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Clinical Trials/NCT04129983
NCT04129983UnknownNot Applicable

Prospective Study of Sudden Deafness

Dan Su1 site in 1 country60 target enrollmentStarted: June 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
Audiometry

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Care Provider)

Eligibility Criteria

Ages
14 Years to 80 Years (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Dan Su
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Dan Su

principal investigator

The First Affiliated Hospital of Anhui Medical University

Study Sites (1)

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