| CTRI Number |
CTRI/2021/02/031143 [Registered on: 09/02/2021] Trial Registered Prospectively |
| Last Modified On: |
09/10/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Effect of regular noise exposure on the balance function of the inner ear and the burden of balance dysfunction due to regular noise exposure among the traffic police personnel and automobile drivers. |
|
Scientific Title of Study
|
Effect of chronic noise exposure on the vestibular function and the burden of vestibular dysfunction due to chronic noise exposure among the traffic police personnel and automobile drivers. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Soumyajit Das |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences, Mangalagiri |
| Address |
Department of ENT,
OPD Block, 1st Floor
All India Institute of Medical Sciences, Mangalagiri,
Old TB Sanatorium Road;
Guntur ANDHRA PRADESH 522503 India |
| Phone |
9864371311 |
| Fax |
|
| Email |
drsoumya_entamch@rediffmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Soumyajit Das |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences, Mangalagiri |
| Address |
Department of ENT,
OPD Block, 1st Floor
All India Institute of Medical Sciences, Mangalagiri,
Old TB Sanatorium Road;
Guntur ANDHRA PRADESH 522503 India |
| Phone |
9864371311 |
| Fax |
|
| Email |
drsoumya_entamch@rediffmail.com |
|
Details of Contact Person Public Query
|
| Name |
Soumyajit Das |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences, Mangalagiri |
| Address |
Department of ENT,
OPD Block, 1st Floor
All India Institute of Medical Sciences, Mangalagiri,
Old TB Sanatorium Road;
Guntur ANDHRA PRADESH 522503 India |
| Phone |
9864371311 |
| Fax |
|
| Email |
drsoumya_entamch@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Health Research/Indian Council of Medical Research, New Delhi |
|
|
Primary Sponsor
|
| Name |
DHR ICMR |
| Address |
V. Ramalingaswamy Bhawan,
P.O.Box No 4911,
Ansari Nagar,
New Delhi - 110029 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrSoumyajit Das |
All India Institute of Medical Sciences, Mangalagiri |
Department of ENT,
OPD Block, 1st Floor, Room 119
All India Institute of Medical Sciences, Mangalagiri
Old TB Sanatorium Road;
Guntur ANDHRA PRADESH |
9864371311
drsoumya_entamch@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC,AIIMS,Mangalagiri |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Vestibular function |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Exposed group:
1.All individuals within 25 -50 years of age
group
2.Traffic policemen and automobile drivers
working in a noisy environment for atleast
5 hours per day for the last 5 years or
more.
3.No history of any vestibular crisis in
the past.
4.Persons willing to undergo complete
vestibular evaluation tests.
For Non exposed group:
1.Healthy volunteers within 25 – 50 years age
2.Not exposed to any form of acute or
chronic noise exposure
|
|
| ExclusionCriteria |
| Details |
1.Non consent
2.Known case of anemia, diabetes, hypertension,
hypothyroidism ,cardiac ailment and or
chronic kidney disease.
3.Known case of vestibular dysfunction
4.Individuals with history of Tullio
phenomenon in the past.
5.Known case of Psychiatric disorders
6.Persons who have taken vestibular
suppressant medications.
|
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
|
Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
| Vestibular functions |
at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Burden of vestibular dysfunction in noise exposed |
at baseline |
|
|
Target Sample Size
|
Total Sample Size="242" Sample Size from India="242"
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)
|
15/02/2021 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Introduction:
Noise
pollution is an
important health hazard
and affects the
hearing threshold in chronic exposure. There are
various non-auditory effects
of chronic noise
exposure which can
affect the cardiovascular system, sleep
pattern and cognitive
function (Basner, et al. 2014). The
balance system though
functionally independent from
the auditory system
is intricately embedded
within the bony
labyrinth of the
inner ear and
has complex neural
network that connect
the peripheral receptors
with the higher
centres. The saccule which
is a part
of the balance
system has been found
to respond to
sound and plays
a key role
in the equilibrium. There are
concerns that chronic
noise exposure can
affect the vestibular system.
Traffic policemen and
automobile drivers are
exposed to high
noise levels. Unlike
industrial workers where
there are regulations
on the safe
noise levels and
usage of noise
prevention strategies, traffic
policemen and automobile
workers are exposed
to unregulated levels
of noise exposure
during their daily
activities. Further the
effect of noise in the
vestibular function on
these group has
not been studied.
Vestibular dysfunction if
any in these
group can be
dangerous and have
widespread implications in
the routine performance
of daily activities.
Hence the need
for this present
study. Research Question : 1 Does noise exposure affect the vestibular function? 2. What is the burden of the vestibular dysfunction due to chronic noise exposure? The aims
and objectives of the study
are:
- 1. To
compare the vestibular function between noise exposed and
controls by estimating the latency and
amplitude of the Vestibular evoked myogenic potentials ( VEMP)
- 2. To determine the effect of chronic
noise exposure on dynamic
posturography.
- 3. To determine the effect
of chronic noise
exposure on the
caloric function during videonystagmography (VNG)
- 4. To determine the effect of
chronic noise exposure
on the vestibulo-ocular reflex (VOR).
- 5. To estimate the burden of
vestibular dysfunction due
to chronic noise
exposure among the
study group.
Expected outcome
of the study: - 1. We will
be able to
find out whether
chronic noise exposure has
any effect on
the vestibular system.
- 2. We will
be able to
identify the noise
level , and the
duration of exposure
at which such
changes take place.
- 3. There can
be far reaching effect
in regularizing the
safe level of
noise at workplace.
- 4. It will
be possible to
take preventive measures to
prevent noise induced vestibular
dysfunction.
- 5. We will
be able to
estimate the burden
of vestibular dysfunction in
chronic noise exposure.
Novelty:
The
effect of noise
exposure on the
auditory system is
well documented. However
the long term
effect of the
noise exposure on
the vestibular system
is not conclusive
and most of
the studies have evaluated
the vestibular system
in presence of noise
induced hearing loss. Moreover
such studies in the Indian population
are lacking. There
are no studies
done on the
traffic policemen and
automobile drivers who
are vulnerable to
chronic noise exposure
and where vestibular
dysfunction can have
serious implications in the day
to day discharge
of duties. Further early
changes get compensated
and may not
manifest as vestibular
dysfunction. It is
not clear which
part of the
vestibular function is
actually affected and
whether the changes
are temporary or
permanent. Our study aim to
evaluate the vestibular
function in cases
of chronic noise
exposure and also
find the levels
of noise exposure
at which such
changes occur. This
can have a
far reaching effect
in regularizing the
safe sound levels
at workplace and
lead to better
occupational health by
minimizing or avoiding
the hazards of
noise pollution.
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