Back to resultsTreatment of Sudden Deafness With Prednisone+Hyperbaric Oxygen and Prednisone+Somatosensory Stimulation
Primary Purpose
Hearing Loss, Sudden, Prednisone Acetate, Hyperbaric Oxygen
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Drugs and Stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Hearing Loss, Sudden focused on measuring Hearing Loss, Sudden, Prednisone acetate, Hyperbaric oxygen, Somatic stimulus
Eligibility Criteria
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
Sites / Locations
- E.N.T. department of the First Affiliated hospital of Anhui Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Prednisone acetate + somatosensory stimulation
Prednisone acetate + hyperbaric oxygen
Arm Description
Prednisone acetate 1 mg/kg body weight * 7 days and somatosensory stimulation 30 days were given to sudden deafness patients.
Prednisone acetate 1mg / kg body weight * 7 days and hyperbaric oxygen 15 days were given to sudden deafness patients.
Outcomes
Primary Outcome Measures
Audiometry
Evaluate the patient's hearing to determine whether it has improved.
Cranial magnetic resonance imaging
Judging whether the patient's inner ear has pathological changes or not
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04129983
Brief Title
Treatment of Sudden Deafness With Prednisone+Hyperbaric Oxygen and Prednisone+Somatosensory Stimulation
Official Title
Prospective Study of Sudden Deafness
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 2020 (Anticipated)
Primary Completion Date
July 2020 (Anticipated)
Study Completion Date
October 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dan Su
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Sudden, Prednisone Acetate, Hyperbaric Oxygen, Somatic Stimulus
Keywords
Hearing Loss, Sudden, Prednisone acetate, Hyperbaric oxygen, Somatic stimulus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Prednisone acetate + somatosensory stimulation
Arm Type
Experimental
Arm Description
Prednisone acetate 1 mg/kg body weight * 7 days and somatosensory stimulation 30 days were given to sudden deafness patients.
Arm Title
Prednisone acetate + hyperbaric oxygen
Arm Type
Experimental
Arm Description
Prednisone acetate 1mg / kg body weight * 7 days and hyperbaric oxygen 15 days were given to sudden deafness patients.
Intervention Type
Combination Product
Intervention Name(s)
Drugs and Stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Audiometry
Description
Evaluate the patient's hearing to determine whether it has improved.
Time Frame
Three months from the patient's selection to the end of treatment
Title
Cranial magnetic resonance imaging
Description
Judging whether the patient's inner ear has pathological changes or not
Time Frame
When patients are enrolled
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dan Su, master
Phone
+8615755149100
Email
sudan19966991@outlook.com
First Name & Middle Initial & Last Name or Official Title & Degree
Busheng Tong, doctor
Phone
+8613956040273
Email
2871638103@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Busheng Tong, doctor
Organizational Affiliation
E.N.T. department of the First Affiliated hospital of Anhui Medical University
Official's Role
Study Director
Facility Information:
Facility Name
E.N.T. department of the First Affiliated hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230000
Country
China
12. IPD Sharing Statement
Learn more about this trial
Treatment of Sudden Deafness With Prednisone+Hyperbaric Oxygen and Prednisone+Somatosensory Stimulation
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