Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03915353
Other study ID # 2017/234
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2017
Est. completion date June 30, 2018

Study information

Verified date April 2019
Source Trakya University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

It has been stated that intense noise may affect the peripheral vestibular system and consequently cause problems in balance mechanisms. The aim of this study was to investigate the effects of exposure to chronic noise on vestibular functions and balance in Edirne Band musicians.

Twenty-two individuals working in the Edirne Band for at least 5 years and over 18 years of age and a control group of 22 individuals working at Trakya University and with similar sociodemographic characteristics to the experimental group were included. The socio-demographic questionnaire was used to inquire about the demographic characteristics of individuals and alcohol-cigarette use, the Activity-Specific Balance Confidence Scale to assess how they felt about the balance, and the Dizziness Handicap Inventory to determine the quality of life-related to dizziness. A 3D ultrasonic system was used to assess the static and dynamic balance of the individuals.


Description:

Chronic exposure to intense noise causes temporary or permanent hearing loss. The effects of exposure to intense noise on the auditory system are well explained, but the number of studies that observes the effects of noise on the vestibular system is limited. It has been stated that intense noise may affect the peripheral vestibular system and consequently cause problems in balance mechanisms. The aim of this study was to investigate the effects of exposure to chronic noise on vestibular functions and balance in Edirne Band musicians.

Twenty-two individuals working in the Edirne Band for at least 5 years and over 18 years of age who did not have a diagnosed vestibular disorder, no cervical vertebrae problem, no musculoskeletal system problems during the evaluation and a control group of 22 individuals working at Trakya University and with similar sociodemographic characteristics to the experimental group were included in the study. The socio-demographic questionnaire was used to inquire about the demographic characteristics of individuals and alcohol-cigarette use, the Activity-Specific Balance Confidence Scale to assess how they felt about the balance, and the Dizziness Handicap Inventory to determine the quality of life-related to dizziness. A 3D ultrasonic system was used to assess the static and dynamic balance of the individuals.


Recruitment information / eligibility

Status Completed
Enrollment 44
Est. completion date June 30, 2018
Est. primary completion date April 15, 2018
Accepts healthy volunteers
Gender Male
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Over 18 years of age

- Had at least for 5 years of experience at the Edirne Band

- Volunteering to participate in the study

Exclusion Criteria:

- Diagnosed vestibular disease

- Cervical spine problems during the evaluation

- Musculoskeletal problems during the evaluation

Study Design


Related Conditions & MeSH terms


Intervention

Other:
No Intervention
No Intervention

Locations

Country Name City State
Turkey Trakya University Edirne

Sponsors (1)

Lead Sponsor Collaborator
Trakya University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Romberg Test Romberg test was assessed in the Zebris system. All measurements were performed in a quiet environment. For the Romberg test, the patient was asked to stay still for 60 seconds with his eyes closed, his feet contiguous, and his shoulders at 90 degrees flexion. 20 minutes after obtaining socio-demographic information, participants who met the inclusion criteria included in the test.
Primary Unterberger's Test Unterberger's test was assessed in the Zebris system. All measurements were performed in a quiet environment. For the Unterberger's test, subjects closed their eyes and began stepping in place for 60 seconds with shoulder at 90 degrees flexion, arms extended forward 25 minutes after obtaining socio-demographic information, participants who met the inclusion criteria included in the test.
Secondary Activities-Specific Balance Confidence Scale ABC developed by Myers and Powel is a questionnaire based on evaluations of how confidently they can do 16 activities within and outside the house. Each activity scored between 0 (insecure) and 100 (completely confident). The total score (0-1600) is divided into 16 and the individual's ABC score is obtained. It has been shown to be reliable in patients with vestibular dysfunction. Higher values in ABC Scale represent a better outcome. 5 minutes after obtaining socio-demographic information.
Secondary Dizziness Handicap Inventory DHI is a questionnaire that evaluates the quality of life and the disability caused by complaints related to dizziness and imbalance. DHI, developed by Jacobson and Newman, is a 25-item scale that identifies sensory and functional outcomes in patients with vestibular system problems, as well as factors affecting dizziness and balance disorder. Three subscales are aimed to determine the physical, sensory and functional effects of vestibular system diseases. The subscale scores which are considered as the limit for the determination of disability are 28 points for physical disability and 36 points for functional and sensory disability. Higher scores indicate that the person has more disability due to dizziness. According to the total score taken from the scale, people have divided into 3 groups; 0-30 points (mild disability), 31-60 points (moderate disability), 61-100 points (severe disability). 10 minutes after obtaining socio-demographic information.
See also
  Status Clinical Trial Phase
Enrolling by invitation NCT04196933 - Analysis of Vestibular Compensation Following Clinical Intervention for Vestibular Schwannoma N/A
Completed NCT04894929 - Comprehensive Geriatric Assessment in the Monitoring of Functional Improvement N/A
Recruiting NCT04353115 - A Serious Game to Rehabilitate Gaze Stability in Children With Vestibular Deficit
Recruiting NCT04053829 - Feasibility and Acceptability of HOLOBalance Compared to Standard Care in Older Adults at Risk for Falls N/A
Completed NCT03163901 - The Effect of OMT on Functional Outcomes and Anti-inflammatory Biomarkers in Mild to Moderate Traumatic Brain Injury N/A
Active, not recruiting NCT04479761 - Sensory Integration of Auditory and Visual Cues in Diverse Contexts N/A
Recruiting NCT03624283 - Interventions for Residual Dizziness After Successful Repositioning Maneuvers in Patients With BPPV N/A
Recruiting NCT03690817 - Hearing Loss, Vestibular Loss and Cognitive Performance
Completed NCT03555370 - Vestibular Treatment in Adolescents Following Sport Related Concussion N/A
Not yet recruiting NCT05322538 - Menier's Disease - Bone Density Study N/A
Completed NCT05795530 - Vestibular Function in Cochlear Implants
Completed NCT03330262 - Head-Mounted Vibrotactile Prosthesis for Patients With Chronic Postural Instability N/A
Not yet recruiting NCT06177132 - Vestibular Infant Screening - Rehabilitation N/A
Completed NCT03952936 - Vestibular Rehabilitation for Chronic Central Vestibular Deficits: A Case Study N/A
Recruiting NCT05436067 - Individualized Vestibular Rehabilitation for Elderly With Self-Management and Gaming Elements N/A
Completed NCT03951584 - Prognosis of Vestibular Dysfunction in Patients With Idiopathic Sudden Sensorineural Hearing Loss
Recruiting NCT06407726 - Comparative Effects of Virtual Reality and Vestibular Exercises on Balance Gait in Older Adults N/A
Active, not recruiting NCT05793216 - VestibulOTherapy: Vestibular Impact on Learning N/A
Recruiting NCT05741515 - Vestibular Balance Therapy Intervention for Children N/A
Recruiting NCT04851184 - Dose of Vestibular Rehabilitation for Vestibular Hypofunction N/A