Loss of Balance Experienced by Industrial Workers Due to... | NCT07515833

Studies
Loss of Balance Experienced by Industrial Workers Due to Hearing Problems

NCT07515833

Sponsor

Yeditepe University

Status

Not yet recruiting

Last Update Posted

Apr 13, 2026Actual

Enrollment

35Estimated

Phase

Not provided

Conditions

Balance
Hearing Problems

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2026Estimated

Primary Completion Date

Oct 1, 2026Estimated

Completion Date

Jan 1, 2027Estimated

First Submitted Date

Mar 31, 2026

First Submission Date that Met QC Criteria

Mar 31, 2026

First Posted Date

Apr 7, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 8, 2026

Last Update Posted Date

Apr 13, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study will investigate the balance performance and balance-related activities of daily living in 35 industrial workers with hearing problems exposed to occupational noise, using the Berg Balance Scale and the Vestibular Disorders Activities of Daily Living Scale. The research aims to determine whether there is a statistically significant association between hearing problems, balance performance, and daily noise exposure duration. It is hypothesized that while hearing problems related to occupational noise exposure may exist, they may not be directly associated with clinically significant balance impairment, potentially remaining at a tolerable level in daily life. Furthermore, the correlation between Berg Balance Scale and daily living activity scores will be evaluated to understand the functional impact of balance on these workers.

Detailed Description

Background:

Industrial workers are frequently exposed to high levels of occupational noise, which constitutes one of the most common causes of hearing problems and noise-induced hearing loss. In addition to auditory impairment, prolonged noise exposure may affect balance functions due to the close anatomical relationship between the auditory and vestibular systems.

Objective:

The aim of this study is to investigate balance performance and balance-related activities of daily living in industrial workers with hearing problems who are exposed to occupational noise.

Methods:

This cross-sectional study will include 35 industrial workers with hearing problems who are exposed to occupational noise. Balance performance will be assessed using the Berg Balance Scale, and balance-related activities of daily living will be evaluated using the Vestibular Disorders Activities of Daily Living Scale. Sociodemographic characteristics and duration of daily noise exposure will be recorded. Statistical analyses will be performed using non-parametric tests and correlation analysis to identify potential relationships between variables.

Expected Outcome / Conclusion:

The study intends to determine whether balance problems experienced by industrial workers with hearing problems remain at a tolerable level in daily life. It is hypothesized that hearing problems related to occupational noise exposure may not be directly associated with clinically significant balance impairment in this population.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

35Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
industrial workers		Employment in industrial or heavy industrial settings Age between 18 and 60 years Presence of hearing problems diagnosed prior to or after starting industrial work

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Berg Balance Scale	The Berg Balance Scale was used to assess static and dynamic balance performance. The scale consists of 14 items and scores range from 0 to 56, with higher scores indicating better balance performance.	Day 1
Vestibular Disorders Activities of Daily Living Scale	The Vestibular Disorders Activities of Daily Living Scale (VADL) was used to evaluate balance-related difficulties in daily life. he scale assesses functional, ambulation, and instrumental activities of daily living across 28 items. Scores range from 1 to 10, where higher scores indicate a worse outcome (greater self-perceived disability).	Day 1

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Employment in industrial or heavy industrial settings
Age between 18 and 60 years
Presence of hearing problems diagnosed prior to or after starting industrial work

Exclusion Criteria:

Employment in office-based industrial positions
Working duration of less than one year

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Participants will be employed in two different industrial sectors: the paint industry and the agricultural machinery manufacturing industry.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Şevval Ön, Physiotherapist	Contact	+905359289216		onnsevval@gmail.com

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006311	Hearing Disorders

Ancestor Terms

ID	Term
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases
D012678	Sensation Disorders
D009461	Neurologic Manifestations

Browse Leaves

Not provided

Browse Branches

Not provided