Treatment of Sudden Deafness With Prednisone+Hyperbaric Oxygen and Prednisone+Somatosensory Stimulation
Prospective Study of Sudden Deafness
1 other identifier
interventional
60
1 country
1
Brief Summary
To study the effective treatment of sudden deafness by giving prednisone, hyperbaric oxygen and somatosensory stimulation to sudden deafness patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 14, 2019
CompletedFirst Posted
Study publicly available on registry
October 17, 2019
CompletedStudy Start
First participant enrolled
June 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2020
CompletedFebruary 5, 2020
February 1, 2020
1 month
October 14, 2019
February 4, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Audiometry
Evaluate the patient's hearing to determine whether it has improved.
Three months from the patient's selection to the end of treatment
Cranial magnetic resonance imaging
Judging whether the patient's inner ear has pathological changes or not
When patients are enrolled
Study Arms (2)
Prednisone acetate + somatosensory stimulation
EXPERIMENTALPrednisone acetate 1 mg/kg body weight \* 7 days and somatosensory stimulation 30 days were given to sudden deafness patients.
Prednisone acetate + hyperbaric oxygen
EXPERIMENTALPrednisone acetate 1mg / kg body weight \* 7 days and hyperbaric oxygen 15 days were given to sudden deafness patients.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Sudden deafness
- History within 2 months
- Age 14-80
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dan Sulead
Study Sites (1)
E.N.T. department of the First Affiliated hospital of Anhui Medical University
Hefei, Anhui, 230000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Busheng Tong, doctor
E.N.T. department of the First Affiliated hospital of Anhui Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
October 14, 2019
First Posted
October 17, 2019
Study Start
June 1, 2020
Primary Completion
July 1, 2020
Study Completion
October 1, 2020
Last Updated
February 5, 2020
Record last verified: 2020-02