Hearing Loss, SuddenNCT04129983
Treatment of Sudden Deafness With Prednisone+Hyperbaric Oxygen and Prednisone+Somatosensory Stimulation
A study testing Drugs and Stimulation in people with Hearing Loss, Sudden and Prednisone Acetate, run by Dan Su at 1 site in China.
Trial summary
To study the effective treatment of sudden deafness by giving prednisone, hyperbaric oxygen and somatosensory stimulation to sudden deafness patients. Read more about this study
- Who is it for?
- Ages 14 to 80 years
- Conditions the study is for
- Hearing Loss, Sudden, Prednisone Acetate, Hyperbaric Oxygen
- What is being tested?
- Drugs and Stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Jun 2020to Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Sudden deafness
- History within 2 months
- Age 14-80
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
E.N.T. department of the First Affiliated hospital of Anhui Medical University
Hefei, Anhui, 230000
About this study
Official title: Prospective Study of Sudden Deafness
To study the effective treatment of sudden deafness by giving prednisone, hyperbaric oxygen and somatosensory stimulation to sudden deafness patients.
Read the 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.
- Being tested
- Drugs and Stimulation
- Keywords
- Hearing Loss, Sudden, Prednisone acetate, Hyperbaric oxygen, Somatic stimulus
- Medical subject headings
- Hearing Loss, Sudden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drugs and StimulationCombination 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.
| Study group | Role | What they receive |
|---|---|---|
| Prednisone acetate + somatosensory stimulation | Experimental | Prednisone acetate 1 mg/kg body weight * 7 days and somatosensory stimulation 30 days were given to sudden deafness patients. Receives: Combination Product: Drugs and Stimulation |
| Prednisone acetate + hyperbaric oxygen | Experimental | Prednisone acetate 1mg / kg body weight * 7 days and hyperbaric oxygen 15 days were given to sudden deafness patients. Receives: Combination Product: Drugs and Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Audiometry
Evaluate the patient's hearing to determine whether it has improved.
Measured: 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
Measured: When patients are enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2019
- Study startJun 2020 (estimated)
- Primary completionJul 2020 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Loss, SuddenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dan Su
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dan Su, The First Affiliated Hospital of Anhui Medical University
- Investigators
- Busheng Tong, doctor, Study director, E.N.T. department of the First Affiliated hospital of Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04129983
- Sponsor's protocol ID
- Pssd
- Status last verified
- Feb 2020
- First submitted
- 14 Oct 2019
- Last updated
- 5 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Sudden Deafness
- ClinicalTrials.gov ID
- NCT04129983
- Acronym / sponsor ID
- Pssd
- Keywords
- Hearing Loss, Sudden, Prednisone acetate, Hyperbaric oxygen, Somatic stimulus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Dan SuUniversity, hospital or other
- Study start
- Jun 2020 (estimated)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 17 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prednisone acetate + somatosensory stimulation | Experimental | Combination Product: Drugs and StimulationPrednisone acetate 1 mg/kg body weight * 7 days and somatosensory stimulation 30 days were given to sudden deafness patients. |
| Prednisone acetate + hyperbaric oxygen | Experimental | Combination Product: Drugs and StimulationPrednisone acetate 1mg / kg body weight * 7 days and hyperbaric oxygen 15 days were given to sudden deafness patients. |
Who may qualify
- Ages
- 14 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Sudden deafness
- History within 2 months
- Age 14-80
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drugs and Stimulation60 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. | Combination product | Prednisone acetate + hyperbaric oxygen, Prednisone acetate + somatosensory stimulation |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Busheng Tong, doctor study director
E.N.T. department of the First Affiliated hospital of Anhui Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drugs and Stimulation in people with Hearing Loss, Sudden and Prednisone Acetate, run by Dan Su at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dan Su, master (+8615755149100, sudan19966991@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Audiometry (time frame: Three months from the patient's selection to the end of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.