Sudden Sensorineural Hearing Loss (SSNHL)SSNHL-AcuNCT07575334
Acupuncture Therapy for Sudden Sensorineural Hearing Loss
A study testing Acupuncture in people with Sudden Sensorineural Hearing Loss (SSNHL), run by Eye & ENT Hospital of Fudan University at 1 site in China.
Trial summary
The goal of this multicenter, prospective, randomized controlled trial is to evaluate the efficacy and safety of acupuncture combined with corticosteroid therapy in treating sudden sensorineural hearing loss (SSNHL). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Sudden Sensorineural Hearing Loss (SSNHL)
- What is being tested?
- Acupuncture
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 256 participants
- Where
- 1 siteChina
- Study dates
- 13 Apr 2026to 31 Dec 2027
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 70 years;
- Meets the diagnostic criteria for sudden sensorineural hearing loss (SSNHL): sudden, unexplained sensorineural hearing loss occurring within 72 hours, with a hearing threshold decrease of ≥30 dB in at least three consecutive frequencies among 250, 500, 1000, 2000, 4000, and 8000 Hz (reference: previous audiologic examination or same frequencies of the contralateral ear);
- Unilateral SSNHL with self-perceived symmetrical hearing in both ears prior to the current episode (or supported by previous audiologic examination reports);
- Time from symptom onset to enrollment and treatment initiation within 14 days;
- Clear consciousness and logical responses, able to understand the scale items and complete the assessments;
- Agrees to participate in the trial and signs a written informed consent form.
Who cannot join
- Identifiable definite etiology after complete examination, including acoustic neuroma, cerebrovascular accident, trauma, Hunt syndrome, etc.;
- History of hearing abnormality (affected ear) or balance dysfunction prior to the current episode (including previous SSNHL, vestibular migraine, Meniere's disease, benign paroxysmal positional vertigo, congenital/hereditary/syphilitic hearing loss, otosclerosis, etc.);
- Presence of diseases for which systemic corticosteroid therapy is clinically not recommended (e.g., poorly controlled or insulin-dependent diabetes mellitus, history of peptic ulcer, active infection or tuberculosis, history of hepatitis B or C, pancreatitis, severe osteoporosis, osteonecrosis, etc.);
- Received systemic or local corticosteroid therapy for 10 days or more prior to enrollment;
- Presence of other diseases (e.g., severe skin disorders) that preclude completion of acupuncture treatment;
- Presence of severe organ dysfunction;
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- Received acupuncture treatment within the past 12 months;
- Pregnant or breastfeeding women;
- Other reasons deemed by the investigator as unsuitable for participation in this clinical study (e.g., high anticipated difficulty in completing follow-up, obvious low compliance, etc.).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Eye and ENT Hospital of Fudan University
Shanghai
Weiming Hao, MD, 86-18017321721, haoweiming1993@163.com
Yan Chen, PhD
About this study
Official title: Acupuncture Combined With Glucocorticoids Therapy for Sudden Sensorineural Hearing Loss：A Multicenter Randomized Controlled Clinical Trial
The goal of this multicenter, prospective, randomized controlled trial is to evaluate the efficacy and safety of acupuncture combined with corticosteroid therapy in treating sudden sensorineural hearing loss (SSNHL). The main questions it aims to answer are:
Does acupuncture combined with corticosteroids improve hearing recovery (pure tone audiometry, PTA) at 8 weeks compared with sham acupuncture combined with corticosteroids? Does this treatment improve secondary outcomes, including tinnitus, dizziness, sleep quality, anxiety, and quality of life? Researchers will compare acupuncture (experimental group) with sham acupuncture (control group) to determine the added therapeutic effect of acupuncture.
Read more
Participants will:
- Receive either real acupuncture or sham acupuncture 3 times per week for 4 weeks.
- Meanwhile, take oral prednisone (1 mg/kg/day, maximum 60 mg/day) for 7 days followed by a 7-day taper.
- Undergo hearing tests (PTA, word recognition scores), vestibular function tests, and complete validated questionnaires (SF-36, HADS, ISI, DHI, THI, and TCM symptom scales) at baseline and weeks 1, 2, 4, 8, and 12.
