently, this patient-centered, pragmatic clinical trial compares the effectiveness of using west medicine、combination of west medicine and traditional Chinese medicine. The aim of this study is to explore acceptable and beneficial strategy to reduce the clinical symptoms, to improve quality of life, and decrease medical expenses.
Detailed description
Patients newly diagnosed with sudden deafness were randomly assigned in a 1:1 ratio to two groups: a Western medicine group and an integrated Chinese and Western medicine treatment group. Each group included 32 patients, for a total of 64 patients. Treatment lasted four weeks, starting from the date of admission, and included both inpatient and outpatient care.
Western Medicine Treatment: During hospitalization, intravenous steroids were administered. After discharge, oral steroids were administered. For patients who did not respond well to treatment, intratympanic steroid injections were performed.
Traditional Chinese Medicine Treatment: Acupuncture was performed once daily for 30 minutes at acupoints around the ear and upper limb on the same side as the affected ear. Six treatment sessions were performed in the first and second weeks, and two sessions were performed in the third and fourth weeks.
Primary Outcome: Pure-tone audiograms were performed at baseline, week 1, week 2, and week 4.
Secondary Outcome: Tinnitus Handicap Inventory and Dizziness Handicap Inventory were performed at baseline, week 1, week 2, and week 4. Blood biochemistry tests were performed at baseline. Adverse events were recorded throughout the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Steroid therapy combined with acupuncture | Experimental | Device: AcupunctureWestern Medicine Treatment: During hospitalization, intravenous steroids were administered. After discharge, oral steroids were administered. For patients who did not respond well to treatment, intratympanic steroid injections were performed. Traditional Chinese Medicine Treatment: Acupuncture was performed once daily for 30 minutes at acupoints around the ear and upper limb on the same side as the affected ear. Six treatment sessions were performed in the first and second weeks, and two sessions were performed in the third and fourth weeks. |
| Steroid therapy | Active comparator | Drug: steroid therapyWestern Medicine Treatment: During hospitalization, intravenous steroids were administered. After discharge, oral steroids were administered. For patients who did not respond well to treatment, intratympanic steroid injections were performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years, both male and female.
- Meeting the diagnostic criteria for sudden sensorineural hearing loss (SSNHL), defined as hearing loss of >30 dB affecting at least three consecutive frequencies within 3 days.
- Newly onset of hearing loss within 2 week.
- Fully understanding the purpose and procedures of the study and providing signed informed consent.
Key exclusion criteria (6 listed)
- Central nervous system lesions such as vestibular schwannoma or traumatic brain injury.
- Middle ear or retrocochlear pathology.
- History of otologic surgery.
- Hemorrhagic disorders or coagulation abnormalities.
- Inability to cooperate with examinations due to dementia or psychiatric illness.
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 |
|---|---|---|
| AcupunctureTreatment lasted four weeks, starting from the date of admission, and included both inpatient and outpatient care. Western Medicine Treatment : During hospitalization, intravenous steroids were administered. After discharge, oral steroids were administered. For patients who did not respond well to treatment, intratympanic steroid injections were performed. Traditional Chinese Medicine Treatment : Acupuncture was performed on peri-auricular and ipsilateral upper limb points, including Ermen (TE21), Tinggong (SI19), Tinghui (GB2), Shuaigu (GB8), Yifeng (TE17), Waiguan (TE5), and Zhongzhu (TE3). The treatment was administered once daily for 30 minutes. During the first and second weeks, a total of six sessions were carried out, followed by two sessions per week in the third and fourth weeks. | Device | Steroid therapy combined with acupuncture |
| steroid therapyTreatment lasted four weeks, starting from the date of admission, and included both inpatient and outpatient care. Western Medicine Treatment : During hospitalization, intravenous steroids were administered. After discharge, oral steroids were administered. For patients who did not respond well to treatment, intratympanic steroid injections were performed. | Drug | Steroid therapy |
Primary outcome
Pure-tone audiograms
Time frame: baseline, week 1, week 2, and week 4
Changes from baseline to week 1, week 2, and week 4 of the intervention
5 secondary outcomes
Tinnitus Handicap Inventory
Time frame: baseline, week 1, week 2, and week 4
Dizziness Handicap Inventory
Time frame: baseline, week 1, week 2, and week 4
Blood examination
Time frame: baseline
Laboratory examination
Time frame: baseline
Adverse events
Time frame: baseline, week 1, week 2, and week 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Individual participant dataSharing planned: No
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Efficacy and Safety of Intracochlear Injection of Glucocorticoid Through the Round Window Membrane in Patients With Profound or Complete Sudden Sensorineural Hearing Loss
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Comparison of the Effectiveness of Oral and Intratympanic Corticosteroid Treatments in Patients Diagnosed With Sudden Sensorineural Hearing Loss
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Not yet recruiting
CGM-guided Patch Pump vs Basal-Bolus Injection for Steroid-Induced Hyperglycemia in Sudden Sensorineural Hearing Loss: SHIP Trial
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture and steroid therapy in people with Sudden Hearing Loss, run by China Medical University Hospital at 1 site in Taiwan.
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 4 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: looking for participants now, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ming-Cheng Huang, M.D., Ph.D. (+886-4-22052121 Ext. 14561, mchuang1128@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pure-tone audiograms (time frame: baseline, week 1, week 2, and week 4). 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 19 Nov 2025.