ObesityNCT07033221
Vestibular Function in Obesity
An observational study of Obesity and Vestibular Function Disorder, run by Istanbul Aydın University at 1 site in Turkey (Türkiye).
Trial summary
Previous studies have demonstrated that obesity negatively affects the human vestibular system. However, whether improvement in vestibular function occurs following the resolution of obesity remains an area requiring further investigation. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity, Vestibular Function Disorder, Balance Assessment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Apr 2025to 1 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Participants to be included in the study will be reached from patients who have applied to our hospital due to morbid obesity and are planned to undergo bariatric surgery in our hospital. Participants who meet the inclusion criteria and sign the Informed Voluntary Consent Form will be included in the study.
Who may be able to join
- The native language must be Turkish
- The participant must be between the ages of 18-60
- The participant must be suitable for bariatric surgery (BMI ≥40 kg/m2)
- Not have any previous vestibular diagnosis
- Not have any problems such as joints, muscles, or walking
Who cannot join
- Individuals with additional disabilities, neurological problems, vestibulopathy, joint, muscle or walking disorders will not be included in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul Aydin University Faculty of Medicine
Istanbul, Küçükçekmece, 34295
Dastan Temirbekov, 5314013014 ext. +90, dasekeeee@gmail.com
About this study
Official title: Evaluation of the Effect of Bariatric Surgery on the Vestibular System in Obese Patients.
Previous studies have demonstrated that obesity negatively affects the human vestibular system. However, whether improvement in vestibular function occurs following the resolution of obesity remains an area requiring further investigation. Therefore, the investigators aimed to assess and analyze vestibular system functions in patients scheduled for bariatric surgery, both before the surgery, after the surgery, and following significant weight loss.
Participants aged between 18 and 60 years who meet the inclusion criteria will be enrolled in the study. Initially, participants will undergo medical history assessment and Body Mass Index (BMI) measurement. The enrolled participants will be evaluated using the following tests at three different time points-preoperatively, at the 1st month postoperatively, and at the 6th month postoperatively: Video Head Impulse Test (vHIT), static posturography test, Berg Balance Scale, SF-12 Quality of Life Scale, and the Activity-specific Balance Confidence (ABC) Scale.
Although obesity has been shown to be associated with impaired postural balance, studies evaluating the direct effect of BMI on postural sway are limited. The aim of our study is to assess the vestibular system in obese patients before and after bariatric surgery. Through this, the investigators hope to contribute to the literature by providing balance assessments in individuals with obesity
- Conditions
- Obesity, Vestibular Function Disorder, Balance Assessment, Balance Impairment, Sleeve Gastrectomy
- Keywords
- sleeve gastrectomy, balance in obese patients, vestibular function after sleeve gastrectomy, vestibulopathy in and obesity
- Medical subject headings
- Obesity, Vestibular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Vestibular Function as Measured by Video Head Impulse Test (vHIT)
The vHIT assesses semicircular canal function by recording eye movements in response to brief, passive head rotations.
Measured: 12 months
Change in Balance Performance Using Static Posturography
Objective measurement of postural sway and stability using a force platform system under various sensory conditions.
Measured: 12 months
Secondary outcomes (3)
Change in Functional Balance Measured by Berg Balance Scale (BBS)
The BBS is a 14-item scale evaluating balance during functional activities. Scores range from 0 to 56.
Measured: 12 months
Change in Quality of Life as Measured by the SF-12 Health Survey
The SF-12 is a self-reported questionnaire assessing physical and mental health-related quality of life.
Measured: 12 months
Change in Balance Confidence Measured by the Activity-specific Balance Confidence (ABC) Scale
Self-reported confidence in performing various daily activities without losing balance. Scores range from 0% to 100%.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start5 Apr 2025
- Primary completion1 May 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Aydın University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yusuf Emre ALTUNDAL, Istanbul Aydın University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07033221
- Sponsor's protocol ID
- 60/2025
- Status last verified
- Jun 2025
- First submitted
- 24 May 2025
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Bariatric Surgery on the Vestibular System in Obese Patients.
- ClinicalTrials.gov ID
- NCT07033221
- Acronym / sponsor ID
- 60/2025
- Conditions
- Obesity, Vestibular Function Disorder, Balance Assessment, Balance Impairment, Sleeve Gastrectomy
- Keywords
- sleeve gastrectomy, balance in obese patients, vestibular function after sleeve gastrectomy, vestibulopathy in and obesity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Istanbul Aydın UniversityUniversity, hospital or other
- Study start
- 5 Apr 2025 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 24 Jun 2025 (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.
Previous studies have demonstrated that obesity negatively affects the human vestibular system. However, whether improvement in vestibular function occurs following the resolution of obesity remains an area requiring further investigation. Therefore, the investigators aimed to assess and analyze vestibular system functions in patients scheduled for bariatric surgery, both before the surgery, after the surgery, and following significant weight loss.
Participants aged between 18 and 60 years who meet the inclusion criteria will be enrolled in the study. Initially, participants will undergo medical history assessment and Body Mass Index (BMI) measurement. The enrolled participants will be evaluated using the following tests at three different time points-preoperatively, at the 1st month postoperatively, and at the 6th month postoperatively: Video Head Impulse Test (vHIT), static posturography test, Berg Balance Scale, SF-12 Quality of Life Scale, and the Activity-specific Balance Confidence (ABC) Scale.
Although obesity has been shown to be associated with impaired postural balance, studies evaluating the direct effect of BMI on postural sway are limited. The aim of our study is to assess the vestibular system in obese patients before and after bariatric surgery. Through this, the investigators hope to contribute to the literature by providing balance assessments in individuals with obesity
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Participants to be included in the study will be reached from patients who have applied to our hospital due to morbid obesity and are planned to undergo bariatric surgery in our hospital. Participants who meet the inclusion criteria and sign the Informed Voluntary Consent Form will be included in the study.
Key inclusion criteria (5 listed)
- The native language must be Turkish
- The participant must be between the ages of 18-60
- The participant must be suitable for bariatric surgery (BMI ≥40 kg/m2)
- Not have any previous vestibular diagnosis
- Not have any problems such as joints, muscles, or walking
Key exclusion criteria (1 listed)
- Individuals with additional disabilities, neurological problems, vestibulopathy, joint, muscle or walking disorders will not be included in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Vestibular Function as Measured by Video Head Impulse Test (vHIT)
Time frame: 12 months
The vHIT assesses semicircular canal function by recording eye movements in response to brief, passive head rotations.
Change in Balance Performance Using Static Posturography
Time frame: 12 months
Objective measurement of postural sway and stability using a force platform system under various sensory conditions.
3 secondary outcomes
Change in Functional Balance Measured by Berg Balance Scale (BBS)
Time frame: 12 months
Change in Quality of Life as Measured by the SF-12 Health Survey
Time frame: 12 months
Change in Balance Confidence Measured by the Activity-specific Balance Confidence (ABC) Scale
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
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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.
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 Obesity and Vestibular Function Disorder, run by Istanbul Aydın 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 5 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 24 Jun 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dastan Temirbekov, Assistant professor (5314013014 ext. +90, dasekeeee@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Vestibular Function as Measured by Video Head Impulse Test (vHIT) (time frame: 12 months). 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 24 Jun 2025.