- Receive salvage intratympanic steroid injections if hearing does not improve sufficiently by day 14.
- Being tested
- Acupuncture, Sham acupuncture
- Keywords
- acupuncture, Sudden sensorineural hearing loss (SSNHL)
- 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.
AcupunctureProcedure or surgery
Main Acupoints (Fixed): Tinghui (GB2), Yifeng (SJ17), Tinggong (SI19), and Shuaigu (GB8) on the affected side; Baihui (GV20) at the vertex; Zhongzhu (SJ3) and Zulinqi (GB41) bilaterally.
Adjunct Acupoints (Bilateral, selected based on TCM pattern differentiation):
External Pathogen Invasion: Hegu (LI4) + Waiguan (SJ5) Liver Fire Harassing Upper: Yanglingquan (GB34) + Xingjian (LR2) Phlegm Fire Stagnation: Fenglong (ST40) + Neiting (ST44) Qi Stagnation and Blood Stasis: Xuehai (SP10) + Taichong (LR3) Kidney Essence Deficiency: Taixi (KI3) + Sanyinjiao (SP6) Spleen and Stomach Deficiency: Zusanli (ST36) + Qihai (CV6)
Sham acupunctureProcedure or surgery
The same acupoints are used, but with blunt-tip placebo needles that do not penetrate the skin. The needles are fixed with adhesive patches, and the procedure is identical to the real acupuncture group to maintain blinding.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture combined with corticosteroids group | Experimental | Participants in this group will receive real acupuncture 3 times per week for 4 weeks, together with oral prednisone (1 mg/kg/day, maximum 60 mg/day) for 7 days followed by a 7-day taper, plus oral Ginkgo biloba extract for 4 weeks. Receives: Procedure: Acupuncture |
| Sham acupuncture combined with corticosteroids group | Sham comparator | Participants in this group will receive sham acupuncture (applied to the same acupoint locations as in the experimental group, while the needle tip does not penetrate the skin) 3 times per week for 4 weeks, together with oral prednisone (1 mg/kg/day, maximum 60 mg/day) for 7 days followed by a 7-day taper, plus oral Ginkgo biloba extract for 4 weeks. Receives: Procedure: Sham acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hearing improvement
Hearing improvement measured by the change in Pure Tone Audiometry (PTA) average (500, 1000, 2000, and 4000 Hz) from baseline to week 8, compared between the acupuncture + corticosteroid group and the sham acupuncture + corticosteroid group.
Measured: Week 8
Secondary outcomes (13)
Hearing outcomes at multiple time points
Changes in PTA at weeks 1, 2, 4, 8, and 12
Measured: week 1, 2, 4, 8, and 12
Word Recognition Score (WRS)
Changes of WRS from baseline at weeks 1, 2, 4, 8, and 12
Measured: weeks 1, 2, 4, 8, and 12
Sudden hearing loss recovery grade
Complete, significant, partial, or no recovery according to the 2019 AAO-HNS guideline criteria
Measured: weeks 1, 2, 4, 8, and 12
TCM symptom score
Change from baseline to week 8 using the pattern-specific TCM symptom scale
Measured: week 8
Sensory Organization Test
Sensory Organization Test (SOT) scores at weeks 1, 2, 4, 8, and 12
Measured: weeks 1, 2, 4, 8, and 12
Insomnia Severity Index (ISI)
Changes from baseline at weeks 1, 2, 4, 8, and 12
Measured: weeks 1, 2, 4, 8, and 12
Dizziness Handicap Inventory (DHI)
Changes from baseline at weeks 1, 2, 4, 8, and 12
Measured: weeks 1, 2, 4, 8, and 12
Tinnitus Handicap Inventory (THI)
Changes from baseline at weeks 1, 2, 4, 8, and 12
Measured: weeks 1, 2, 4, 8, and 12
Hospital Anxiety and Depression Scale (HADS)
Changes from baseline at weeks 1, 2, 4, 8, and 12
Measured: weeks 1, 2, 4, 8, and 12
Quality of life (SF-36)
Changes from baseline at weeks 1, 2, 4, 8, and 12
Measured: weeks 1, 2, 4, 8, and 12
Aural fullness scale (AFS)
Visual analog scale (0-10) changes from baseline at weeks 1, 2, 4, 8, and 12
Measured: weeks 1, 2, 4, 8, and 12
Salvage treatment rate
Proportion of participants requiring intratympanic steroid injection due to insufficient hearing recovery at day 14
Measured: day 14
Safety outcome
Proportion of adverse events in both groups at week 8
Measured: week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start13 Apr 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sudden Sensorineural Hearing Loss (SSNHL)Studies of the same condition, open and under way.
- 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
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 256 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eye & ENT Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07575334
- Sponsor's protocol ID
- SSHNL-Acupuncture-Trial
- Acronym
- SSNHL-Acu
- Status last verified
- May 2026
- First submitted
- 3 May 2026
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture Combined With Glucocorticoids Therapy for Sudden Sensorineural Hearing Loss：A Multicenter Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07575334
- Acronym / sponsor ID
- SSNHL-Acu / SSHNL-Acupuncture-Trial
- Keywords
- acupuncture, Sudden sensorineural hearing loss (SSNHL)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 13 Apr 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 8 May 2026 (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.
The goal of this multicenter, prospective, randomized controlled trial is to evaluate the efficacy and safety of acupuncture combined with corticosteroid therapy in treating sudden sensorineural hearing loss (SSNHL). The main questions it aims to answer are:
Does acupuncture combined with corticosteroids improve hearing recovery (pure tone audiometry, PTA) at 8 weeks compared with sham acupuncture combined with corticosteroids? Does this treatment improve secondary outcomes, including tinnitus, dizziness, sleep quality, anxiety, and quality of life? Researchers will compare acupuncture (experimental group) with sham acupuncture (control group) to determine the added therapeutic effect of acupuncture.
Participants will:
- Receive either real acupuncture or sham acupuncture 3 times per week for 4 weeks.
- Meanwhile, take oral prednisone (1 mg/kg/day, maximum 60 mg/day) for 7 days followed by a 7-day taper.
- Undergo hearing tests (PTA, word recognition scores), vestibular function tests, and complete validated questionnaires (SF-36, HADS, ISI, DHI, THI, and TCM symptom scales) at baseline and weeks 1, 2, 4, 8, and 12.
- Receive salvage intratympanic steroid injections if hearing does not improve sufficiently by day 14.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture combined with corticosteroids group | Experimental | Procedure: AcupunctureParticipants in this group will receive real acupuncture 3 times per week for 4 weeks, together with oral prednisone (1 mg/kg/day, maximum 60 mg/day) for 7 days followed by a 7-day taper, plus oral Ginkgo biloba extract for 4 weeks. |
| Sham acupuncture combined with corticosteroids group | Sham comparator | Procedure: Sham acupunctureParticipants in this group will receive sham acupuncture (applied to the same acupoint locations as in the experimental group, while the needle tip does not penetrate the skin) 3 times per week for 4 weeks, together with oral prednisone (1 mg/kg/day, maximum 60 mg/day) for 7 days followed by a 7-day taper, plus oral Ginkgo biloba extract for 4 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 18 and 70 years;
- Meets the diagnostic criteria for sudden sensorineural hearing loss (SSNHL): sudden, unexplained sensorineural hearing loss occurring within 72 hours, with a hearing threshold decrease of ≥30 dB in at least three consecutive frequencies among 250, 500, 1000, 2000, 4000, and 8000 Hz (reference: previous audiologic examination or same frequencies of the contralateral ear);
- Unilateral SSNHL with self-perceived symmetrical hearing in both ears prior to the current episode (or supported by previous audiologic examination reports);
- Time from symptom onset to enrollment and treatment initiation within 14 days;
- Clear consciousness and logical responses, able to understand the scale items and complete the assessments;
Key exclusion criteria (9 listed)
- Identifiable definite etiology after complete examination, including acoustic neuroma, cerebrovascular accident, trauma, Hunt syndrome, etc.;
