Clinical trial NCT06381297: Speech in Noise Discrimination Skills in Multiple Sclerosis Patients.
Official title: The Effect Of Medial Olivocochlear Efferents On Speech Discrimination In Noise In Multiple Sclerosis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis-Relapsing-Remitting
Keywords: Multıple sclerosis,
Auditory efferent system
Contralateral supression
speech in noise discrimination
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2024-04-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Multiple sclerosis patient group and healthy control group.
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this clinical trial was to determine the effect of multiple sclerosis on speech reception and discrimination in noise and to compare the effects on the medial olivocochlear reflex, which is thought to affect speech intelligibility in noise, with a control group.

The main questions it aims to answer are:

Does MS disease affect the ability to discriminate speech in noise? Does MS affect contralateral suppression results assessing medial olivocochlear function? Is there a correlation between the ability to discriminate speech in noise and contralateral suppression skills of MS patients? Data from MS patients and healthy participants will be compared. Thirty relapsing remitting MS patients and 30 healthy participants admitted to the clinic will be evaluated.

Detailed description: The second aim was to evaluate the relationship between speech comprehension and discrimination skills in noise and cognitive function and to compare them with the control group.

Inclusion Criteria for the Study Group

1. Being diagnosed with MS (Primary Progressive, Secondary Progressive, Relapsing Remittting) - exclusion criteria for the control group
2. Being between 18-50 years old
3. Volunteering
4. Co-operation with the scales and tests to be applied
5. Normal ENT otoscopic (external and middle ear) examination findings
6. Having a normal (type A) tympanogram with a peak value of ± 50 daPa on acoustic impedancemetry examination
7. Pure voice average within normal limits (Clark, 1981).
8. Speech scores within normal limits (Jerger \& Hayes, 1977).
9. No other neurological, psychiatric, metabolic diseases other than MS
10. No history of noise exposure and ototoxic drug use Exclusion Criteria for Volunteers

1) Not diagnosed with MS (Primary Progressive, Secondary Progressive, Relapsing Remittting) - inclusion criteria for the control group 2) Being younger than 18 years old and older than 50 years old 3) Not wanting to participate in the study or giving up participation 4) Inability to cooperate with the scales and tests to be applied 5) Detection of pathology in ENT otoscopic (external and middle ear) examination findings 6) Obtaining Type B and Type C tympanograms 7) Hearing loss 8) Speech scores are not normal 9) Having any neurological, psychiatric, metabolic disease - MS diagnosis is the inclusion criterion for the study group 10) History of noise exposure and ototoxic drug use The primary endpoint of the study will be to evaluate whether there is a relationship between the MOC reflex and the thresholds for speech reception and discrimination in noise in individuals diagnosed with MS.

It will be evaluated whether cognitive function differences in individuals diagnosed with MS show differences in speech in noise and discrimination thresholds.

Eligibility criteria: Inclusion Criteria:

Clinical diagnosis of Relapsing-remitting MS The absence of other neurological, psychiatric or metabolic diseases besides MS.

Exclusion Criteria:

Exclusion criteria for this group included patients with exacerbation and/or steroid treatment in the last three months, as well as those with a history smoking, alcohol or sedative drug use, unstable vital signs, pregnancy, and serious health problems such as heart or kidney failure, major depression, severe anemia, immunodeficiency, narcolepsy, etc.

Primary outcomes:
measure: Pure tone Audiometry Test
timeFrame: six month
measure: Speech Audiometry
timeFrame: six month
measure: Speech Discrimination in Noise Test
timeFrame: Six month
measure: Otoacoustic Emission Test
timeFrame: Six month
measure: Contralateral Suppression Test
timeFrame: Six month
Secondary outcomes:
measure: Montreal Cognitive Assessment Scale
timeFrame: Six Month
measure: Symbol Digit Modalities Test
timeFrame: Six Month
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Ondokuz Mayıs University
Study officials:
affiliation: Ondokuz Mayıs University
name: ASUMAN KÜÇÜKÖNER, Dr.
role: PRINCIPAL_INVESTIGATOR
References: