Vestibular VertigoNCT03974867
Vestibular Prognosis Assessment of ISSNHL With Vestibular Dysfunction Treated With Oral or Intratympanic Glucocorticoids
A study testing Prednisone 5Mg Tab and Methylprednisolone 40 mg in people with Vestibular Vertigo and Sudden Hearing Loss, run by Eye & ENT Hospital of Fudan University at 1 site in China.
Trial summary
Idiopathic sudden sensorineural hearing loss (ISSNHL) is a complicated hearing impairment with unclear etiology and unsatisfying treatment effects. Vestibular dysfunction like vertigo has been considered as a risk factor of profound hearing loss and poor prognosis in ISSNHL. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Vestibular Vertigo, Sudden Hearing Loss
- What is being tested?
- Prednisone 5Mg Tab and Methylprednisolone 40 mg
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- Jul 2019to Dec 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged between 18 to 70 years old;
- Diagnosed with unilateral ISSNHL according to the National Institute for Deafness and Communication Disorders (NICDC) criteria30: a decrease in hearing of ≥30 decibels (dB), affecting at least 3 consecutive frequencies occurring within a 72-hour period. Since premorbid audiometry is generally unavailable, premorbid hearing level will be defined as the opposite ear's thresholds in this condition;
- Reported vertigo/dizziness/imbalance/lateropulsion and abnormal results in at least one of the vestibular function tests (including SOT, caloric test, vHIT, cVEMP, and oVEMP);
- Onset of audio-vestibular symptoms occurred within 7 days;
- Be willing to sign the informed consent of the study.
Who cannot join
- Definite etiologies are found or highly suspected after clinical evaluations, such as vestibular schwannoma, stroke, trauma or demyelinating disease;
- Diagnosed with a present or previous hearing or balance disorders which might be confused with ISSNHL (history of Meniere's disease, benign paroxysmal positional vertigo, vestibular neuronitis or vestibular migraine; history of otosclerosis; history of luetic, congenital or genetic hearing loss, etc.);
- Hearing level (evaluated with PTA) in the unaffected ear is abnormal, so that a premorbid hearing level of the affected ear may not be estimated;
- Suspected as central vestibular dysfunction, evaluated by present and previous medical history, physical examination and VNG;
- Present with conditions contraindicated systemic glucocorticoids use, such as tuberculosis, hepatitis C or B infection, active herpes zoster infection or other known human immunodeficiency virus, pancreatitis, insulin-dependent diabetes mellitus, severe osteoporosis, chronic renal insufficiency or gastrointestinal ulcer;
- A history of more than 3 days sufficient systemic glucocorticoids uses (≥1 mg/kg/d) within 3 months which may increase the risk of adverse effects. Considering that the glucocorticoids is a well-acknowledged standard treatment and that the patients might have probably received initial systemic glucocorticoids in emergency before outpatient appointment, we only excluded those who have received sufficient glucocorticoids (≥1mg/kg/d prednisone) for more than 3 days in previous 3 months;
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- Having received other systemic etiological treatments for ISSNHL (including hyperbaric oxcygen therapy (HBOT), thrombolytic drugs and antiviral drugs) which may confound the effects of study drugs. Patients who received only emergency or symptomatic treatments will not be excluded (i.e., betahistine, promethazine, diazepam, mecobalamin or ginkgo biloba leaves extracts);
- Not appropriate for receiving vestibular function tests due to combination of fracture, inflammatory or suppurative ear disease, severe cervical spondylosis or severe psychotic disorders;
- Multiple organ dysfunction or unstable vital signs;
- Pregnancy or lactation;
- Evaluated as unsuitable for the trial for any other reasons by investigators.
Trial locations and contacts
1 site in 1 country.
China1 site
Otorhinolaryngology Department, Eye and ENT Hospital of Fudan University
Shanghai, Shanghai Municipality
Huawei Li, MD, PhD, hwli@shmu.edu.cn
About this study
Official title: Vestibular Prognosis Assessment of the Idiopathic Sudden Sensorineural Hearing Loss With Vestibular Dysfunction Treated With Oral or Intratympanic Glucocorticoids
Idiopathic sudden sensorineural hearing loss (ISSNHL) is a complicated hearing impairment with unclear etiology and unsatisfying treatment effects. Vestibular dysfunction like vertigo has been considered as a risk factor of profound hearing loss and poor prognosis in ISSNHL. Glucocorticoids, administered through oral or intratympanic way, is currently a regular and standard treatment for ISSNHL based on hearing outcome. However, little investigations have been conducted on recovery process and treatment effects of glucocorticoids on vestibular dysfunctions of ISSNHL. This study aims to evaluate the recovery pattern and possible process of vestibular system in ISSNHL with vestibular dysfunction, and to compare the efficacy of oral or intratympanic glucocorticoids in these participants.
