NCT07033221

Brief 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. 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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
1mo left

Started Apr 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Apr 2025Jun 2026

Study Start

First participant enrolled

April 5, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 24, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

June 24, 2025

Status Verified

June 1, 2025

Enrollment Period

1.1 years

First QC Date

May 24, 2025

Last Update Submit

June 13, 2025

Conditions

Keywords

sleeve gastrectomybalance in obese patientsvestibular function after sleeve gastrectomyvestibulopathy in and obesity

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    12 months

Secondary Outcomes (3)

  • Change in Functional Balance Measured by Berg Balance Scale (BBS)

    12 months

  • Change in Quality of Life as Measured by the SF-12 Health Survey

    12 months

  • Change in Balance Confidence Measured by the Activity-specific Balance Confidence (ABC) Scale

    12 months

Other Outcomes (1)

  • Obesity Status: Height, Weight, and Body Mass Index (BMI)

    12 months

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • Individuals with additional disabilities, neurological problems, vestibulopathy, joint, muscle or walking disorders will not be included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Aydin University Faculty of Medicine

Istanbul, Küçükçekmece, 34295, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

ObesityVestibular Diseases

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsLabyrinth DiseasesEar DiseasesOtorhinolaryngologic Diseases

Central Study Contacts

Dastan Temirbekov, Assistant professor

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 24, 2025

First Posted

June 24, 2025

Study Start

April 5, 2025

Primary Completion

May 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

June 24, 2025

Record last verified: 2025-06

Locations