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

Eye & ENT Hospital of Fudan University

Status: Completed

Conditions: Sudden Hearing Loss; Vestibular Disorder

Treatments: Other: ISSNHL with vertigo

Study type: Observational

Funder types: Other

Identifiers

NCT03951584

Cohort ISSNHL with vertigo

Details and patient eligibility

About

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.

Full 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.

Enrollment: 86 patients

Sex: All

Ages: 16 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

86 participants in 1 patient group

ISSNHL with vertigo

Description:

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.

Treatment:

Other: ISSNHL with vertigo