A randomized, outcome assessor- and statistical analyst-blinded, controlled, clinical trial will be carried out. 72 patients complaining of vestibular dysfunction appearing as vertigo, dizziness, imbalance or lateropulsion with ISSNHL will be recruited and randomized into two arms of oral or intratympanic glucocorticoids therapy in 1:1 allocation. The primary outcomes will be subjective feelings evaluated by duration of vestibular dysfunction symptoms, dizziness-related handicap, visual analogue scale for vertigo, and objective vestibular function tests results assessed by sensory organization test, caloric test, video head impulse test and vestibular evoked myogenic potentials. Assessment will be performed at baseline and at 1, 2, 4, and 8 weeks post-randomization.
Read the detailed description
This study is designed as an 8-week, single-center, randomized, assessor- and analyst-blinded, controlled trial with two parallel interventional groups in a 1:1 allocation.
Patients will be recruited from outpatient clinics of the Eye and ENT Hospital of Fudan University in Shanghai, qualified with well-trained doctors, staff and required facilities for this clinical trial.
- Conditions
- Vestibular Vertigo, Sudden Hearing Loss
- Being tested
- Prednisone 5Mg Tab, Methylprednisolone 40 mg
- Keywords
- idiopathic sudden sensorineural hearing loss, vestibular dysfunction, glucocorticoids
- Medical subject headings
- Vertigo, Hearing Loss, Sudden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prednisone 5Mg TabDrug
Glucocorticoids:
d1-d7: Oral Pred. 1mg/kg/d a (maximum daily dosage is no more than 60mg); d8-d9: Oral Pred. 10mg less than d7; d10-d11: Oral Pred. 10mg less than d9; d12: Oral Pred. 10mg less than d11; d13: Oral Pred. 10mg less than d12; d14: Oral Pred. 10mg less than d13;
Methylprednisolone 40 mgDrug
Glucocorticoids:
7 intratympanic injections of 40mg/ml Met. in 14 days, one injection every other day;
| Study group | Role | What they receive |
|---|---|---|
| Oral Prednisone Group | Experimental | 36 participants in Group 1 will receive oral prednisone 1mg/kg/d (maximum daily dosage is no more than 60mg) for 7 days, followed by a 7-day taper. Receives: Drug: Prednisone 5Mg Tab |
| Intratympanic Methylprednisolone Group | Experimental | 36 participants in Group 2 will receive 7 intratympanic 40mg/ml methylprednisolone injections in 14 days, one injection every other day. Receives: Drug: Methylprednisolone 40 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete recovery rates of vestibular function tests within 8 weeks
To evaluate the recovery of vestibular function and subjective vestibular dysfunction feelings, we set the recovery rates of the whole battery of vestibular function tests (SOT/caloric test/vHIT/VEMPs) as the primary outcome, which is the proportion of patients whose abnormal results of vestibular function tests at baseline recover to normal during the 8-weeks follow-up:
recovery rate (8 weeks)=(number of patients recover from abnormal result at baseline to normal during at 8-weeks follow-up)/(number of all enrolment participants patients with abnormal result at baseline)×100%;
Measured: 8 weeks from baseline
Secondary outcomes (22)
Change of SOT vestibular scores at 4-week follow-up
Change of the vestibular scores in SOT at 4-week follow-up from baseline
Measured: 4 weeks from baseline
Change of SOT vestibular scores at 8-week follow-up
Change of the vestibular scores in SOT at 8-week follow-up from baseline
Measured: 8 weeks from baseline
Change of unilateral weakness of caloric test at 4-week follow-up
Change of unilateral weakness (UW) of caloric test at 4-week follow-up
Measured: 4 weeks from baseline
Change of unilateral weakness of caloric test at 8-week follow-up
Change of UW of caloric test at 8-week follow-up
Measured: 8 weeks from baseline
Recovery rate of vHIT at 4-week follow-up
Recovery rate of vHIT at 4-week follow-up
