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Clinical Trials/CTRI/2023/08/056957
CTRI/2023/08/056957Not yet recruitingNot Applicable

Influence of Recreational Noise Exposure on Cochlear Synaptic Functions in College-Going Students

Michal Jacob1 site in 1 country132 target enrollmentStarted: January 9, 2023Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
132
Locations
1
Primary Endpoint
NESI- total units of noise exposure,

Study Overview

Brief Summary

Aim: To study the influence of recreational noise exposure on cochlear synaptic functions in college-going students.

Objectives:

  1. To estimate the recreational noise exposure levels
  2. To assess the influence of recreational noise on ABR wave I latency, amplitude and FFR
  3. To study the association between recreational noise exposure and ABR and FFR

Justification for study: Listening difficulty and poor speech perception is common in cochlear synaptopathy, which is also reported by chronic recreational noise exposure individuals. However, till date the relationship is not established. Hence there is a need to see the influence and association of recreational noise and synaptic function.

Procedure: This study involves the administration of the Noise Exposue Structured Interview (Guest et al, 2018) to estimate a person’s lifetime noise exposure. After this individuals are grouped into 3 groups. Group 1- No noise/ occasional users of PLDs or recreational noise exposure, 2- Predominant PLD users, 3- Combined PLD and recreational noise exposure. Then Pure Tone Audiometry along with Extended High Frequency Audiometry and Speech-in-noise test are done. Otoacoustic emissions, Electrocochleography, ABR and Frequency Following Response will also be done.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 30.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • College going students between 18-30 years of age.

Exclusion Criteria

  • Individuals with middle ear problems.
  • Pre-existing hearing loss.
  • Neurological or medical conditions that influence auditory and cognitive functions.

Outcomes

Primary Outcomes

NESI- total units of noise exposure,

Time Frame: 11 months 19 days

Electrophysiological measure -Amplitude (microvolt) / latency of wave I (millisecond),

Time Frame: 11 months 19 days

FFR peaks latency (millisecond),

Time Frame: 11 months 19 days

SP/AP ratio

Time Frame: 11 months 19 days

Secondary Outcomes

  • Association between recreational noise exposure & FFR(11 months 19 days)

Investigators

Sponsor
Michal Jacob
Sponsor Class
Other [self]

Study Sites (1)

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