| CTRI Number |
CTRI/2024/06/068492 [Registered on: 06/06/2024] Trial Registered Prospectively |
| Last Modified On: |
16/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Analysis of VNG test in giddiness patients. |
|
Scientific Title of Study
|
Analysis of Videonystagmography findings of Balance disorder patients who do not have Benign paroxysmal positional vertigo in a tertiary health care centre. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr.M.Muhunthan |
| Designation |
Junior Resident |
| Affiliation |
MAHE |
| Address |
Department of ORL HNS , 4th floor , New OPD block , KMC manipal , Manipal , Madhav Nagar , Eeshwar Nagar , Udupi , Karnataka 576101.
Udupi
KARNATAKA
576101
India |
| Phone |
8940193663 |
| Fax |
|
| Email |
muhunthan.kmcmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Kailesh Pujary |
| Designation |
Professor and HOD |
| Affiliation |
MAHE |
| Address |
Department of ORL HNS , 4th floor , New OPD block , KMC manipal , Manipal , Madhav Nagar , Eeshwar Nagar , Udupi , Karnataka 576101.
Udupi
KARNATAKA
576101
India |
| Phone |
9845144015 |
| Fax |
|
| Email |
kailesh.pujary@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr.M.Muhunthan |
| Designation |
Junior Resident |
| Affiliation |
MAHE |
| Address |
Department of ORL HNS , 4th floor , New OPD block , KMC manipal , Manipal , Madhav Nagar , Eeshwar Nagar , Udupi , Karnataka 576101.
Udupi
KARNATAKA
576101
India |
| Phone |
8940193663 |
| Fax |
|
| Email |
muhunthan.kmcmpl2023@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| KMC manipal , Manipal , Madhav Nagar , Eeshwar Nagar , Udupi , Karnataka 576101. |
|
|
Primary Sponsor
|
| Name |
Institutional Ethics Committee, MAHE, Manipal |
| Address |
KMC manipal , Manipal , Madhav Nagar , Eeshwar Nagar , Udupi , Karnataka 576101. |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Institutional Ethics Committee MAHE Manipal |
KMC manipal , Manipal , Madhav Nagar , Eeshwar Nagar , Udupi , Karnataka 576101. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrKailesh Pujary |
Kasturba hospital, Manipal |
Department of ORL HNS , 4th floor , New OPD block , KMC manipal , Manipal , Madhav Nagar , Eeshwar Nagar , Udupi , Karnataka 576101.
Udupi
KARNATAKA |
9845144015
ent.kmc@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturbaa Medical College and Kasturba Hospital Intstitutional Ethics committee 2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H810||Menieres disease, (2) ICD-10 Condition: H818||Other disorders of vestibular function, (3) ICD-10 Condition: H813||Other peripheral vertigo, (4) ICD-10 Condition: H819||Unspecified disorder of vestibularfunction, (5) ICD-10 Condition: H814||Vertigo of central origin, (6) ICD-10 Condition: H812||Vestibular neuronitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with Vertigo
2. Age group - 18-80 .
3. Patients who have negative Dix- Hallpike test .
|
|
| ExclusionCriteria |
| Details |
1. Patient diagnosed with significant defective vision .
2. Diagnosed neurological disorders which interfere with oculomotor pathway like multiple sclerosis .
3.patients who are easily triggerred by flashing lights inducing epilepsy .
4.Patients with cervial spinal abnormalities .
5. Patients who have cardiological , (postural hypotension , arrhythmia ) or psychological conditions (anxiety depression).
6. Patients who have perforations in their Tympanic Membrane .
|
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To measure variations in slow phase velocity of spontaneous nystagmus, gaze evoked and positional evoked nystagmus.Gains of Saccade , Slow phase velocity , optokinetic nystagmus. Canal paresis and directional preponderance. |
At the time of examination or initial patient presentation.
At the time of complete complete diagnosis.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Provisional diagnosis before VNG
Provisional diagnosis after VNG
Percentage of Change in diagnosis after the VNG |
At the time of initial patient presentation.
After doing VNG |
|
|
Target Sample Size
|
Total Sample Size="95"
Sample Size from India="95"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/06/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [muhunth058@gmail.com].
- For how long will this data be available start date provided 01-01-2027 and end date provided 01-01-2031?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
To assess the Videonystagmographic findings of vertigo patients who don’t have BPPV in indian population. To recognize or any patterns in VNG which are specific to non BPPV patients.
VNG is a comparatively new modality of Vestibular testing for which we have less data available among indian population. This study aims to bridge that gap .
By scrutinizing such a test which is noninvasive , there might be new scenarios where this test can be used apart from what it is currently being used for.
|