Measured: 4 weeks from baseline
Recovery rate of vHIT at 8-week follow-up
Recovery rate of vHIT at 8-week follow-up
Measured: 8 weeks from baseline
Recovery rate of cVEMP at 4-week follow-up
Recovery rate of cVEMP at 4-week follow-up
Measured: 4 weeks from baseline
Recovery rate of cVEMP at 8-week follow-up
Recovery rate of cVEMP at 8-week follow-up
Measured: 8 weeks from baseline
Recovery rate of oVEMP at 4-week follow-up
Recovery rate of oVEMP at 4-week follow-up
Measured: 4 weeks from baseline
Recovery rate of oVEMP at 8-week follow-up
Recovery rate of oVEMP at 8-week follow-up
Measured: 8 weeks from baseline
Change of PTA at 1 week from baseline
change of average of PTA from baseline at 1-week follow-up
Measured: 1 week
Change of PTA at 2 week from baseline
change of average of PTA from baseline at 2-weeks follow-up
Measured: 2 weeks
Change of PTA at 4 week from baseline
change of average of PTA from baseline at 4-weeks follow-up
Measured: 4 weeks
Change of PTA at 8 week from baseline
change of average of PTA from baseline at 8-weeks follow-up
Measured: 8 weeks
Change of score of VAS for tinnitus (VAS-T) at 1 week from baseline
Change of scores of VAS-T from baseline at 1-week follow-up. Visual Analogue Scale for Tinnitus (VAS-T) is a universal psychometric scale evaluating subjective tinnitus. A total score is 10, from 0 to 10. The higher the score, the more severe the symptom.
Measured: 1 weeks
Change of score of VAS for vertigo (VAS-V) at 1 week from baseline
Change of scores of VAS-V from baseline at 1-week follow-up. Visual Analogue Scale for Tinnitus (VAS-T) is a universal psychometric scale evaluating subjective tinnitus. A total score is 10, from 0 to 10. The higher the score, the more severe the symptom.
Measured: 1 weeks
Change of score of VAS-T at 2 week from baseline
Change of scores of VAS-T from baseline at 2-weeks follow-up. Visual Analogue Scale for Tinnitus (VAS-T) is a universal psychometric scale evaluating subjective tinnitus. A total score is 10, from 0 to 10. The higher the score, the more severe the symptom.
Measured: 2 weeks
Change of score of VAS-V at 2 week from baseline
Change of scores of VAS-V from baseline at 2-weeks follow-up. Visual Analogue Scale for Tinnitus (VAS-T) is a universal psychometric scale evaluating subjective tinnitus. A total score is 10, from 0 to 10. The higher the score, the more severe the symptom.
Measured: 2 weeks
Change of score of VAS-T at 4 week from baseline
Change of scores of VAS-T from baseline at 4-weeks follow-up. Visual Analogue Scale for Tinnitus (VAS-T) is a universal psychometric scale evaluating subjective tinnitus. A total score is 10, from 0 to 10. The higher the score, the more severe the symptom.
Measured: 4 weeks
Change of score of VAS-V at 4 week from baseline
Change of scores of VAS-V from baseline at 4-weeks follow-up. Visual Analogue Scale for Tinnitus (VAS-T) is a universal psychometric scale evaluating subjective tinnitus. A total score is 10, from 0 to 10. The higher the score, the more severe the symptom.
Measured: 4 weeks
Change of score of VAS-T at 8 week from baseline
Change of scores of VAS-T from baseline at 8-weeks follow-up. Visual Analogue Scale for Tinntius (VAS-T) is a universal psychometric scale evaluating subjective tinnitus. A total score is 10, from 0 to 10. The higher the score, the more severe the symptom.
Measured: 8 weeks
Change of score of VAS-V at 8 week from baseline
Change of scores of VAS-V from baseline at 8-weeks follow-up. Visual Analogue Scale for Tinntius (VAS-T) is a universal psychometric scale evaluating subjective tinnitus. A total score is 10, from 0 to 10. The higher the score, the more severe the symptom.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2019
- Study startJul 2019 (estimated)
- Primary completionJul 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Vestibular VertigoStudies of the same condition, open and under way.
- More trials run by Eye & ENT Hospital of Fudan UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eye & ENT Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huawei Li, MD, PhD, Study chair, Eye & ENT Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03974867
- Sponsor's protocol ID
- ISSNHL RCT
- Status last verified
- Jun 2019
- First submitted
- 3 Jun 2019
- Last updated
- 24 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stachler RJ, Chandrasekhar SS, Archer SM, Rosenfeld RM, Schwartz SR, Barrs DM, Brown SR, Fife TD, Ford P, Ganiats TG, Hollingsworth DB, Lewandowski CA, Montano JJ, Saunders JE, Tucci DL, Valente M, Warren BE, Yaremchuk KL, Robertson PJ; American Academy of Otolaryngology-Head and Neck Surgery. Clinical practice guideline: sudden hearing loss. Otolaryngol Head Neck Surg. 2012 Mar;146(3 Suppl):S1-35. doi: 10.1177/0194599812436449.
PubMed 22383545Rauch SD, Halpin CF, Antonelli PJ, Babu S, Carey JP, Gantz BJ, Goebel JA, Hammerschlag PE, Harris JP, Isaacson B, Lee D, Linstrom CJ, Parnes LS, Shi H, Slattery WH, Telian SA, Vrabec JT, Reda DJ. Oral vs intratympanic corticosteroid therapy for idiopathic sudden sensorineural hearing loss: a randomized trial. JAMA. 2011 May 25;305(20):2071-9. doi: 10.1001/jama.2011.679.
PubMed 21610239Yu H, Li H. Association of Vertigo With Hearing Outcomes in Patients With Sudden Sensorineural Hearing Loss: A Systematic Review and Meta-analysis. JAMA Otolaryngol Head Neck Surg. 2018 Aug 1;144(8):677-683. doi: 10.1001/jamaoto.2018.0648.
PubMed 29931169Yu H, Li H. Vestibular Dysfunctions in Sudden Sensorineural Hearing Loss: A Systematic Review and Meta-analysis. Front Neurol. 2018 Feb 5;9:45. doi: 10.3389/fneur.2018.00045. eCollection 2018.
PubMed 29459846Hao W, Zhao L, Yu H, Li H. Vestibular prognosis in idiopathic sudden sensorineural hearing loss with vestibular dysfunction treated with oral or intratympanic glucocorticoids: a protocol for randomized controlled trial. Trials. 2020 Jul 22;21(1):669. doi: 10.1186/s13063-020-04579-6.
PubMed 32698830
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vestibular Prognosis Assessment of the Idiopathic Sudden Sensorineural Hearing Loss With Vestibular Dysfunction Treated With Oral or Intratympanic Glucocorticoids
- ClinicalTrials.gov ID
- NCT03974867
- Acronym / sponsor ID
- ISSNHL RCT
- Conditions
- Vestibular Vertigo, Sudden Hearing Loss
- Keywords
- idiopathic sudden sensorineural hearing loss, vestibular dysfunction, glucocorticoids
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- Jul 2019 (estimated)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 5 Jun 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.
Idiopathic sudden sensorineural hearing loss (ISSNHL) is a complicated hearing impairment with unclear etiology and unsatisfying treatment effects. Vestibular dysfunction like vertigo has been considered as a risk factor of profound hearing loss and poor prognosis in ISSNHL. Glucocorticoids, administered through oral or intratympanic way, is currently a regular and standard treatment for ISSNHL based on hearing outcome. However, little investigations have been conducted on recovery process and treatment effects of glucocorticoids on vestibular dysfunctions of ISSNHL. This study aims to evaluate the recovery pattern and possible process of vestibular system in ISSNHL with vestibular dysfunction, and to compare the efficacy of oral or intratympanic glucocorticoids in these participants.
A randomized, outcome assessor- and statistical analyst-blinded, controlled, clinical trial will be carried out. 72 patients complaining of vestibular dysfunction appearing as vertigo, dizziness, imbalance or lateropulsion with ISSNHL will be recruited and randomized into two arms of oral or intratympanic glucocorticoids therapy in 1:1 allocation. The primary outcomes will be subjective feelings evaluated by duration of vestibular dysfunction symptoms, dizziness-related handicap, visual analogue scale for vertigo, and objective vestibular function tests results assessed by sensory organization test, caloric test, video head impulse test and vestibular evoked myogenic potentials. Assessment will be performed at baseline and at 1, 2, 4, and 8 weeks post-randomization.
