Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06381297
Status:
COMPLETED
Last Update Posted:
2024-04-24
First Post:
2024-04-01
Brief Title:
Speech in Noise Discrimination Skills in Multiple Sclerosis Patients
Sponsor:
Asuman Kucukoner
Organization:
Ondokuz Mayıs University
Study Overview
Official Title:
The Effect Of Medial Olivocochlear Efferents On Speech Discrimination In Noise In Multiple Sclerosis
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Ondokuz Mayıs University | REGISTRY | Clinical research ethics committee | None |