Back to results

Vestibular Rehabilitation With Intratympanic Drug Therapy in Meniere's Disease

Primary Purpose

Vestibular Disorder Preservation

Status

Recruiting

Phase

Not Applicable

Locations

Pakistan

Study Type

Interventional

Intervention

Gentamicin

Dexamethasone

About this trial

This is an interventional treatment trial for Vestibular Disorder Preservation focused on measuring dexamethasone, gentamicin

Eligibility Criteria

24 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

All patients of unilateral Meniere's disease with severe vestibular symptoms

Exclusion Criteria:

Bilateral disease, operated cases

Sites / Locations

CMH QuettaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vestibular severity index improvement

Arm Description

Improvement in vestibular symptoms with intratympanic gentamicin

Outcomes

Primary Outcome Measures

Vestibular Rehabilitation

Improvement in vestibular severity index

Secondary Outcome Measures

Full Information

NCT ID

NCT05355610

First Posted

April 24, 2022

Last Updated

April 27, 2022

Sponsor

Combined Military Hospital Quetta

1. Study Identification

Unique Protocol Identification Number

NCT05355610

Brief Title

Vestibular Rehabilitation With Intratympanic Drug Therapy in Meniere's Disease

Official Title

Objective Vestibular Evaluation & Rehabilitation With Intratympanic Dexamethasone and Gentamicin in Meniere's Disease

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Recruiting

Study Start Date

April 1, 2021 (Actual)

Primary Completion Date

April 22, 2022 (Actual)

Study Completion Date

May 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Combined Military Hospital Quetta

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Intractable symptoms of Meniere's disease will be treated with intratympanic steroids. At the same time intratympanic dexamethasone will be used to rescue hearing

Detailed Description

For Alleviation of Intractable symptoms of Meniere's disease will be treated with intratympanic steroids. Measured with pre and post therapy vestibular severity index. At the same time intratympanic dexamethasone will be used to rescue hearing measured with speech reception threshold and speech discrimination threshold

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vestibular Disorder Preservation

Keywords

dexamethasone, gentamicin

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Patients with unilateral Meniere's disease with intractable vertigo will be administered two doses of intratympanic gentamicin plus dexamethasone 1 week apart

Masking

None (Open Label)

Masking Description

Allocation

N/A

Enrollment

93 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Vestibular severity index improvement

Arm Type

Experimental

Arm Description

Improvement in vestibular symptoms with intratympanic gentamicin

Intervention Type

Drug

Intervention Name(s)

Gentamicin

Other Intervention Name(s)

Intratympanic gentamicin

Intervention Description

Intratympanic gentamicin and dexamethasone administered in two doses one week apart

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Other Intervention Name(s)

Intratympanic dexamethasone

Intervention Description

Intratympanic gentamicin and dexamethasone administered in two doses one week apart

Primary Outcome Measure Information:

Title

Vestibular Rehabilitation

Description

Improvement in vestibular severity index

Time Frame

Three months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

24 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: All patients of unilateral Meniere's disease with severe vestibular symptoms Exclusion Criteria: Bilateral disease, operated cases

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Zeeshan Ayub, FCPS

Phone

+923215233648

zeeshanent@yahoo.com

First Name & Middle Initial & Last Name or Official Title & Degree

Zeeshan Ayub, FCPS

Phone

03215233648

zeeshanent@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zeeshan Ayub, FCPS

Organizational Affiliation

CMH Quetta

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Zeeshan Ayub, FCPS

Organizational Affiliation

CMH Quetta

Official's Role

Study Chair

Facility Information:

Facility Name

CMH Quetta

City

Quetta

State/Province

Balochistan

ZIP/Postal Code

87300

Country

Pakistan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zeeshan Ayub, FCPS

Phone

+923215233648

First Name & Middle Initial & Last Name & Degree

Azeema Ahmed, FCPS

Phone

+923325222335

azeemazeeshan1980@gmail.com

12. IPD Sharing Statement

Learn more about this trial

Vestibular Rehabilitation With Intratympanic Drug Therapy in Meniere's Disease

We'll reach out to this number within 24 hrs