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Status unknownNCT03431506Updated Feb 13, 2018

Vestibular Function and Vestibular Rehabilitation in SSHL With Vertigo

An interventional study of Vestibular rehabilitation in Vestibular Disorder, sponsored by Eye & ENT Hospital of Fudan University. Status unknown at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2018-02-13.

Sponsored by Eye & ENT Hospital of Fudan University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

To evaluate the vestibular function and vestibular rehabilitation in sudden sensorneural hearing loss(SSHL) with vertigo

Read the detailed description

Approximately 5-20 per 100,000 persons are afflicted with SSHL annually, and nearly 20-60% of SSHL patients complain of simultaneous vertigo.The aim of this study was to evaluate the prevalence of vestibulocochlear lesions in sudden sensorneural hearing loss(SSHL) with vertigo, as well as the role of vestibular rehabilitation in the prognosis of SSHL with vertigo.

02

Conditions studied

  • Vestibular Disorder

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03

In context

Vestibular Diseases

170 studies on the registry are indexed under Vestibular Diseases; 41 are open to participants now.

This study's planned enrollment of 80 is above the median of 46 across 127 interventional studies indexed under Vestibular Diseases.

Browse Vestibular Diseases studies →

Lead sponsor

Eye & ENT Hospital of Fudan University is the lead sponsor of 126 studies on the registry; 70 are open to participants now.

Browse Eye & ENT Hospital of Fudan University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. A rapid onset sensorineural hearing loss of more than 30 dB for at least three contiguous audiometric frequencies within a period of 3 days, according to standard AAO - HNS;
  2. Within 10 days from onset;
  3. Without other virus infectious disease within three months.

Exclusion criteria

Exclusion Criteria:

  1. BPPV; Meniere's disease and vestibular migraine.
  2. With certain Known etiology, including acoustic neuroma, heart cerebrovascular accident, injury, Hunt syndrome, etc
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Double (Care provider, Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Active comparator
    non-training group

    Behavioral: Vestibular rehabilitation

  • Experimental
    training group

    Behavioral: Vestibular rehabilitation

Interventions

  • BehavioralVestibular rehabilitation

    Vestibular Rehabilitation Exercises

06

What researchers measure

Primary outcomes

  1. Assessment of vestibular function status by vestibular function tests in SSHL with vertigo at stage 1(before treatment)

    Vestibular function status in SSHL with vertigo at stage 1(before treatment)

    Time frame: before treatment

Secondary outcomes

  1. Assessment of vestibular function status by vestibular function tests in SSHL with vertigo at stage 2(2 weeks after treatment)

    Vestibular function status in SSHL with vertigo at stage 2(2 weeks after treatment)

    Time frame: 2 weeks after treatment

  2. Assessment of vestibular function status by vestibular function tests in SSHL with vertigo at stage 2(2 months after treatment)

    Vestibular function status in SSHL with vertigo at stage 2(2 months after treatment)

    Time frame: 2 months after treatment

07

Study locations

1 of 1 sites recruiting
  • Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University, Shanghai, China
    Shanghai, Shanghai 200031, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2017 (actual). Primary completion is estimated for May 2019, 17 months after the start.

Of 79 non-industry interventional studies with no phase under Vestibular Diseases, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 37. This study's planned 17 months is close to that.

Counting every sponsor, half of 84 studies reached it within 15 months; a quarter within 8 and three quarters within 34.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 16, 2018
First posted
Feb 13, 2018
StartActual
Dec 1, 2017
Primary completionEst.
May 30, 2019
CompletionEst.
Dec 30, 2019
Last update
Feb 13, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 13, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03431506
Lead sponsor
Eye & ENT Hospital of Fudan University
Responsible party
Sponsor
First posted
Feb 13, 2018
Start date
Dec 1, 2017
Primary completion
May 30, 2019 (estimated)
Completion
Dec 30, 2019 (estimated)
Last update
Feb 13, 2018

Study contacts

Huawei Li, Phd &MD
Contact
huaweili2000@163.com
+86-13636423139

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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