Clinical Trials Directory

Trials / Completed

CompletedNCT06381297

Speech in Noise Discrimination Skills in Multiple Sclerosis Patients.

The Effect Of Medial Olivocochlear Efferents On Speech Discrimination In Noise In Multiple Sclerosis.

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
60 (actual)
Sponsor
Asuman Kucukoner · Academic / Other
Sex
All
Age
18 Years – 50 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTHearing testHearing and speech tests of MS group and control group in the presence and absence of noise will be evaluated. Suppression test will be performed with OAE test in the presence and absence of noise.
DIAGNOSTIC_TESTSpeech in noise discrimination testSpeech discrimination in noise (SDN) test will be performed in a quiet room in accordance with the Industrial Acoustic Company (IAC) standard using the Grason-Stadler GSI 61 Clinical Audiometer. After pure tone audiometry and speech tests, the GKAE test will be performed. The speech in noise discrimination test will be performed with a signal-to-noise (S/N) ratio of +10 dB. A word list at 50 dB SL will be presented to the tested ear using live sound, while simultaneously white noise at 40 dB SL will be presented to the test ear (Beattie et al. 1997). This will be done for both ears. The speech in noise discrimination test scores will be calculated as percentages (%) for both ears.
DIAGNOSTIC_TESTMontreal Cognitive Assessment ScaleTranslated into Turkish as the Montreal Cognitive Assessment Scale and abbreviated as MOBID, MOCA assesses attention, executive/managerial functions, memory, visual-spatial skills, language, abstract thinking and arithmetic. It is easy and practical to apply. The score that can be obtained varies between 0-30. The cut-off point for cognitive impairment is 21. Patients who perform below 21 points are considered to have cognitive impairment. Although it is not a battery used in the MS patient group, a study conducted on 39 MS patients and 20 healthy people showed that it can be used safely for screening purposes in patients with MS (Aksoy et al., 2013; Nasreddine et al., 2005; Selekler \& Cangoz, 2009).
DIAGNOSTIC_TESTSymbol Number Modalities Test (SDMT)Attention, visuospatial information processing speed and working memory are assessed. It is one of the subtests of the Short Repeatable Neuropsychological Battery developed to assess cognitive functions in MS (Smith, 1973).

Timeline

Start date
2020-10-09
Primary completion
2023-03-23
Completion
2023-04-23
First posted
2024-04-24
Last updated
2024-04-24

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT06381297. Inclusion in this directory is not an endorsement.