- History of hearing abnormality (affected ear) or balance dysfunction prior to the current episode (including previous SSNHL, vestibular migraine, Meniere's disease, benign paroxysmal positional vertigo, congenital/hereditary/syphilitic hearing loss, otosclerosis, etc.);
- Presence of diseases for which systemic corticosteroid therapy is clinically not recommended (e.g., poorly controlled or insulin-dependent diabetes mellitus, history of peptic ulcer, active infection or tuberculosis, history of hepatitis B or C, pancreatitis, severe osteoporosis, osteonecrosis, etc.);
- Received systemic or local corticosteroid therapy for 10 days or more prior to enrollment;
- Presence of other diseases (e.g., severe skin disorders) that preclude completion of acupuncture treatment;
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 |
|---|---|---|
| AcupunctureMain Acupoints (Fixed): Tinghui (GB2), Yifeng (SJ17), Tinggong (SI19), and Shuaigu (GB8) on the affected side; Baihui (GV20) at the vertex; Zhongzhu (SJ3) and Zulinqi (GB41) bilaterally. Adjunct Acupoints (Bilateral, selected based on TCM pattern differentiation): External Pathogen Invasion: Hegu (LI4) + Waiguan (SJ5) Liver Fire Harassing Upper: Yanglingquan (GB34) + Xingjian (LR2) Phlegm Fire Stagnation: Fenglong (ST40) + Neiting (ST44) Qi Stagnation and Blood Stasis: Xuehai (SP10) + Taichong (LR3) Kidney Essence Deficiency: Taixi (KI3) + Sanyinjiao (SP6) Spleen and Stomach Deficiency: Zusanli (ST36) + Qihai (CV6) | Procedure or surgery | Acupuncture combined with corticosteroids group |
| Sham acupunctureThe same acupoints are used, but with blunt-tip placebo needles that do not penetrate the skin. The needles are fixed with adhesive patches, and the procedure is identical to the real acupuncture group to maintain blinding. | Procedure or surgery | Sham acupuncture combined with corticosteroids group |
Primary outcome
Hearing improvement
Time frame: Week 8
Hearing improvement measured by the change in Pure Tone Audiometry (PTA) average (500, 1000, 2000, and 4000 Hz) from baseline to week 8, compared between the acupuncture + corticosteroid group and the sham acupuncture + corticosteroid group.
13 secondary outcomes
Hearing outcomes at multiple time points
Time frame: week 1, 2, 4, 8, and 12
Word Recognition Score (WRS)
Time frame: weeks 1, 2, 4, 8, and 12
Sudden hearing loss recovery grade
Time frame: weeks 1, 2, 4, 8, and 12
TCM symptom score
Time frame: week 8
Sensory Organization Test
Time frame: weeks 1, 2, 4, 8, and 12
Insomnia Severity Index (ISI)
Time frame: weeks 1, 2, 4, 8, and 12
Dizziness Handicap Inventory (DHI)
Time frame: weeks 1, 2, 4, 8, and 12
Tinnitus Handicap Inventory (THI)
Time frame: weeks 1, 2, 4, 8, and 12
Hospital Anxiety and Depression Scale (HADS)
Time frame: weeks 1, 2, 4, 8, and 12
Quality of life (SF-36)
Time frame: weeks 1, 2, 4, 8, and 12
Aural fullness scale (AFS)
Time frame: weeks 1, 2, 4, 8, and 12
Salvage treatment rate
Time frame: day 14
Safety outcome
Time frame: week 8
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 8 May 2026.
- Individual participant dataSharing planned: Undecided
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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 in people with Sudden Sensorineural Hearing Loss (SSNHL), run by Eye & ENT Hospital of Fudan University at 1 site in China.
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 6 inclusion and 9 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 8 May 2026. 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 China. 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. Some participants in this study may receive a placebo. 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 Weiming Hao, MD, Doctor (86-18017321721, haoweiming1993@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hearing improvement (time frame: Week 8). 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 8 May 2026.