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

Sudden Hearing Loss Clinical Trial

Official title:

Vestibular Prognosis Assessment of the Idiopathic Sudden Sensorineural Hearing Loss With Vestibular Dysfunction Treated With Oral or Intratympanic Glucocorticoids

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03974867
• Other study ID #: ISSNHL RCT
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2019
• Est. completion date: December 2020

Study information

• Verified date: June 2019
• Source: Eye & ENT Hospital of Fudan University
• Contact: Weiming Hao, MD
• Phone: +86-13761816819
• Email: wmhao12[@]fudan.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 72
• Est. completion date: December 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Hearing Loss, Sensorineural
• Hearing Loss, Sudden
• Sudden Hearing Loss
• Vertigo
• Vestibular Vertigo

Intervention

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

Locations

Country	Name	City	State
China	Otorhinolaryngology Department, Eye and ENT Hospital of Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Eye & ENT Hospital of Fudan University

Country where clinical trial is conducted

China, 

References & Publications (4)

Rauch 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. — View Citation

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. — View Citation

Yu 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. — View Citation

Yu 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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%;	8 weeks from baseline
Secondary	Change of SOT vestibular scores at 4-week follow-up	Change of the vestibular scores in SOT at 4-week follow-up from baseline	4 weeks from baseline
Secondary	Change of SOT vestibular scores at 8-week follow-up	Change of the vestibular scores in SOT at 8-week follow-up from baseline	8 weeks from baseline
Secondary	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	4 weeks from baseline
Secondary	Change of unilateral weakness of caloric test at 8-week follow-up	Change of UW of caloric test at 8-week follow-up	8 weeks from baseline
Secondary	Recovery rate of vHIT at 4-week follow-up	Recovery rate of vHIT at 4-week follow-up	4 weeks from baseline
Secondary	Recovery rate of vHIT at 8-week follow-up	Recovery rate of vHIT at 8-week follow-up	8 weeks from baseline
Secondary	Recovery rate of cVEMP at 4-week follow-up	Recovery rate of cVEMP at 4-week follow-up	4 weeks from baseline
Secondary	Recovery rate of cVEMP at 8-week follow-up	Recovery rate of cVEMP at 8-week follow-up	8 weeks from baseline
Secondary	Recovery rate of oVEMP at 4-week follow-up	Recovery rate of oVEMP at 4-week follow-up	4 weeks from baseline
Secondary	Recovery rate of oVEMP at 8-week follow-up	Recovery rate of oVEMP at 8-week follow-up	8 weeks from baseline
Secondary	Change of PTA at 1 week from baseline	change of average of PTA from baseline at 1-week follow-up	1 week
Secondary	Change of PTA at 2 week from baseline	change of average of PTA from baseline at 2-weeks follow-up	2 weeks
Secondary	Change of PTA at 4 week from baseline	change of average of PTA from baseline at 4-weeks follow-up	4 weeks
Secondary	Change of PTA at 8 week from baseline	change of average of PTA from baseline at 8-weeks follow-up	8 weeks
Secondary	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.	1 weeks
Secondary	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.	1 weeks
Secondary	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.	2 weeks
Secondary	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.	2 weeks
Secondary	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.	4 weeks
Secondary	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.	4 weeks
Secondary	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.	8 weeks
Secondary	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.	8 weeks