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Vestibular Prognosis Assessment of ISSNHL With Vestibular Dysfunction Treated With Oral or Intratympanic Glucocorticoids

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ClinicalTrials.gov Identifier: NCT03974867
Recruitment Status : Not yet recruiting
First Posted : June 5, 2019
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
Eye & ENT Hospital of Fudan University

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Vestibular Vertigo Sudden Hearing Loss Drug: Prednisone 5Mg Tab Drug: Methylprednisolone 40 mg Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vestibular Prognosis Assessment of the Idiopathic Sudden Sensorineural Hearing Loss With Vestibular Dysfunction Treated With Oral or Intratympanic Glucocorticoids
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : December 2020


Arm Intervention/treatment
Experimental: Oral Prednisone Group
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.
Drug: Prednisone 5Mg Tab

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;


Experimental: Intratympanic Methylprednisolone Group
36 participants in Group 2 will receive 7 intratympanic 40mg/ml methylprednisolone injections in 14 days, one injection every other day.
Drug: Methylprednisolone 40 mg

Glucocorticoids:

7 intratympanic injections of 40mg/ml Met. in 14 days, one injection every other day;





Primary Outcome Measures :
  1. 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%;



Secondary Outcome Measures :
  1. Change of SOT vestibular scores at 4-week follow-up [ Time Frame: 4 weeks from baseline ]
    Change of the vestibular scores in SOT at 4-week follow-up from baseline

  2. Change of SOT vestibular scores at 8-week follow-up [ Time Frame: 8 weeks from baseline ]
    Change of the vestibular scores in SOT at 8-week follow-up from baseline

  3. Change of unilateral weakness of caloric test at 4-week follow-up [ Time Frame: 4 weeks from baseline ]
    Change of unilateral weakness (UW) of caloric test at 4-week follow-up

  4. Change of unilateral weakness of caloric test at 8-week follow-up [ Time Frame: 8 weeks from baseline ]
    Change of UW of caloric test at 8-week follow-up

  5. Recovery rate of vHIT at 4-week follow-up [ Time Frame: 4 weeks from baseline ]
    Recovery rate of vHIT at 4-week follow-up

  6. Recovery rate of vHIT at 8-week follow-up [ Time Frame: 8 weeks from baseline ]
    Recovery rate of vHIT at 8-week follow-up

  7. Recovery rate of cVEMP at 4-week follow-up [ Time Frame: 4 weeks from baseline ]
    Recovery rate of cVEMP at 4-week follow-up

  8. Recovery rate of cVEMP at 8-week follow-up [ Time Frame: 8 weeks from baseline ]
    Recovery rate of cVEMP at 8-week follow-up

  9. Recovery rate of oVEMP at 4-week follow-up [ Time Frame: 4 weeks from baseline ]
    Recovery rate of oVEMP at 4-week follow-up

  10. Recovery rate of oVEMP at 8-week follow-up [ Time Frame: 8 weeks from baseline ]
    Recovery rate of oVEMP at 8-week follow-up

  11. Change of PTA at 1 week from baseline [ Time Frame: 1 week ]
    change of average of PTA from baseline at 1-week follow-up

  12. Change of PTA at 2 week from baseline [ Time Frame: 2 weeks ]
    change of average of PTA from baseline at 2-weeks follow-up

  13. Change of PTA at 4 week from baseline [ Time Frame: 4 weeks ]
    change of average of PTA from baseline at 4-weeks follow-up

  14. Change of PTA at 8 week from baseline [ Time Frame: 8 weeks ]
    change of average of PTA from baseline at 8-weeks follow-up

  15. Change of score of VAS for tinnitus (VAS-T) at 1 week from baseline [ Time Frame: 1 weeks ]
    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.

  16. Change of score of VAS for vertigo (VAS-V) at 1 week from baseline [ Time Frame: 1 weeks ]
    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.

  17. Change of score of VAS-T at 2 week from baseline [ Time Frame: 2 weeks ]
    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.

  18. Change of score of VAS-V at 2 week from baseline [ Time Frame: 2 weeks ]
    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.

  19. Change of score of VAS-T at 4 week from baseline [ Time Frame: 4 weeks ]
    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.

  20. Change of score of VAS-V at 4 week from baseline [ Time Frame: 4 weeks ]
    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.

  21. Change of score of VAS-T at 8 week from baseline [ Time Frame: 8 weeks ]
    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.

  22. Change of score of VAS-V at 8 week from baseline [ Time Frame: 8 weeks ]
    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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adults aged between 18 to 70 years old;
  2. 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;
  3. 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);
  4. Onset of audio-vestibular symptoms occurred within 7 days;
  5. Be willing to sign the informed consent of the study.

Exclusion Criteria:

  1. Definite etiologies are found or highly suspected after clinical evaluations, such as vestibular schwannoma, stroke, trauma or demyelinating disease;
  2. 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.);
  3. 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;
  4. Suspected as central vestibular dysfunction, evaluated by present and previous medical history, physical examination and VNG;
  5. 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;
  6. 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;
  7. 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);
  8. Not appropriate for receiving vestibular function tests due to combination of fracture, inflammatory or suppurative ear disease, severe cervical spondylosis or severe psychotic disorders;
  9. Multiple organ dysfunction or unstable vital signs;
  10. Pregnancy or lactation;
  11. Evaluated as unsuitable for the trial for any other reasons by investigators.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03974867


Contacts
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Contact: Weiming Hao, MD +86-13761816819 wmhao12@fudan.edu.cn
Contact: Huiqian Yu, MD, PhD +86-13636423139 yhq925@163.com

Locations
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China, Shanghai
Otorhinolaryngology Department, Eye and ENT Hospital of Fudan University Not yet recruiting
Shanghai, Shanghai, China
Contact: Huawei Li, MD, PhD       hwli@shmu.edu.cn   
Sponsors and Collaborators
Eye & ENT Hospital of Fudan University
Investigators
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Study Chair: Huawei Li, MD, PhD Eye and ENT Hospital of Fudan University

Publications:
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Responsible Party: Eye & ENT Hospital of Fudan University
ClinicalTrials.gov Identifier: NCT03974867     History of Changes
Other Study ID Numbers: ISSNHL RCT
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Eye & ENT Hospital of Fudan University:
idiopathic sudden sensorineural hearing loss
vestibular dysfunction
glucocorticoids

Additional relevant MeSH terms:
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Hearing Loss
Deafness
Vertigo
Hearing Loss, Sensorineural
Hearing Loss, Sudden
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Vestibular Diseases
Labyrinth Diseases
Prednisone
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Glucocorticoids
Anti-Inflammatory Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics