Clinical trial NCT03951584: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vestibular Disorder
Sudden Hearing Loss
Keywords: idiopathic sudden sensorineural hearing loss
vestibular dysfunction
Lead sponsor: Eye & ENT Hospital of Fudan University
Sponsor class: OTHER
First posted: 2019-05-15
Enrollment: 86
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Abnormal rate of vestibular function in the Sensory Organization Test(SOT) at baseline.
timeFrame: Baseline
measure: Recovery rate of vestibular input in the Sensory Organization Test(SOT) at 2-months follow-up after onset.
timeFrame: 2 months after onset
measure: Abnormal rate of the caloric test at baseline.
timeFrame: Baseline
measure: Recovery rate of the caloric test at 2-months follow-up after onset.
timeFrame: 2 months after onset
measure: Abnormal rate of the vHIT at baseline.
timeFrame: Baseline
measure: Recovery rate of the vHIT at 2-months follow-up after onset.
timeFrame: 2 months after onset
measure: Abnormal rate of Cervical Vestibular Evoked Myogenic Potentials (cVEMP) at baseline.
timeFrame: Baseline
measure: Recovery rate of Cervical Vestibular Evoked Myogenic Potentials (cVEMP) at 2-months follow-up after onset.
timeFrame: 2 months after onset
measure: Abnormal rate of Ocular Vestibular Evoked Myogenic Potentials (oVEMP) at baseline.
timeFrame: Baseline
measure: Recovery rate of Ocular Vestibular Evoked Myogenic Potentials (oVEMP) at 2-months follow-up after onset.
timeFrame: 2 months after onset
Secondary outcomes:
measure: Change of Dizziness Handicap Inventory at 2 months after onset
timeFrame: 2 months after onset
measure: Change of Visual Analogue Scale in Vertigo at 2 month after onset
timeFrame: 2 months after onset
measure: Change of Pure Tone Audiometry(PTA) at 2 months after onset
timeFrame: 2 months after onset
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University, Shanghai, China
state: Shanghai
Study officials:
affiliation: Eye and ENT Hospital of Fudan University
name: Huawei Li, Phd & MD
role: STUDY_CHAIR
References:
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.
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.
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.
citation: 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.