NCT07575334

Brief 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). 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:

  1. 1.Receive either real acupuncture or sham acupuncture 3 times per week for 4 weeks.
  2. 2.Meanwhile, take oral prednisone (1 mg/kg/day, maximum 60 mg/day) for 7 days followed by a 7-day taper.
  3. 3.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.
  4. 4.Receive salvage intratympanic steroid injections if hearing does not improve sufficiently by day 14.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
256

participants targeted

Target at P75+ for not_applicable

Timeline
20mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress4%
Apr 2026Dec 2027

Study Start

First participant enrolled

April 13, 2026

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

May 3, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 8, 2026

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

May 8, 2026

Status Verified

May 1, 2026

Enrollment Period

1.7 years

First QC Date

May 3, 2026

Last Update Submit

May 3, 2026

Conditions

Sudden Sensorineural Hearing Loss (SSNHL)

Keywords

acupunctureSudden sensorineural hearing loss (SSNHL)

Outcome Measures

Primary Outcomes (1)

  • 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.

    Week 8

Secondary Outcomes (13)

  • Hearing outcomes at multiple time points

    week 1, 2, 4, 8, and 12

  • Word Recognition Score (WRS)

    weeks 1, 2, 4, 8, and 12

  • Sudden hearing loss recovery grade

    weeks 1, 2, 4, 8, and 12

  • TCM symptom score

    week 8

  • Sensory Organization Test

    weeks 1, 2, 4, 8, and 12

  • +8 more secondary outcomes

Study Arms (2)

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.

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.

Procedure: Sham acupuncture

Interventions

AcupuncturePROCEDURE

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)

Acupuncture combined with corticosteroids group
Sham acupuncturePROCEDURE

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.

Sham acupuncture combined with corticosteroids group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • 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.).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eye and ENT Hospital of Fudan University

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Hearing Loss, Sudden

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Hearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Central Study Contacts

Weiming Hao, MD, Doctor

CONTACT

86-18017321721haoweiming1993@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2026

First Posted

May 8, 2026

Study Start

April 13, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

May 8, 2026

Record last verified: 2026-05

Locations

CN(1)