The Effect of Obesity on Contralateral Suppression in Patients With Multiple Sclerosis

NCT ID: NCT07136311

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2025-06-30

Brief Summary

This study investigates how obesity may affect the auditory system in individuals with Multiple Sclerosis (MS). Specifically, it examines the brain's ability to process and suppress sounds (contralateral suppression).

The test is painless and brief. It provides information about the condition of the auditory nerve pathways. The goal is to better understand how obesity may influence this system and to improve follow-up and support for individuals with MS.

Detailed Description

This study investigates the potential impact of obesity on auditory efferent system function in individuals diagnosed with Multiple Sclerosis (MS). Specifically, it focuses on assessing contralateral suppression of Distortion Product Otoacoustic Emissions (DPOAEs), a non-invasive, objective method for evaluating the integrity of the cochlear outer hair cells and the medial olivocochlear (MOC) efferent system.

Participants will undergo a brief and painless auditory test, during which DPOAEs are recorded both in quiet and with contralateral acoustic stimulation. This approach allows for the assessment of the brainstem's ability to suppress cochlear responses, which reflects central auditory processing capabilities.

By comparing suppression patterns across participants with different body mass index (BMI) classifications, the study aims to identify whether obesity contributes to functional changes in the auditory efferent system among MS patients.

The outcomes of this research may enhance the understanding of how metabolic factors such as obesity interact with neurological conditions like MS, potentially guiding more personalized clinical monitoring and interventions.

Conditions

Multiple Sclerosis; Obesity; Hearing Loss

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Obese and Non-Obese MS Patients Undergoing DPOAE Suppression Test

Diagnostic Test, "DPOAE with Contralateral Suppression"

Group Type: OTHER

DPOAE with Contralateral Suppression

Intervention Type: DIAGNOSTIC_TEST

Participants will undergo distortion evoked otoacoustic emissions (DPOAE) testing with contralateral broadband noise stimulation. The test is performed to evaluate auditory efferent system function, specifically the presence and degree of contralateral suppression. No medication or treatment is administered as part of the study. The procedure is non-invasive and commonly used in auditory diagnostics.

Non-Obese MS Patients

Diagnostic Test - DPOAE with Contralateral Suppression

Group Type: OTHER

DPOAE with Contralateral Suppression

Intervention Type: DIAGNOSTIC_TEST

Participants will undergo distortion evoked otoacoustic emissions (DPOAE) testing with contralateral broadband noise stimulation. The test is performed to evaluate auditory efferent system function, specifically the presence and degree of contralateral suppression. No medication or treatment is administered as part of the study. The procedure is non-invasive and commonly used in auditory diagnostics.

Interventions

DPOAE with Contralateral Suppression

Participants will undergo distortion evoked otoacoustic emissions (DPOAE) testing with contralateral broadband noise stimulation. The test is performed to evaluate auditory efferent system function, specifically the presence and degree of contralateral suppression. No medication or treatment is administered as part of the study. The procedure is non-invasive and commonly used in auditory diagnostics.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

Ability to cooperate with the applied scales and auditory tests

Normal findings in otoscopic examination (ear, nose, and throat evaluation)

Absence of any neurological, psychiatric, or metabolic disease other than Multiple Sclerosis (MS)

No history of significant noise exposure

For female participants: not pregnant and not in the menstrual period

Exclusion Criteria

Presence of active middle ear pathology (e.g., otitis media, tympanic membrane perforation)

Abnormal tympanometric findings

Hearing loss exceeding 20 dB HL at any frequency between 500-4000 Hz

Neurological or psychiatric disorders other than MS

History of ear surgery or otologic trauma

Use of medications known to affect auditory function (e.g., ototoxic drugs)

Inability to cooperate with audiological testing

Pregnancy

Diagnosis of metabolic or endocrine disorders (e.g., uncontrolled diabetes, thyroid dysfunction)

Body Mass Index (BMI) below 18.5 (underweight) or above 40 (morbid obesity)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ondokuz Mayıs University

OTHER

Sponsor Role: lead

Responsible Party

Asuman Kucukoner

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Asuman Küçüköner, PD Dr

Role: PRINCIPAL_INVESTIGATOR

Ondokuz Mayıs University

Locations

Ondokuz Mayıs University

Samsun, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Kucukoner A, Kucukoner O, Ozgur A, Terzi M. Effect of Medial Olivocochlear Efferents on Speech Discrimination in Noise in Multiple Sclerosis. Noise Health. 2024 Oct-Dec 01;26(123):507-513. doi: 10.4103/nah.nah_71_23. Epub 2024 Dec 30.

Reference Type: BACKGROUND

PMID: 39787552 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Ethics number 2022/ 300

Identifier Type: -

Identifier Source: org_study_id