Treatment of Sudden Deafness With Prednisone+Hyperbaric Oxygen and Prednisone+Somatosensory Stimulation

Overview

To study the effective treatment of sudden deafness by giving prednisone, hyperbaric oxygen and somatosensory stimulation to sudden deafness patients.

Full Title of Study: “Prospective Study of Sudden Deafness”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Care Provider)
  • Study Primary Completion Date: July 2020

Detailed Description

60 cases of sudden deafness within 2 months of 14-80 years old were randomly divided into two groups. They underwent hearing tests, magnetic resonance imaging of the head, and routine hospital admissions. One group was given prednisone for 1 mg / kg body weight × 7 days + somatosensory stimulation × 30 days, the other group was given prednisone for 1 mg / kg body weight × 7 days + hyperbaric oxygen × 15 days, and repeated electrical audiometry every week. One month and three months after the experiment, repeated audiometry.

Interventions

  • Combination Product: Drugs and Stimulation
    • 60 cases of sudden deafness were inquired about their medical history and examined by hearing and cranial magnetic resonance. They were randomly divided into two groups and given different treatments. The hearing test was repeated every 7 days. One month and three months after the treatment, the hearing examination was reexamined.

Arms, Groups and Cohorts

  • Experimental: Prednisone acetate + somatosensory stimulation
    • Prednisone acetate 1 mg/kg body weight * 7 days and somatosensory stimulation 30 days were given to sudden deafness patients.
  • Experimental: Prednisone acetate + hyperbaric oxygen
    • Prednisone acetate 1mg / kg body weight * 7 days and hyperbaric oxygen 15 days were given to sudden deafness patients.

Clinical Trial Outcome Measures

Primary Measures

  • Audiometry
    • Time Frame: Three months from the patient’s selection to the end of treatment
    • Evaluate the patient’s hearing to determine whether it has improved.
  • Cranial magnetic resonance imaging
    • Time Frame: When patients are enrolled
    • Judging whether the patient’s inner ear has pathological changes or not

Participating in This Clinical Trial

Inclusion Criteria

  • Sudden deafness – History within 2 months – Age 14-80 Exclusion Criteria:

  • Neurological diseases (such as brain tumors) – Patients with mental / mental illness undergoing treatment – Pregnant women and patients with other untreatable diseases – Finding the cause of sensorineural deafness – Patients Not Suitable for Hyperbaric Oxygen – A patient with dermatosis

Gender Eligibility: All

Minimum Age: 14 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Dan Su
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Dan Su, principal investigator – The First Affiliated Hospital of Anhui Medical University
  • Overall Official(s)
    • Busheng Tong, doctor, Study Director, E.N.T. department of the First Affiliated hospital of Anhui Medical University
  • Overall Contact(s)
    • Dan Su, master, +8615755149100, sudan19966991@outlook.com

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