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Clinical Efficacy Observation of Acupuncture Combined with Intratympanic Injection of Dexamethasone in the Treatment of Sudden Hearing Loss

Clinical Efficacy Observation of Acupuncture Combined with Intratympanic Injection of Dexamethasone in the Treatment of Sudden Hearing Loss

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400082916
Enrollment
Unknown
Registered
2024-04-10
Start date
2024-04-10
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sudden sensorineural hearing loss

Interventions

Experiment Group 1 (Experiment Group):Acupuncture combined with intratympanic injection of dexamethasone
Experiment Group 2 (Control Group):Sham acupuncture combined with intratympanic injection of dexamethasone

Sponsors

Eye and ENT Hospital of Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients regardless of gender, aged 18-65 years (inclusive); 2. Unilateral hearing loss patients diagnosed with sudden sensorineural hearing loss in accordance with the American Association of Otolaryngology Head and Neck Surgeons (AAO-HNS) diagnosis and treatment guidelines, with idiopathic hearing loss (diagnostic criteria: sensorineural hearing loss that occurs suddenly within 72 hours and of unknown cause, with a hearing loss of = 30dB in at least three adjacent frequencies of 0.5KHz/1KHz/2KHz/4KHz) (on the day of enrollment); 3. Patients within 14 days of onset; 4. The patient has unilateral onset of the disease and has a history of symmetrical hearing in both ears.

Exclusion criteria

Exclusion criteria: 1. Patients with a history of hearing abnormalities in the affected ear or the opposite ear; 2. Patients with concomitant diseases of the inner ear, such as Meniere's disease, vestibular neuritis, labyrinthitis, otosclerosis, benign paroxysmal positional vertigo, vestibular aqueduct enlargement, Mondini malformation, inner ear tumors, etc; 3. Patients with contraindications to intratympanic glucocorticoid injection; 4. Patients who have received glucocorticoid therapy within 14 days of onset; 5. Women who are breastfeeding, pregnant, or potentially pregnant; 6. Patients with severe cervical spondylosis, fractures, mental disorders, and other illnesses; 7. Patients who are unable to cooperate with medication and examinations; 8. Patients who are allergic to the prescribed medication in the plan; 9. Patients who have participated in clinical trials of other drugs or devices within the past three months; 10. Patients with skin lesions, scars, etc. at acupoints that affect acupuncture treatment; 11. Other situations deemed unsuitable for this experiment.

Design outcomes

Primary

MeasureTime frame
Pure tone threshold;

Secondary

MeasureTime frame
Word Recognition Score;Tinnitus Handicap Inventory;Quality of Life;Hospital anxiety and depression scale;

Countries

China

Contacts

Public ContactRen Dongdong

Eye and ENT Hospital of Fudan University

dongdongren@fudan.edu.cn+86 138 0191 3332

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 15, 2026