- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03951584
Prognosis of Vestibular Dysfunction in Patients With Idiopathic Sudden Sensorineural Hearing Loss
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Shanghai
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Shanghai, Shanghai, China, 200031
- Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University, Shanghai, China
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 16 to 70 years old.
- Diagnosed as ISSNHL.
- Present with vertigo.
- At least 1 abnormal result in vestibular function tests(SOT, vHIT, caloric reflex test, and VEMP).
- The onset of the disease was within 30 days.
Exclusion Criteria:
- Unwilling to sign informed consent.
- The cause of sudden hearing loss has been identified, such as trauma, vasogenic disease, et al.
- Bilateral hearing loss.
- Patients with coexisting vestibular disorders, including Meniere disease, vestibular neuritis, labyrinthitis, and peripheral vestibular loss et al.
- Patients not suitable to receiving vestibular function tests, such as those with severe cervical spine disease, cardiovascular disease, or pregnancy et al.
- Cognitive impairment;
- Other conditions that the investigator evaluated the patients as not appropriate for this study.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
ISSNHL with vertigo
Participants who suffered from ISSNHL with vertigo will be included in this study cohort.
Participants will undergo vestibular function tests including caloric test, sensory organization test, video head impulse test and vestibular evoked myogenic potentials at baseline and 2 months after onset, to evaluate the damage and prognosis of vestibular function.
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Participants who suffered from ISSNHL with vertigo will be included in this study.
Participants will undergo vestibular function tests including caloric test, sensory organization test, video head impulse test and vestibular evoked myogenic potentials at baseline and 2 months after onset as primary outcome, to evaluate the damage and prognosis of vestibular function.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Abnormal rate of vestibular function in the Sensory Organization Test(SOT) at baseline.
Time Frame: Baseline
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abnormal rate=(number of participants who have abnormal results in vestibular function in SOT at the baseline)/(number of participants in total)
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Baseline
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Recovery rate of vestibular input in the Sensory Organization Test(SOT) at 2-months follow-up after onset.
Time Frame: 2 months after onset
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recovery rate=(number of participants who had abnormal results in vestibular function in SOT at the baseline and get normal vestibular function results in SOT at 2-months follow-up after onset)/(number of participants who had abnormal vestibular function results in SOT at the baseline)
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2 months after onset
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Abnormal rate of the caloric test at baseline.
Time Frame: Baseline
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Abnormal rate=(number of participants who have abnormal results in the caloric test at the baseline)/(number of participants in total). An abnormal result is considered if unilateral reaction weakening is greater than 22%, and/or directional preponderance is greater than 27%. |
Baseline
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Recovery rate of the caloric test at 2-months follow-up after onset.
Time Frame: 2 months after onset
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recovery rate=(number of participants who had abnormal results in the caloric test at the baseline and get normal results in the caloric test at 2-months follow-up after onset)/(number of participants who get abnormal results in the caloric test at the baseline). An abnormal result is considered if unilateral reaction weakening is greater than 22%, and/or directional preponderance is greater than 27%. |
2 months after onset
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Abnormal rate of the vHIT at baseline.
Time Frame: Baseline
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Abnormal rate=(number of participants who have abnormal results in vHIT at the baseline)/(number of participants in total). An abnormal result is considered if there are pathological saccades and the gain of each semicircular canal is out of normal range. |
Baseline
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Recovery rate of the vHIT at 2-months follow-up after onset.
Time Frame: 2 months after onset
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recovery rate=(number of the participants who had abnormal results in vHIT at the baseline and get normal results in vHIT at 2-months follow-up after onset)/(number of the participants who get abnormal results in vHIT at the baseline). An abnormal result is considered if there are pathological saccades and the gain of each semicircular canal is out of normal range. |
2 months after onset
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Abnormal rate of Cervical Vestibular Evoked Myogenic Potentials (cVEMP) at baseline.
Time Frame: Baseline
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Abnormal rate=(number of participants who have abnormal results in cVEMP at the baseline)/(number of participants in total) The abnormal result is considered if potentials were not elicited or out of normal range, or the asymmetrical ratio is larger than normal.
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Baseline
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Recovery rate of Cervical Vestibular Evoked Myogenic Potentials (cVEMP) at 2-months follow-up after onset.
Time Frame: 2 months after onset
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recovery rate=(number of the participants who had abnormal results in cVEMP at the baseline and get normal results in cVEMP at 2-months follow-up after onset)/(number of the participants who had abnormal results in cVEMP at the baseline) The abnormal result is considered if potentials were not elicited or out of normal range, or the asymmetrical ratio is larger than normal.
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2 months after onset
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Abnormal rate of Ocular Vestibular Evoked Myogenic Potentials (oVEMP) at baseline.
Time Frame: Baseline
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Abnormal rate=(number of participants who had abnormal results in oVEMP at the baseline)/(number of participants in total) The abnormal result is considered if potentials were not elicited or out of normal range, or the asymmetrical ratio is larger than normal.
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Baseline
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Recovery rate of Ocular Vestibular Evoked Myogenic Potentials (oVEMP) at 2-months follow-up after onset.
Time Frame: 2 months after onset
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recovery rate=(number of the participants who had abnormal results in oVEMP at the baseline and get normal results in oVEMP at 2-months follow-up after onset)/(number of the participants who had abnormal results in oVEMP at the baseline) The abnormal result is considered if potentials were not elicited or out of normal range, or the asymmetrical ratio is larger than normal.
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2 months after onset
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of Dizziness Handicap Inventory at 2 months after onset
Time Frame: 2 months after onset
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Mean value of change of DHI from baseline at 2 months after onset in each participant. Subjective evaluation of vertigo by participants. Score range from 0 to 100 (0 refers to no influence on daily life, while 100 refers to the most severe influence on patient's daily life.) |
2 months after onset
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Change of Visual Analogue Scale in Vertigo at 2 month after onset
Time Frame: 2 months after onset
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Mean value of change of VAS-V from baseline at 2 months after onset in each participant. Subjective evaluation of vertigo by participants. Score from 0 to 10. The larger the score, the more severe the vertigo is. |
2 months after onset
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Change of Pure Tone Audiometry(PTA) at 2 months after onset
Time Frame: 2 months after onset
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mean value of change of PTA in each participant at 2 months after onset from baseline (if the participants can provide with an earlier PTA result before enrollment and after onset, which we believe is of high possibility, this PTA result will be considered as baseline parameters).
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2 months after onset
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Collaborators and Investigators
Investigators
- Study Chair: Huawei Li, Phd & MD, Eye and ENT Hospital of Fudan University
Publications and helpful links
General 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.
- Wen YH, Chen PR, Wu HP. Prognostic factors of profound idiopathic sudden sensorineural hearing loss. Eur Arch Otorhinolaryngol. 2014 Jun;271(6):1423-9. doi: 10.1007/s00405-013-2593-y. Epub 2013 Jun 15.
- 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.
- Rauch SD. Clinical practice. Idiopathic sudden sensorineural hearing loss. N Engl J Med. 2008 Aug 21;359(8):833-40. doi: 10.1056/NEJMcp0802129. No abstract available.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Cohort ISSNHL with vertigo
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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