CompletedNot Applicable

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

China86 participantsStarted 2019-05-15

Plain-language 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.

Who can participate

Age range

16 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Abnormal rate of vestibular function in the Sensory Organization Test(SOT) at baseline.

Timeframe: Baseline

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

Timeframe: 2 months after onset

Abnormal rate of the caloric test at baseline.

Timeframe: Baseline

Recovery rate of the caloric test at 2-months follow-up after onset.

Timeframe: 2 months after onset

Abnormal rate of the vHIT at baseline.

Timeframe: Baseline

Recovery rate of the vHIT at 2-months follow-up after onset.

Timeframe: 2 months after onset

Abnormal rate of Cervical Vestibular Evoked Myogenic Potentials (cVEMP) at baseline.

Timeframe: Baseline

Trial details

NCT IDNCT03951584

SponsorEye & ENT Hospital of Fudan University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-05-01

View on ClinicalTrials.gov More Vestibular Disorder trials

Plain-language summary

Who can participate

Age range

16 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Abnormal rate of vestibular function in the Sensory Organization Test(SOT) at baseline.

Timeframe: Baseline

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

Timeframe: 2 months after onset

Abnormal rate of the caloric test at baseline.

Timeframe: Baseline

Recovery rate of the caloric test at 2-months follow-up after onset.

Timeframe: 2 months after onset

Abnormal rate of the vHIT at baseline.

Timeframe: Baseline

Recovery rate of the vHIT at 2-months follow-up after onset.

Timeframe: 2 months after onset

Abnormal rate of Cervical Vestibular Evoked Myogenic Potentials (cVEMP) at baseline.

Timeframe: Baseline