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Acupuncture Therapy for Sudden Sensorineural Hearing Loss (SSNHL-Acu)

3. maj 2026 opdateret af: Eye & ENT Hospital of Fudan University

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.

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.

Studieoversigt

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

256

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

      • Shanghai, Kina
        • Rekruttering
        • Eye and ENT Hospital of Fudan University
        • Kontakt:
        • Ledende efterforsker:
          • Yan Chen, PhD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.).

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Acupuncture combined with corticosteroids group
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.

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-komparator: Sham acupuncture combined with corticosteroids group
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.
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Hearing improvement
Tidsramme: 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.
Week 8

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Hearing outcomes at multiple time points
Tidsramme: week 1, 2, 4, 8, and 12
Changes in PTA at weeks 1, 2, 4, 8, and 12
week 1, 2, 4, 8, and 12
Word Recognition Score (WRS)
Tidsramme: weeks 1, 2, 4, 8, and 12
Changes of WRS from baseline at weeks 1, 2, 4, 8, and 12
weeks 1, 2, 4, 8, and 12
Sudden hearing loss recovery grade
Tidsramme: weeks 1, 2, 4, 8, and 12
Complete, significant, partial, or no recovery according to the 2019 AAO-HNS guideline criteria
weeks 1, 2, 4, 8, and 12
TCM symptom score
Tidsramme: week 8
Change from baseline to week 8 using the pattern-specific TCM symptom scale
week 8
Sensory Organization Test
Tidsramme: weeks 1, 2, 4, 8, and 12
Sensory Organization Test (SOT) scores at weeks 1, 2, 4, 8, and 12
weeks 1, 2, 4, 8, and 12
Insomnia Severity Index (ISI)
Tidsramme: weeks 1, 2, 4, 8, and 12
Changes from baseline at weeks 1, 2, 4, 8, and 12
weeks 1, 2, 4, 8, and 12
Dizziness Handicap Inventory (DHI)
Tidsramme: weeks 1, 2, 4, 8, and 12
Changes from baseline at weeks 1, 2, 4, 8, and 12
weeks 1, 2, 4, 8, and 12
Tinnitus Handicap Inventory (THI)
Tidsramme: weeks 1, 2, 4, 8, and 12
Changes from baseline at weeks 1, 2, 4, 8, and 12
weeks 1, 2, 4, 8, and 12
Hospital Anxiety and Depression Scale (HADS)
Tidsramme: weeks 1, 2, 4, 8, and 12
Changes from baseline at weeks 1, 2, 4, 8, and 12
weeks 1, 2, 4, 8, and 12
Quality of life (SF-36)
Tidsramme: weeks 1, 2, 4, 8, and 12
Changes from baseline at weeks 1, 2, 4, 8, and 12
weeks 1, 2, 4, 8, and 12
Aural fullness scale (AFS)
Tidsramme: weeks 1, 2, 4, 8, and 12
Visual analog scale (0-10) changes from baseline at weeks 1, 2, 4, 8, and 12
weeks 1, 2, 4, 8, and 12
Salvage treatment rate
Tidsramme: day 14
Proportion of participants requiring intratympanic steroid injection due to insufficient hearing recovery at day 14
day 14
Safety outcome
Tidsramme: week 8
Proportion of adverse events in both groups at week 8
week 8

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

13. april 2026

Primær færdiggørelse (Anslået)

31. december 2027

Studieafslutning (Anslået)

31. december 2027

Datoer for studieregistrering

Først indsendt

3. maj 2026

Først indsendt, der opfyldte QC-kriterier

3. maj 2026

Først opslået (Faktiske)

8. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. maj 2026

Sidst verificeret

1. maj 2026

Mere information

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