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出境医 / 临床实验 / Prognosis of Vestibular Dysfunction in Patients With Idiopathic Sudden Sensorineural Hearing Loss

Prognosis of Vestibular Dysfunction in Patients With Idiopathic Sudden Sensorineural Hearing Loss

Study Description
Brief Summary:
Idiopathic sudden sensorineural hearing loss (ISSNHL) refers to idiopathic sensorineural hearing loss of at least 30 dB over at least three test frequencies occurring over a 72-hour period. Vertigo has been considered a risk factor of poor prognosis in patients with ISSNHL. However, the clinical outcome and development of vestibular function in these patients have not been reported yet. We'd like to conduct a study on the problem whether these patients resulted in a complete recovery of the peripheral vestibular functions or compensation of the central vestibular system. If the answer is the former one, these cases might be supportive evidence of regeneration of hair cells in vestibular disorders.

Condition or disease Intervention/treatment
Vestibular Disorder Sudden Hearing Loss Other: ISSNHL with vertigo

Detailed Description:
This study is designed as a prospective cohort study with only one cohort. Enrolment and data collection are performed by trained research staff who are not involved in the care of the patients. The primary measurement is the vestibular function tests including SOT, the caloric reflex test, vHIT, VEMP (cVEMP and oVEMP). The secondary measurements included PTA, DHI, and VAS. The sample size was set at 60 patients. The continuous variables were expressed as means ± standard deviation (SD) whereas categorical variables were expressed as frequency and percentage for data description. P <0.05 was considered statistically significant.
Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prognosis of Vestibular Dysfunction in Patients With Idiopathic Sudden Sensorineural Hearing Loss
Actual Study Start Date : May 15, 2019
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : June 2021
Arms 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.
 Other: ISSNHL with vertigo
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.
Outcome Measures
Primary Outcome Measures :
  1. Abnormal rate of vestibular function in the Sensory Organization Test(SOT) at baseline. [ Time Frame: Baseline ]
    abnormal rate=(number of participants who have abnormal results in vestibular function in SOT at the baseline)/(number of participants in total)

  2. Recovery rate of vestibular input in the Sensory Organization Test(SOT) at 2-months follow-up after onset. [ Time Frame: 2 months after onset ]
    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)

  3. Abnormal rate of the caloric test at baseline. [ Time Frame: Baseline ]

    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%.


  4. Recovery rate of the caloric test at 2-months follow-up after onset. [ Time Frame: 2 months after onset ]

    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%.


  5. Abnormal rate of the vHIT at baseline. [ Time Frame: Baseline ]

    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.


  6. Recovery rate of the vHIT at 2-months follow-up after onset. [ Time Frame: 2 months after onset ]

    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.


  7. Abnormal rate of Cervical Vestibular Evoked Myogenic Potentials (cVEMP) at baseline. [ Time Frame: Baseline ]
    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.

  8. Recovery rate of Cervical Vestibular Evoked Myogenic Potentials (cVEMP) at 2-months follow-up after onset. [ Time Frame: 2 months after onset ]
    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.

  9. Abnormal rate of Ocular Vestibular Evoked Myogenic Potentials (oVEMP) at baseline. [ Time Frame: Baseline ]
    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.

  10. Recovery rate of Ocular Vestibular Evoked Myogenic Potentials (oVEMP) at 2-months follow-up after onset. [ Time Frame: 2 months after onset ]
    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.

  11. Change of subjective complaint of vertigo/dizziness from baseline at 2-months follow-up after onset. [ Time Frame: 2 months after onset ]
    The number of participants who complain of vertigo/dizziness disappeared, still exist but improved, no change/worsening compared with baseline at 2-months follow-up after onset.


Secondary Outcome Measures :
  1. Change of Dizziness Handicap Inventory at 1 month after onset [ Time Frame: 1 month after onset ]

    Mean value of change of DHI from baseline at 1 month 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 the patient's daily life.


  2. Change of Dizziness Handicap Inventory at 2 months after onset [ Time Frame: 2 months after onset ]

    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.)


