NCT04791930

Brief Summary

To evaluate the function of vestibular system in patients with chronic suppurative otitis media safe type.

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
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2021

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

February 9, 2021

Completed
29 days until next milestone

First Posted

Study publicly available on registry

March 10, 2021

Completed
8 months until next milestone

Study Start

First participant enrolled

October 28, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

March 10, 2021

Status Verified

March 1, 2021

Enrollment Period

1.5 years

First QC Date

February 9, 2021

Last Update Submit

March 9, 2021

Conditions

Vertigo Labyrinthine

Keywords

Chronic suppurative otitis mediasafe typevertigovestibular testingvestibular functionVNGRotatory Chair

Outcome Measures

Primary Outcomes (1)

  • Vestibular evaluation

    The incidence and extent of vestibular dysfunction in patients with chronic suppurative otitis media: safe type

    Baseline

Eligibility Criteria

Age10 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

patients with chronic suppurative otitis media safe type.

You may qualify if:

  • Age: from 10 years to 45 years old.
  • Sex: male or female.
  • Safe type Chronic Suppurative Otitis Media.

You may not qualify if:

  • Un safe type Chronic Suppurative Otitis Media.
  • Noise exposure and heredofamilial hearing loss.
  • Adhesive process or history of ear surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assuit University

Asyut, Egypt

RECRUITING

Related Publications (1)

  • Monsanto RDC, Kasemodel ALP, Tomaz A, Elias TGA, Paparella MM, Penido NO. Evaluation of vestibular symptoms and postural balance control in patients with chronic otitis media. J Vestib Res. 2020;30(1):35-45. doi: 10.3233/VES-200691.

    PMID: 32083607BACKGROUND

MeSH Terms

Conditions

Vertigo

Condition Hierarchy (Ancestors)

Vestibular DiseasesLabyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Enass sayed Mohamed, Professor

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed Ahmed Abd Elhameed Ali

CONTACT

01065276753dr.mohamed.ammar93@gmail.com

Mohamed Mohamed Elmoursy, Lecturer

CONTACT

01003615648

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

February 9, 2021

First Posted

March 10, 2021

Study Start

October 28, 2021

Primary Completion

April 28, 2023

Study Completion

October 1, 2023

Last Updated

March 10, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will share

Locations

EG(1)