Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07575334

Acupuncture Therapy for Sudden Sensorineural Hearing Loss

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

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eye and ENT Hospital of Fudan University

Shanghai, China

Location status: Recruiting

Location contact

Weiming Hao, MD

CONTACT

[email protected]

86-18017321721

Yan Chen, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.).

Treatment and study plan

Acupuncture

Procedure

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 acupuncture

Procedure

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Hearing outcomes at multiple time points

    Time frame: week 1, 2, 4, 8, and 12

    Changes in PTA at weeks 1, 2, 4, 8, and 12

  2. Word Recognition Score (WRS)

    Time frame: weeks 1, 2, 4, 8, and 12

    Changes of WRS from baseline at weeks 1, 2, 4, 8, and 12

  3. Sudden hearing loss recovery grade

    Time frame: weeks 1, 2, 4, 8, and 12

    Complete, significant, partial, or no recovery according to the 2019 AAO-HNS guideline criteria

  4. TCM symptom score

    Time frame: week 8

    Change from baseline to week 8 using the pattern-specific TCM symptom scale

  5. Sensory Organization Test

    Time frame: weeks 1, 2, 4, 8, and 12

    Sensory Organization Test (SOT) scores at weeks 1, 2, 4, 8, and 12

  6. Insomnia Severity Index (ISI)

    Time frame: weeks 1, 2, 4, 8, and 12

    Changes from baseline at weeks 1, 2, 4, 8, and 12

  7. Dizziness Handicap Inventory (DHI)

    Time frame: weeks 1, 2, 4, 8, and 12

    Changes from baseline at weeks 1, 2, 4, 8, and 12

  8. Tinnitus Handicap Inventory (THI)

    Time frame: weeks 1, 2, 4, 8, and 12

    Changes from baseline at weeks 1, 2, 4, 8, and 12

  9. Hospital Anxiety and Depression Scale (HADS)

    Time frame: weeks 1, 2, 4, 8, and 12

    Changes from baseline at weeks 1, 2, 4, 8, and 12

  10. Quality of life (SF-36)

    Time frame: weeks 1, 2, 4, 8, and 12

    Changes from baseline at weeks 1, 2, 4, 8, and 12

  11. Aural fullness scale (AFS)

    Time frame: weeks 1, 2, 4, 8, and 12

    Visual analog scale (0-10) changes from baseline at weeks 1, 2, 4, 8, and 12

  12. Salvage treatment rate

    Time frame: day 14

    Proportion of participants requiring intratympanic steroid injection due to insufficient hearing recovery at day 14

  13. Safety outcome

    Time frame: week 8

    Proportion of adverse events in both groups at week 8

Study contacts

Contact information is provided by the study sponsor or research team.

Weiming Hao, MD, Doctor

CONTACT

[email protected]

86-18017321721

Sponsors and collaborators

Lead sponsor

Eye & ENT Hospital of Fudan University

Other

Registry information

Official study title

Acupuncture Combined With Glucocorticoids Therapy for Sudden Sensorineural Hearing Loss:A Multicenter Randomized Controlled Clinical Trial

Acronym: SSNHL-Acu

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 8, 2026
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.