  3. Change of Visual Analogue Scale in Vertigo(VAS-V) at 1 month after onset [ Time Frame: 1 month after onset ]

    Mean value of change of VAS-V from baseline at 1 month 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.


  4. Change of Visual Analogue Scale in Vertigo at 2 month after onset [ Time Frame: 2 months after onset ]

    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.


  5. Change of Visual Analogue Scale in Tinnitus (VAS-T) at 2 month after onset [ Time Frame: 2 months after onset ]

    Mean value of change of VAS-T 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.


  6. Change of Pure Tone Audiometry(PTA) at 1 month after onset [ Time Frame: 1 month after onset ]
    mean value of change of PTA in each participant at 1 month 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).

  7. Change of Pure Tone Audiometry(PTA) at 2 months after onset [ Time Frame: 2 months after onset ]
    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).

  8. Change of subjective complaint of vertigo/dizziness from baseline at 1-month follow-up after onset. [ Time Frame: 1 month after onset ]
    The number of participants who complain of vertigo/dizziness disappeared, still exist but improved, no change/worsening compared with baseline at 1-month follow-up after onset.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   up to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients who suffered from ISSNHL with vertigo and the onset of this disease was within 30 days, will be included in this study cohort. The enrollment of the participants will be held in the clinic of Eye and ENT Hospital of Fudan University.
Criteria

Inclusion Criteria:

  • Younger than 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.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Huiqian Yu, Phd & MD 8613636423139 yhq925@163.com
Contact: Weiming Hao, MD 8613761816819 wmhao12@fudan.edu.cn

