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

NCT03951584 | Completed DMC

• 1 other identifier: Cohort ISSNHL with vertigo
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Vestibular Disorder; Sudden Hearing Loss

Keywords

idiopathic sudden sensorineural hearing loss; vestibular dysfunction

Outcome Measures

Primary Outcomes (10)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (3)

• Change of Dizziness Handicap Inventory at 2 months after onset

  2 months after onset

• Change of Visual Analogue Scale in Vertigo at 2 month after onset

  2 months after onset

• Change of Pure Tone Audiometry(PTA) at 2 months after onset

  2 months after onset

Study Arms (1)

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

Interventions

ISSNHL with vertigo OTHER

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.

ISSNHL with vertigo

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eye & ENT Hospital of Fudan University: lead

Study Sites (1)

Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University, Shanghai, China

Shanghai, Shanghai Municipality, 200031, China

Location

Related Publications (5)

• 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.

  PMID: 22383545 BACKGROUND

• 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.

  PMID: 23771280 BACKGROUND

• 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.

  PMID: 29931169 BACKGROUND

• 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.

  PMID: 18716300 BACKGROUND

• Hao W, Ye L, Yu H, Li H. Prognosis of vestibular dysfunction in idiopathic sudden sensorineural hearing loss with vertigo: a prospective cohort study. J Neurol. 2023 Nov;270(11):5516-5526. doi: 10.1007/s00415-023-11894-w. Epub 2023 Jul 30.

  PMID: 37517037 DERIVED

MeSH Terms

Conditions

Vestibular Diseases; Hearing Loss, Sudden

Condition Hierarchy (Ancestors)

Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Hearing Loss; Hearing Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Huawei Li, Phd & MD

  Eye and ENT Hospital of Fudan University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2019
• First Posted: May 15, 2019
• Study Start: May 15, 2019
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: November 4, 2022

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR

Locations

CN (1)