- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07575334
Acupuncture Therapy for Sudden Sensorineural Hearing Loss (SSNHL-Acu)
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:
- 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Weiming Hao, MD, Doctor
- Telefonnummer: 86-18017321721
- E-mail: haoweiming1993@163.com
Studiesteder
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Shanghai, Kina
- Rekruttering
- Eye and ENT Hospital of Fudan University
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Kontakt:
- Weiming Hao, MD
- Telefonnummer: 86-18017321721
- E-mail: haoweiming1993@163.com
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Ledende efterforsker:
- Yan Chen, PhD
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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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.
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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) |
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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.
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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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Hearing improvement
Tidsramme: Week 8
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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.
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Week 8
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Hearing outcomes at multiple time points
Tidsramme: week 1, 2, 4, 8, and 12
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Changes in PTA at weeks 1, 2, 4, 8, and 12
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week 1, 2, 4, 8, and 12
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Word Recognition Score (WRS)
Tidsramme: weeks 1, 2, 4, 8, and 12
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Changes of WRS from baseline at weeks 1, 2, 4, 8, and 12
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weeks 1, 2, 4, 8, and 12
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Sudden hearing loss recovery grade
Tidsramme: weeks 1, 2, 4, 8, and 12
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Complete, significant, partial, or no recovery according to the 2019 AAO-HNS guideline criteria
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weeks 1, 2, 4, 8, and 12
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TCM symptom score
Tidsramme: week 8
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Change from baseline to week 8 using the pattern-specific TCM symptom scale
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week 8
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Sensory Organization Test
Tidsramme: weeks 1, 2, 4, 8, and 12
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Sensory Organization Test (SOT) scores at weeks 1, 2, 4, 8, and 12
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weeks 1, 2, 4, 8, and 12
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Insomnia Severity Index (ISI)
Tidsramme: weeks 1, 2, 4, 8, and 12
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Changes from baseline at weeks 1, 2, 4, 8, and 12
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weeks 1, 2, 4, 8, and 12
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Dizziness Handicap Inventory (DHI)
Tidsramme: weeks 1, 2, 4, 8, and 12
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Changes from baseline at weeks 1, 2, 4, 8, and 12
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weeks 1, 2, 4, 8, and 12
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Tinnitus Handicap Inventory (THI)
Tidsramme: weeks 1, 2, 4, 8, and 12
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Changes from baseline at weeks 1, 2, 4, 8, and 12
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weeks 1, 2, 4, 8, and 12
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Hospital Anxiety and Depression Scale (HADS)
Tidsramme: weeks 1, 2, 4, 8, and 12
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Changes from baseline at weeks 1, 2, 4, 8, and 12
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weeks 1, 2, 4, 8, and 12
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Quality of life (SF-36)
Tidsramme: weeks 1, 2, 4, 8, and 12
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Changes from baseline at weeks 1, 2, 4, 8, and 12
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weeks 1, 2, 4, 8, and 12
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Aural fullness scale (AFS)
Tidsramme: weeks 1, 2, 4, 8, and 12
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Visual analog scale (0-10) changes from baseline at weeks 1, 2, 4, 8, and 12
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weeks 1, 2, 4, 8, and 12
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Salvage treatment rate
Tidsramme: day 14
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Proportion of participants requiring intratympanic steroid injection due to insufficient hearing recovery at day 14
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day 14
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Safety outcome
Tidsramme: week 8
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Proportion of adverse events in both groups at week 8
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week 8
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Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- SSHNL-Acupuncture-Trial
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