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

Hearing Loss, Sudden Clinical Trial

Official title:

Prospective Study of Sudden Deafness

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04129983
• Other study ID #: Pssd
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2020
• Est. completion date: October 2020

Study information

• Verified date: February 2020
• Source: The First Affiliated Hospital of Anhui Medical University
• Contact: Dan Su, master
• Phone: +8615755149100
• Email: sudan19966991[@]outlook.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: October 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Hearing Loss, Sudden
• Hyperbaric Oxygen
• Prednisone Acetate
• Somatic Stimulus

Intervention

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.

Locations

Country	Name	City	State
China	E.N.T. department of the First Affiliated hospital of Anhui Medical University	Hefei	Anhui

Sponsors (1)

Lead Sponsor	Collaborator
Dan Su

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Audiometry	Evaluate the patient's hearing to determine whether it has improved.	Three months from the patient's selection to the end of treatment
Primary	Cranial magnetic resonance imaging	Judging whether the patient's inner ear has pathological changes or not	When patients are enrolled