Detailed description
This study is designed as an 8-week, single-center, randomized, assessor- and analyst-blinded, controlled trial with two parallel interventional groups in a 1:1 allocation.
Patients will be recruited from outpatient clinics of the Eye and ENT Hospital of Fudan University in Shanghai, qualified with well-trained doctors, staff and required facilities for this clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Prednisone Group | Experimental | Drug: Prednisone 5Mg Tab36 participants in Group 1 will receive oral prednisone 1mg/kg/d (maximum daily dosage is no more than 60mg) for 7 days, followed by a 7-day taper. |
| Intratympanic Methylprednisolone Group | Experimental | Drug: Methylprednisolone 40 mg36 participants in Group 2 will receive 7 intratympanic 40mg/ml methylprednisolone injections in 14 days, one injection every other day. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged between 18 to 70 years old;
- Diagnosed with unilateral ISSNHL according to the National Institute for Deafness and Communication Disorders (NICDC) criteria30: a decrease in hearing of ≥30 decibels (dB), affecting at least 3 consecutive frequencies occurring within a 72-hour period. Since premorbid audiometry is generally unavailable, premorbid hearing level will be defined as the opposite ear's thresholds in this condition;
- Reported vertigo/dizziness/imbalance/lateropulsion and abnormal results in at least one of the vestibular function tests (including SOT, caloric test, vHIT, cVEMP, and oVEMP);
- Onset of audio-vestibular symptoms occurred within 7 days;
- Be willing to sign the informed consent of the study.
Key exclusion criteria (11 listed)
- Definite etiologies are found or highly suspected after clinical evaluations, such as vestibular schwannoma, stroke, trauma or demyelinating disease;
- Diagnosed with a present or previous hearing or balance disorders which might be confused with ISSNHL (history of Meniere's disease, benign paroxysmal positional vertigo, vestibular neuronitis or vestibular migraine; history of otosclerosis; history of luetic, congenital or genetic hearing loss, etc.);
- Hearing level (evaluated with PTA) in the unaffected ear is abnormal, so that a premorbid hearing level of the affected ear may not be estimated;
- Suspected as central vestibular dysfunction, evaluated by present and previous medical history, physical examination and VNG;
- Present with conditions contraindicated systemic glucocorticoids use, such as tuberculosis, hepatitis C or B infection, active herpes zoster infection or other known human immunodeficiency virus, pancreatitis, insulin-dependent diabetes mellitus, severe osteoporosis, chronic renal insufficiency or gastrointestinal ulcer;
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 |
|---|---|---|
| Prednisone 5Mg TabGlucocorticoids: d1-d7: Oral Pred. 1mg/kg/d a (maximum daily dosage is no more than 60mg); d8-d9: Oral Pred. 10mg less than d7; d10-d11: Oral Pred. 10mg less than d9; d12: Oral Pred. 10mg less than d11; d13: Oral Pred. 10mg less than d12; d14: Oral Pred. 10mg less than d13; | Drug | Oral Prednisone Group |
| Methylprednisolone 40 mgGlucocorticoids: 7 intratympanic injections of 40mg/ml Met. in 14 days, one injection every other day; | Drug | Intratympanic Methylprednisolone Group |
Primary outcome
Complete recovery rates of vestibular function tests within 8 weeks
Time frame: 8 weeks from baseline
To evaluate the recovery of vestibular function and subjective vestibular dysfunction feelings, we set the recovery rates of the whole battery of vestibular function tests (SOT/caloric test/vHIT/VEMPs) as the primary outcome, which is the proportion of patients whose abnormal results of vestibular function tests at baseline recover to normal during the 8-weeks follow-up: recovery rate (8 weeks)=(number of patients recover from abnormal result at baseline to normal during at 8-weeks follow-up)/(number of all enrolment participants patients with abnormal result at baseline)×100%;
22 secondary outcomes
Change of SOT vestibular scores at 4-week follow-up
Time frame: 4 weeks from baseline
Change of SOT vestibular scores at 8-week follow-up
