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

3 de mayo de 2026 actualizado por: 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.

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Estimado)

256

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Weiming Hao, MD, Doctor
  • Número de teléfono: 86-18017321721
  • Correo electrónico: haoweiming1993@163.com

Ubicaciones de estudio

      • Shanghai, Porcelana
        • Reclutamiento
        • Eye and ENT Hospital of Fudan University
        • Contacto:
        • Investigador principal:
          • Yan Chen, PhD

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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.).

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Triple

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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)

Comparador falso: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Hearing improvement
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Hearing outcomes at multiple time points
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: week 8
Change from baseline to week 8 using the pattern-specific TCM symptom scale
week 8
Sensory Organization Test
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: day 14
Proportion of participants requiring intratympanic steroid injection due to insufficient hearing recovery at day 14
day 14
Safety outcome
Periodo de tiempo: week 8
Proportion of adverse events in both groups at week 8
week 8

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

13 de abril de 2026

Finalización primaria (Estimado)

31 de diciembre de 2027

Finalización del estudio (Estimado)

31 de diciembre de 2027

Fechas de registro del estudio

Enviado por primera vez

3 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

3 de mayo de 2026

Publicado por primera vez (Actual)

8 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

8 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

3 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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