Multiple SclerosisMSNCT07136311
The Effect of Obesity on Contralateral Suppression in Patients With Multiple Sclerosis
A study testing DPOAE with Contralateral Suppression in people with Multiple Sclerosis and Obesity, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Multiple Sclerosis, Obesity, Hearing Loss
- What is being tested?
- DPOAE with Contralateral Suppression
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2022to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Otoacoustics Emissions Contralateral Supression Test
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.
Read the 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.
- Conditions
- Multiple Sclerosis, Obesity, Hearing Loss
- Being tested
- DPOAE with Contralateral Suppression
- Medical subject headings
- Multiple Sclerosis, Obesity, Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DPOAE with Contralateral SuppressionDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Obese and Non-Obese MS Patients Undergoing DPOAE Suppression Test | Other | Diagnostic Test, "DPOAE with Contralateral Suppression" Receives: Diagnostic Test: DPOAE with Contralateral Suppression |
| Non-Obese MS Patients | Other | Diagnostic Test - DPOAE with Contralateral Suppression Receives: Diagnostic Test: DPOAE with Contralateral Suppression |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Within 12 months of MS diagnosis
Secondary outcomes (1)
DPOAE Amplitude Levels
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).
Measured: Within 12 months of MS diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start1 Jun 2022
- Primary completion3 Jun 2024
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Interventional (Clinical Trial)
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asuman Kucukoner, Ondokuz Mayıs University
- Investigators
- Asuman Küçüköner, PD Dr, Principal investigator, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07136311
- Sponsor's protocol ID
- Ethics number 2022/ 300
- Acronym
- MS
- Status last verified
- Aug 2025
- First submitted
- 30 Jul 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data sharing is not planned prior to the publication of the study. Access may be considered after publication, upon request and subject to ethical approval.
Publications
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.
PubMed 39787552
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Otoacoustics Emissions Contralateral Supression Test
- ClinicalTrials.gov ID
- NCT07136311
- Acronym / sponsor ID
- MS / Ethics number 2022/ 300
- Conditions
- Multiple Sclerosis, Obesity, Hearing Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 3 Jun 2024 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 22 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Interventional (Clinical Trial)
| Arm | Type | Receives |
|---|---|---|
| Obese and Non-Obese MS Patients Undergoing DPOAE Suppression Test | Other | Diagnostic Test: DPOAE with Contralateral SuppressionDiagnostic Test, "DPOAE with Contralateral Suppression" |
| Non-Obese MS Patients | Other | Diagnostic Test: DPOAE with Contralateral SuppressionDiagnostic Test - DPOAE with Contralateral Suppression |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DPOAE with Contralateral SuppressionParticipants 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. | Diagnostic test | Non-Obese MS Patients, Obese and Non-Obese MS Patients Undergoing DPOAE Suppression Test |
Primary outcome
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).
1 secondary outcome
DPOAE Amplitude Levels
Time frame: Within 12 months of MS diagnosis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Background: PubMed 39787552Kucukoner 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.
- Individual participant dataSharing planned: No. Data sharing is not planned prior to the publication of the study. Access may be considered after publication, upon request and subject to ethical approval.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asuman Küçüköner, PD Dr principal investigator
Ondokuz Mayıs University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DPOAE with Contralateral Suppression in people with Multiple Sclerosis and Obesity, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contralateral supression (time frame: Within 12 months of MS diagnosis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07136311, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.