Ondokuz Mayıs University
Samsun, 55000, Turkey (Türkiye)
NCT Number: NCT07136311
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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Notify Me18 year–50 year
All sexes
Interventional
Not applicable
Samsun, 55000, Turkey (Türkiye)
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.
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)
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.
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).
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).
Ondokuz Mayıs University
Other
Otoacoustics Emissions Contralateral Supression Test
Acronym: MS
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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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