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

O

Ondokuz Mayıs University

Status

Completed

Conditions

Multiple Sclerosis
Hearing Loss
Obesity

Treatments

Diagnostic Test: DPOAE with Contralateral Suppression

Study type

Interventional

Funder types

Other

Identifiers

NCT07136311
Ethics number 2022/ 300

Details and patient eligibility

About

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.

Full 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.

Enrollment

49 patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

49 participants in 2 patient groups

Obese and Non-Obese MS Patients Undergoing DPOAE Suppression Test
Other group
Description:
Diagnostic Test, "DPOAE with Contralateral Suppression"
Treatment:
Diagnostic Test: DPOAE with Contralateral Suppression
Non-Obese MS Patients
Other group
Description:
Diagnostic Test - DPOAE with Contralateral Suppression
Treatment:
Diagnostic Test: DPOAE with Contralateral Suppression

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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