NCT06143462

Brief Summary

To investigate the efficacy of vestibular rehabilitation treatment on unsteadiness after intratympanic gentamicin in patients with Meniere's disease.

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
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 22, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

November 22, 2023

Status Verified

November 1, 2023

Enrollment Period

6 months

First QC Date

November 16, 2023

Last Update Submit

November 16, 2023

Conditions

Vestibular Disorder

Outcome Measures

Primary Outcomes (1)

  • Functional Gait Assessment (FGA)

    FGA is a semi-quantitative measure of walking balance ability.

    Change from baseline, at 8 weeks and 6 months post-randomization

Secondary Outcomes (4)

  • Sensory Organization Test (SOT)

    Change from baseline, at 8 weeks and 6 months post-randomization

  • Meniere's Disease Outcomes Questionnaire (MDOQ)

    Change from baseline, at 8 weeks and 6 months post-randomization

  • Visual Vertigo Analogue Scale (VVAS)

    Change from baseline, at 8 weeks and 6 months post-randomization

  • Vestibular Activities and Participation Measure (VAP)

    Change from baseline, at 8 weeks and 6 months post-randomization

Study Arms (2)

Group A: usual care (UC)

ACTIVE COMPARATOR

Group A (UC) will receive conventional medications.

Drug: Usual careOther: Health Education

Group B: vestibular rehabilitation treatment (VRT)

EXPERIMENTAL

Group B (VRT) will receive outpatient VRT in combination with home practice based on conventional treatment.

Behavioral: vestibular rehabilitation

Interventions

Usual careDRUG

Include anti-dizziness medications, diuretics, or hormone therapy.

Group A: usual care (UC)
Health EducationOTHER

Include comprehensive health education, fall prevention and lifestyle adjustments.

Group A: usual care (UC)
vestibular rehabilitationBEHAVIORAL

Encompass office-based sessions of vestibular rehabilitation treatment once weekly, supplemented by home-based exercises conducted two or three times daily for the remaining duration of the study.

Group B: vestibular rehabilitation treatment (VRT)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged between 18 and 75 years old;
  • Complained of persistent unsteadiness 1 month after intratympanic gentamicin treatment;
  • Be willing to sign the informed consent of the study.

You may not qualify if:

  • Conformed to neuromuscular disease;
  • Conformed to severe cervical spine disease;
  • Conformed to congenital inner ear disease (except vestibular migraine(VM))
  • Concurrent manifestation of psychiatric or psychological disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University

Shanghai, Shanghai Municipality, 200031, China

Location

Related Publications (1)

  • Tong Q, Zhou Y, Wu P, Yu H. Effect of vestibular rehabilitation treatment (VRT) on patients with unsteadiness after intratympanic gentamicin in Meniere's disease: protocol for a randomised controlled trial. BMJ Open. 2025 Feb 22;15(2):e088722. doi: 10.1136/bmjopen-2024-088722.

    PMID: 39987011DERIVED

MeSH Terms

Conditions

Vestibular Diseases

Condition Hierarchy (Ancestors)

Labyrinth DiseasesEar DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Huiqian Yu

    Eye and ENT Hospital of Fudan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Huiqian Yu

CONTACT

13636423139yhq925@163.com

Qiling Tong

CONTACT

1381652017923211260026@m.fudan.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2023

First Posted

November 22, 2023

Study Start

January 1, 2024

Primary Completion

June 30, 2024

Study Completion

December 31, 2024

Last Updated

November 22, 2023

Record last verified: 2023-11

Locations

CN(1)