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

NCT ID: NCT04129983

Last Updated: 2020-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-30

Study Completion Date

2020-10-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Hearing Loss, Sudden Prednisone Acetate Hyperbaric Oxygen Somatic Stimulus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Prednisone acetate + somatosensory stimulation

Prednisone acetate 1 mg/kg body weight \* 7 days and somatosensory stimulation 30 days were given to sudden deafness patients.

Group Type EXPERIMENTAL

Drugs and Stimulation

Intervention Type COMBINATION_PRODUCT

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.

Prednisone acetate + hyperbaric oxygen

Prednisone acetate 1mg / kg body weight \* 7 days and hyperbaric oxygen 15 days were given to sudden deafness patients.

Group Type EXPERIMENTAL

Drugs and Stimulation

Intervention Type COMBINATION_PRODUCT

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.

Interventions

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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.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dan Su

OTHER

Sponsor Role lead

Responsible Party

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Dan Su

principal investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Busheng Tong, doctor

Role: STUDY_DIRECTOR

E.N.T. department of the First Affiliated hospital of Anhui Medical University

Locations

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E.N.T. department of the First Affiliated hospital of Anhui Medical University

Hefei, Anhui, China

Site Status

Countries

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China

Central Contacts

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Dan Su, master

Role: CONTACT

+8615755149100

Busheng Tong, doctor

Role: CONTACT

+8613956040273

Other Identifiers

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Pssd

Identifier Type: -

Identifier Source: org_study_id

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