Vestibular DisorderNCT03915353
Evaluation Of Vestibular Functions and Balance in Edirne Band Musicians
An observational study of Vestibular Disorder, run by Trakya University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Vestibular Disorder
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2017to 30 Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Adult, Older adult
Study population: 22 males working as a musician in Edirne Band and a control group working in Trakya University with similar sociodemographic characteristics.
Who may be able to join
- Over 18 years of age
- Had at least for 5 years of experience at the Edirne Band
- Volunteering to participate in the study
Who cannot join
- Diagnosed vestibular disease
- Cervical spine problems during the evaluation
- Musculoskeletal problems during the evaluation
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Vestibular Disorder
- Being tested
- No Intervention
- Keywords
- Noise, Balance, Quality of Life
- Medical subject headings
- Vestibular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
No Intervention
| Study group | Role | What they receive |
|---|---|---|
| Experiment | No interventions Receives: Other: No Intervention | |
| Control | No interventions Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 20 minutes after obtaining socio-demographic information, participants who met the inclusion criteria included in the test.
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
Measured: 25 minutes after obtaining socio-demographic information, participants who met the inclusion criteria included in the test.
Secondary outcomes (2)
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.
Measured: 5 minutes after obtaining socio-demographic information.
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).
Measured: 10 minutes after obtaining socio-demographic information.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start1 Mar 2017
- Primary completion15 Apr 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vestibular DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Halit SELÇUK, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03915353
- Sponsor's protocol ID
- 2017/234
- Status last verified
- Apr 2019
- First submitted
- 10 Apr 2019
- Last updated
- 16 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of Vestibular Functions and Balance in Edirne Band Musicians
- ClinicalTrials.gov ID
- NCT03915353
- Acronym / sponsor ID
- 2017/234
- Conditions
- Vestibular Disorder
- Keywords
- Noise, Balance, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 15 Apr 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 16 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experiment | – | Other: No InterventionNo interventions |
| Control | – | Other: No InterventionNo interventions |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Age groups
- Adult, Older adult
- Study population
- 22 males working as a musician in Edirne Band and a control group working in Trakya University with similar sociodemographic characteristics.
Key inclusion criteria (3 listed)
- Over 18 years of age
- Had at least for 5 years of experience at the Edirne Band
- Volunteering to participate in the study
Key exclusion criteria (3 listed)
- Diagnosed vestibular disease
- Cervical spine problems during the evaluation
- Musculoskeletal problems during the evaluation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionNo Intervention | Other | Control, Experiment |
Primary outcome
Romberg Test
Time frame: 20 minutes after obtaining socio-demographic information, participants who met the inclusion criteria included in the 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.
Unterberger's Test
Time frame: 25 minutes after obtaining socio-demographic information, participants who met the inclusion criteria included in the 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
2 secondary outcomes
Activities-Specific Balance Confidence Scale
Time frame: 5 minutes after obtaining socio-demographic information.
Dizziness Handicap Inventory
Time frame: 10 minutes after obtaining socio-demographic information.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Individual participant dataSharing planned: No
Related trials for Vestibular Disorder
RecruitingObservational study
Impact of Vestibular Function on Deaf Infants' Activities of Daily Living
Vestibular Dysfunction, Hearing Loss
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Comparison of Vestibular Stimulation and Core Stability Training on Sitting Balance in Hypotonic CP
Hypotonic Cerebral Palsy
Enrolling by invitationObservational study
Long Term Follow-up Study of AAVAnc80-antiVEGF Gene Therapy
Vestibular Schwannoma
RecruitingPhase 1/2
Anti-VEGF Gene Therapy Trial for Vestibular Schwannoma
Vestibular Schwannoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vestibular Disorder, run by Trakya University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Romberg Test (time frame: 20 minutes after obtaining socio-demographic information, participants who met the inclusion criteria included in the test.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2019.