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

NCT07136311 | Completed DMC

• 1 other identifier: Ethics number 2022/ 300
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Obesity; Hearing Loss

Outcome Measures

Primary Outcomes (1)

• Contralateral supression

  Comparison of contralateral suppression values of distortion product otoacoustic emissions (DPOAEs) between obese and non-obese patients with Multiple Sclerosis (MS) at multiple frequencies (1 kHz, 1.4 kHz, 2 kHz, 2.8 kHz, 4 kHz, 5.6 kHz, and 8 kHz).

  Within 12 months of MS diagnosis

Secondary Outcomes (1)

• DPOAE Amplitude Levels

  Within 12 months of MS diagnosis

Study Arms (2)

Obese and Non-Obese MS Patients Undergoing DPOAE Suppression Test

OTHER

Diagnostic Test, "DPOAE with Contralateral Suppression"

Diagnostic Test: DPOAE with Contralateral Suppression

Non-Obese MS Patients

OTHER

Diagnostic Test - DPOAE with Contralateral Suppression

Diagnostic Test: DPOAE with Contralateral Suppression

Interventions

DPOAE with Contralateral Suppression 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; Obese and Non-Obese MS Patients Undergoing DPOAE Suppression Test

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Ondokuz Mayıs University

Samsun, 55000, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 39787552 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis; Obesity; Hearing Loss

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations

Study Officials

• Asuman Küçüköner, PD Dr

  Ondokuz Mayıs University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: This is an observational study with no intervention; therefore, no masking was applied. All participants and investigators were aware of the group assignments (obese vs. non-obese), and no parties beyond those listed were masked.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Interventional (Clinical Trial)

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: August 22, 2025
• Study Start: June 1, 2022
• Primary Completion: June 3, 2024
• Study Completion: June 30, 2025
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)