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NCT Number: NCT03951584

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

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.

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Key information

Conditions

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

Age range

16 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Shanghai, Shanghai Municipality, 200031, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: Baseline

    abnormal rate=(number of participants who have abnormal results in vestibular function in SOT at the baseline)/(number of participants in total)

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

    Time frame: 2 months 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)

  3. Abnormal rate of the caloric test at baseline.

    Time frame: 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%.

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

    Time frame: 2 months 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%.

  5. Abnormal rate of the vHIT at baseline.

    Time frame: 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.

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

    Time frame: 2 months 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.

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

    Time frame: 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.

  8. Recovery rate of Cervical Vestibular Evoked Myogenic Potentials (cVEMP) at 2-months follow-up after onset.

    Time frame: 2 months 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.

  9. Abnormal rate of Ocular Vestibular Evoked Myogenic Potentials (oVEMP) at baseline.

    Time frame: 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.

  10. Recovery rate of Ocular Vestibular Evoked Myogenic Potentials (oVEMP) at 2-months follow-up after onset.

    Time frame: 2 months 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.

Secondary outcomes

  1. Change of Dizziness Handicap Inventory at 2 months after onset

    Time frame: 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. Change of Visual Analogue Scale in Vertigo at 2 month after onset

    Time frame: 2 months 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.

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

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Eye & ENT Hospital of Fudan University

Other

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
May 15, 2019
Registry last updated
Nov 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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