NCT03431506

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2018

Completed
28 days until next milestone

First Posted

Study publicly available on registry

February 13, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
Last Updated

February 13, 2018

Status Verified

February 1, 2018

Enrollment Period

1.5 years

First QC Date

January 16, 2018

Last Update Submit

February 11, 2018

Conditions

Vestibular Disorder

Outcome Measures

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)

    before treatment

Secondary Outcomes (2)

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

    2 weeks after treatment

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

    2 months after treatment

Study Arms (2)

non-training group

ACTIVE COMPARATOR
Behavioral: Vestibular rehabilitation

training group

EXPERIMENTAL
Behavioral: Vestibular rehabilitation

Interventions

Vestibular rehabilitationBEHAVIORAL

Vestibular Rehabilitation Exercises

non-training grouptraining group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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;
  • Within 10 days from onset;
  • Without other virus infectious disease within three months.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200031, China

RECRUITING

MeSH Terms

Conditions

Vestibular Diseases

Condition Hierarchy (Ancestors)

Labyrinth DiseasesEar DiseasesOtorhinolaryngologic Diseases

Central Study Contacts

Huawei Li, Phd &MD

CONTACT

+86-13636423139huaweili2000@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2018

First Posted

February 13, 2018

Study Start

December 1, 2017

Primary Completion

May 30, 2019

Study Completion

December 30, 2019

Last Updated

February 13, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)