Speech in Noise Discrimination Skills in Multiple Sclerosis Patients.

Asuman Kucukoner

Status: Completed

Conditions: Multiple Sclerosis-Relapsing-Remitting

Treatments: Diagnostic Test: Hearing test; Diagnostic Test: Symbol Number Modalities Test (SDMT); Diagnostic Test: Montreal Cognitive Assessment Scale; Diagnostic Test: Speech in noise discrimination test

Study type: Interventional

Funder types: Other

Identifiers

NCT06381297

OndokusMU

Ondokuz Mayıs University (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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60 participants in 2 patient groups, including a placebo group

MS group

Active Comparator group

Description:

Study group (MS patients)

Treatment:

Diagnostic Test: Speech in noise discrimination test

Diagnostic Test: Symbol Number Modalities Test (SDMT)

Diagnostic Test: Montreal Cognitive Assessment Scale

Diagnostic Test: Hearing test

Control group

Placebo Comparator group

Description:

Control group ( Healty individuals)

Treatment:

Diagnostic Test: Speech in noise discrimination test

Diagnostic Test: Symbol Number Modalities Test (SDMT)

Diagnostic Test: Montreal Cognitive Assessment Scale

Diagnostic Test: Hearing test