Time frame: 8 weeks from baseline
Change of unilateral weakness of caloric test at 4-week follow-up
Time frame: 4 weeks from baseline
Change of unilateral weakness of caloric test at 8-week follow-up
Time frame: 8 weeks from baseline
Recovery rate of vHIT at 4-week follow-up
Time frame: 4 weeks from baseline
Recovery rate of vHIT at 8-week follow-up
Time frame: 8 weeks from baseline
Recovery rate of cVEMP at 4-week follow-up
Time frame: 4 weeks from baseline
Recovery rate of cVEMP at 8-week follow-up
Time frame: 8 weeks from baseline
Recovery rate of oVEMP at 4-week follow-up
Time frame: 4 weeks from baseline
Recovery rate of oVEMP at 8-week follow-up
Time frame: 8 weeks from baseline
Change of PTA at 1 week from baseline
Time frame: 1 week
Change of PTA at 2 week from baseline
Time frame: 2 weeks
Change of PTA at 4 week from baseline
Time frame: 4 weeks
Change of PTA at 8 week from baseline
Time frame: 8 weeks
Change of score of VAS for tinnitus (VAS-T) at 1 week from baseline
Time frame: 1 weeks
Change of score of VAS for vertigo (VAS-V) at 1 week from baseline
Time frame: 1 weeks
Change of score of VAS-T at 2 week from baseline
Time frame: 2 weeks
Change of score of VAS-V at 2 week from baseline
Time frame: 2 weeks
Change of score of VAS-T at 4 week from baseline
Time frame: 4 weeks
Change of score of VAS-V at 4 week from baseline
Time frame: 4 weeks
Change of score of VAS-T at 8 week from baseline
Time frame: 8 weeks
Change of score of VAS-V at 8 week from baseline
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2019.
- Background: PubMed 22383545Stachler RJ, Chandrasekhar SS, Archer SM, Rosenfeld RM, Schwartz SR, Barrs DM, Brown SR, Fife TD, Ford P, Ganiats TG, Hollingsworth DB, Lewandowski CA, Montano JJ, Saunders JE, Tucci DL, Valente M, Warren BE, Yaremchuk KL, Robertson PJ; American Academy of Otolaryngology-Head and Neck Surgery. Clinical practice guideline: sudden hearing loss. Otolaryngol Head Neck Surg. 2012 Mar;146(3 Suppl):S1-35. doi: 10.1177/0194599812436449.
- Background: PubMed 21610239Rauch SD, Halpin CF, Antonelli PJ, Babu S, Carey JP, Gantz BJ, Goebel JA, Hammerschlag PE, Harris JP, Isaacson B, Lee D, Linstrom CJ, Parnes LS, Shi H, Slattery WH, Telian SA, Vrabec JT, Reda DJ. Oral vs intratympanic corticosteroid therapy for idiopathic sudden sensorineural hearing loss: a randomized trial. JAMA. 2011 May 25;305(20):2071-9. doi: 10.1001/jama.2011.679.
- Background: PubMed 29931169Yu H, Li H. Association of Vertigo With Hearing Outcomes in Patients With Sudden Sensorineural Hearing Loss: A Systematic Review and Meta-analysis. JAMA Otolaryngol Head Neck Surg. 2018 Aug 1;144(8):677-683. doi: 10.1001/jamaoto.2018.0648.
- Background: PubMed 29459846Yu H, Li H. Vestibular Dysfunctions in Sudden Sensorineural Hearing Loss: A Systematic Review and Meta-analysis. Front Neurol. 2018 Feb 5;9:45. doi: 10.3389/fneur.2018.00045. eCollection 2018.
- Derived from this study: PubMed 32698830Hao W, Zhao L, Yu H, Li H. Vestibular prognosis in idiopathic sudden sensorineural hearing loss with vestibular dysfunction treated with oral or intratympanic glucocorticoids: a protocol for randomized controlled trial. Trials. 2020 Jul 22;21(1):669. doi: 10.1186/s13063-020-04579-6.
- Individual participant dataSharing planned: No
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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.
Huawei Li, MD, PhD study chair
Eye & ENT Hospital of Fudan 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 Prednisone 5Mg Tab and Methylprednisolone 40 mg in people with Vestibular Vertigo and Sudden Hearing Loss, run by Eye & ENT Hospital of Fudan University 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 5 inclusion and 11 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 24 Jul 2019. 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 Weiming Hao, MD (+86-13761816819, wmhao12@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete recovery rates of vestibular function tests within 8 weeks (time frame: 8 weeks from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03974867, which also lists 5 linked publications.
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 24 Jul 2019.