Speech in Noise Discrimination Skills in Multiple Sclerosis Patients.

NCT ID: NCT06381297

Last Updated: 2024-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-09
• Study Completion Date: 2023-04-23

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.

Conditions

Multiple Sclerosis-Relapsing-Remitting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

MS group

Study group (MS patients)

Group Type: ACTIVE_COMPARATOR

Hearing test

Intervention Type: DIAGNOSTIC_TEST

Hearing 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.

Speech in noise discrimination test

Intervention Type: DIAGNOSTIC_TEST

Speech 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.

Montreal Cognitive Assessment Scale

Intervention Type: DIAGNOSTIC_TEST

Translated 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).

Symbol Number Modalities Test (SDMT)

Intervention Type: DIAGNOSTIC_TEST

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).

Control group

Control group ( Healty individuals)

Group Type: PLACEBO_COMPARATOR

Hearing test

Intervention Type: DIAGNOSTIC_TEST

Hearing 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.

Speech in noise discrimination test

Intervention Type: DIAGNOSTIC_TEST

Speech 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.

Montreal Cognitive Assessment Scale

Intervention Type: DIAGNOSTIC_TEST

Translated 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).

Symbol Number Modalities Test (SDMT)

Intervention Type: DIAGNOSTIC_TEST

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).

Interventions

Hearing test

Hearing 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.

Intervention Type: DIAGNOSTIC_TEST

Speech in noise discrimination test

Speech 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.

Intervention Type: DIAGNOSTIC_TEST

Montreal Cognitive Assessment Scale

Translated 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).

Intervention Type: DIAGNOSTIC_TEST

Symbol 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).

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Contralateral supression test

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Asuman Kucukoner

OTHER

Sponsor Role: lead

Responsible Party

Asuman Kucukoner

Lecturer

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

ASUMAN KÜÇÜKÖNER, Dr.

Role: PRINCIPAL_INVESTIGATOR

Ondokuz Mayıs University

Locations

Ondokuz Mayıs University

Samsun, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Ondokuz Mayıs University

Identifier Type: REGISTRY

Identifier Source: secondary_id

OndokusMU

Identifier Type: -

Identifier Source: org_study_id