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

Otoacoustics Emissions Contralateral Supression Test

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07136311
Acronym
MS
Enrollment
49
Registered
2025-08-22
Start date
2022-06-01
Completion date
2025-06-30
Last updated
2025-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hearing Loss, Multiple Sclerosis, Obesity

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.

Interventions

DIAGNOSTIC_TESTDPOAE 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.

Sponsors

Ondokuz Mayıs University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Masking description

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.

Intervention model description

Interventional (Clinical Trial)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

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)

Design outcomes

Primary

MeasureTime frameDescription
Contralateral supressionWithin 12 months of MS diagnosisComparison 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

MeasureTime frameDescription
DPOAE Amplitude LevelsWithin 12 months of MS diagnosisEvaluation 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).

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026