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

Not Applicable

• Conditions: Somatic Stimulus; Prednisone Acetate; Hearing Loss, Sudden; Hyperbaric Oxygen
• Interventions: Combination Product: Drugs and Stimulation

• Registration Number: NCT04129983
• Lead Sponsor: Dan Su

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2019-10-14
• Study First Submitted QC: 2019-10-15
• Study First Posted: 2019-10-17
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-04
• Last Update Posted: 2020-02-05
• Study Start: 2020-06
• Primary Completion: 2020-07
• Study Completion: 2020-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prednisone acetate + somatosensory stimulation	Drugs and Stimulation	Prednisone acetate 1 mg/kg body weight \* 7 days and somatosensory stimulation 30 days were given to sudden deafness patients.
Prednisone acetate + hyperbaric oxygen	Drugs and Stimulation	Prednisone acetate 1mg / kg body weight \* 7 days and hyperbaric oxygen 15 days were given to sudden deafness patients.

Primary Outcome Measures

Name	Time	Method
Audiometry	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	When patients are enrolled	Judging whether the patient's inner ear has pathological changes or not

Trial Locations

Locations (1)

E.N.T. department of the First Affiliated hospital of Anhui Medical University; 🇨🇳 Hefei, Anhui, China