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Completed

NCT Number: NCT07136311

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Eligibility Criteria Minimum Age: 18 Years Maximum Age: 50 Years Sex: All Gender Based: No Accepts Healthy Volunteers: No

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)

Treatment and study plan

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.

Primary outcomes

  1. Contralateral supression

    Time frame: Within 12 months of MS diagnosis

    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).

Secondary outcomes

  1. DPOAE Amplitude Levels

    Time frame: Within 12 months of MS diagnosis

    Evaluation and comparison of baseline DPOAE amplitudes (without contralateral stimulation) between obese and non-obese MS patients at all test frequencies (1 kHz, 1.4 kHz, 2 kHz, 2.8 kHz, 4 kHz, 5.6 kHz, and 8 kHz).

Sponsors and collaborators

Lead sponsor

Ondokuz Mayıs University

Other

Registry information

Official study title

Otoacoustics Emissions Contralateral Supression Test

Acronym: MS

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Aug 22, 2025
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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