Locations
Layout table for location information
China, Shanghai
Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University, Shanghai, China Recruiting
Shanghai, Shanghai, China, 200031
Contact: Huawei Li, Phd &MD       hwli@shmu.edu.cn   
Contact: Weiming Hao, MD       wmhao12@fudan.edu.cn   
Principal Investigator: Huawei Li, Phd & MD         
Principal Investigator: Huiqian Yu, Phd & MD         
Principal Investigator: Weiming Hao, MD         
Sponsors and Collaborators
Eye & ENT Hospital of Fudan University
Investigators
Layout table for investigator information
Study Chair: Huawei Li, Phd & MD Eye and ENT Hospital of Fudan University
Tracking Information
First Submitted Date May 6, 2019
First Posted Date May 15, 2019
Last Update Posted Date February 9, 2021
Actual Study Start Date May 15, 2019
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 14, 2019)
  • Abnormal rate of vestibular function in the Sensory Organization Test(SOT) at baseline. [ Time Frame: Baseline ]
    abnormal rate=(number of participants who have abnormal results in vestibular function in SOT at the baseline)/(number of participants in total)
  • Recovery rate of vestibular input in the Sensory Organization Test(SOT) at 2-months follow-up after onset. [ Time Frame: 2 months after onset ]
    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)
  • Abnormal rate of the caloric test at baseline. [ Time Frame: Baseline ]
    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%.
  • Recovery rate of the caloric test at 2-months follow-up after onset. [ Time Frame: 2 months after onset ]
    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%.
  • Abnormal rate of the vHIT at baseline. [ Time Frame: Baseline ]
    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.
  • Recovery rate of the vHIT at 2-months follow-up after onset. [ Time Frame: 2 months after onset ]
    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.
  • Abnormal rate of Cervical Vestibular Evoked Myogenic Potentials (cVEMP) at baseline. [ Time Frame: Baseline ]
    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.
  • Recovery rate of Cervical Vestibular Evoked Myogenic Potentials (cVEMP) at 2-months follow-up after onset. [ Time Frame: 2 months after onset ]
    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.
  • Abnormal rate of Ocular Vestibular Evoked Myogenic Potentials (oVEMP) at baseline. [ Time Frame: Baseline ]
    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.
  • Recovery rate of Ocular Vestibular Evoked Myogenic Potentials (oVEMP) at 2-months follow-up after onset. [ Time Frame: 2 months after onset ]
    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.
  • Change of subjective complaint of vertigo/dizziness from baseline at 2-months follow-up after onset. [ Time Frame: 2 months after onset ]
    The number of participants who complain of vertigo/dizziness disappeared, still exist but improved, no change/worsening compared with baseline at 2-months follow-up after onset.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 14, 2019)
  • Change of Dizziness Handicap Inventory at 1 month after onset [ Time Frame: 1 month after onset ]
    Mean value of change of DHI from baseline at 1 month 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 the patient's daily life.
  • Change of Dizziness Handicap Inventory at 2 months after onset [ Time Frame: 2 months after onset ]
    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.)
  • Change of Visual Analogue Scale in Vertigo(VAS-V) at 1 month after onset [ Time Frame: 1 month after onset ]
    Mean value of change of VAS-V from baseline at 1 month 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.
  • Change of Visual Analogue Scale in Vertigo at 2 month after onset [ Time Frame: 2 months after onset ]
    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.
  • Change of Visual Analogue Scale in Tinnitus (VAS-T) at 2 month after onset [ Time Frame: 2 months after onset ]
    Mean value of change of VAS-T 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.
  • Change of Pure Tone Audiometry(PTA) at 1 month after onset [ Time Frame: 1 month after onset ]
    mean value of change of PTA in each participant at 1 month 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).
  • Change of Pure Tone Audiometry(PTA) at 2 months after onset [ Time Frame: 2 months after onset ]
    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).
  • Change of subjective complaint of vertigo/dizziness from baseline at 1-month follow-up after onset. [ Time Frame: 1 month after onset ]
    The number of participants who complain of vertigo/dizziness disappeared, still exist but improved, no change/worsening compared with baseline at 1-month follow-up after onset.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prognosis of Vestibular Dysfunction in Patients With Idiopathic Sudden Sensorineural Hearing Loss
Official Title Prognosis of Vestibular Dysfunction in Patients With Idiopathic Sudden Sensorineural Hearing Loss
Brief Summary Idiopathic sudden sensorineural hearing loss (ISSNHL) refers to idiopathic sensorineural hearing loss of at least 30 dB over at least three test frequencies occurring over a 72-hour period. Vertigo has been considered a risk factor of poor prognosis in patients with ISSNHL. However, the clinical outcome and development of vestibular function in these patients have not been reported yet. We'd like to conduct a study on the problem whether these patients resulted in a complete recovery of the peripheral vestibular functions or compensation of the central vestibular system. If the answer is the former one, these cases might be supportive evidence of regeneration of hair cells in vestibular disorders.
Detailed Description This study is designed as a prospective cohort study with only one cohort. Enrolment and data collection are performed by trained research staff who are not involved in the care of the patients. The primary measurement is the vestibular function tests including SOT, the caloric reflex test, vHIT, VEMP (cVEMP and oVEMP). The secondary measurements included PTA, DHI, and VAS. The sample size was set at 60 patients. The continuous variables were expressed as means ± standard deviation (SD) whereas categorical variables were expressed as frequency and percentage for data description. P <0.05 was considered statistically significant.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients who suffered from ISSNHL with vertigo and the onset of this disease was within 30 days, will be included in this study cohort. The enrollment of the participants will be held in the clinic of Eye and ENT Hospital of Fudan University.
Condition
  • Vestibular Disorder
  • Sudden Hearing Loss
Intervention Other: ISSNHL with vertigo
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.
Study Groups/Cohorts 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.
Intervention: Other: ISSNHL with vertigo
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. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 14, 2019) 		60
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2021
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Younger than 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.
Sex/Gender
Sexes Eligible for Study: All
Ages up to 70 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Huiqian Yu, Phd & MD 8613636423139 yhq925@163.com
Contact: Weiming Hao, MD 8613761816819 wmhao12@fudan.edu.cn
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03951584
Other Study ID Numbers Cohort ISSNHL with vertigo
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Eye & ENT Hospital of Fudan University
Study Sponsor Eye & ENT Hospital of Fudan University
Collaborators Not Provided
Investigators
Study Chair: Huawei Li, Phd & MD Eye and ENT Hospital of Fudan University
PRS Account Eye & ENT Hospital of Fudan University
Verification Date February 2020

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