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

Vestibular Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03951584
• Other study ID #: Cohort ISSNHL with vertigo
• Status: Completed
• Start date: May 15, 2019
• Est. completion date: May 1, 2022

Study information

• Verified date: February 2020
• Source: Eye & ENT Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: May 1, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Hearing Loss, Sensorineural
• Hearing Loss, Sudden
• Sudden Hearing Loss
• Vestibular Diseases
• Vestibular Disorder

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.

Locations

Country	Name	City	State
China	Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University, Shanghai, China	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. Clinical practice. Idiopathic sudden sensorineural hearing loss. N Engl J Med. 2008 Aug 21;359(8):833-40. doi: 10.1056/NEJMcp0802129. Review. — 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

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. — 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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abnormal rate of vestibular function in the Sensory Organization Test(SOT) at baseline.	abnormal rate=(number of participants who have abnormal results in vestibular function in SOT at the baseline)/(number of participants in total)	Baseline
Primary	Recovery rate of vestibular input in the Sensory Organization Test(SOT) at 2-months follow-up 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)	2 months after onset
Primary	Abnormal rate of the caloric test at 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%.	Baseline
Primary	Recovery rate of the caloric test at 2-months follow-up 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%.	2 months after onset
Primary	Abnormal rate of the vHIT at 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.	Baseline
Primary	Recovery rate of the vHIT at 2-months follow-up 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.	2 months after onset
Primary	Abnormal rate of Cervical Vestibular Evoked Myogenic Potentials (cVEMP) at 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.	Baseline
Primary	Recovery rate of Cervical Vestibular Evoked Myogenic Potentials (cVEMP) at 2-months follow-up 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.	2 months after onset
Primary	Abnormal rate of Ocular Vestibular Evoked Myogenic Potentials (oVEMP) at 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.	Baseline
Primary	Recovery rate of Ocular Vestibular Evoked Myogenic Potentials (oVEMP) at 2-months follow-up 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.	2 months after onset
Secondary	Change of Dizziness Handicap Inventory at 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.)	2 months after onset
Secondary	Change of Visual Analogue Scale in Vertigo at 2 month 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.	2 months after onset
Secondary	Change of Pure Tone Audiometry(PTA) at 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).	2 months after onset