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- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Weiming Hao, MD, Doctor
- Numero di telefono: 86-18017321721
- Email: haoweiming1993@163.com
Luoghi di studio
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Shanghai, Cina
- Reclutamento
- Eye and ENT Hospital of Fudan University
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Contatto:
- Weiming Hao, MD
- Numero di telefono: 86-18017321721
- Email: haoweiming1993@163.com
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Investigatore principale:
- Yan Chen, PhD
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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.).
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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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Comparatore fittizio: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Hearing improvement
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Hearing outcomes at multiple time points
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Manifestazioni neurologiche
- Malattie del sistema nervoso
- Malattie otorinolaringoiatriche
- Disturbi della sensibilità
- Malattie dell'orecchio
- Perdita dell'udito
- Disturbi dell'udito
- Condizioni patologiche, segni e sintomi
- Segni e sintomi
- Perdita dell'udito, improvvisa
- Terapie
- Terapie complementari
- Terapia di agopuntura
Altri numeri di identificazione dello studio
- SSHNL-Acupuncture-Trial
Piano per i dati dei singoli partecipanti (IPD)
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Informazioni su farmaci e dispositivi, documenti di studio
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