The Effect Of Medial Olivocochlear Efferents On Speech Discrimination In Noise In Multiple Sclerosis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Contralateral Suppression Test
研究概览
简要总结
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.
详细描述
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
- Being diagnosed with MS (Primary Progressive, Secondary Progressive, Relapsing Remittting) - exclusion criteria for the control group
- Being between 18-50 years old
- Volunteering
- Co-operation with the scales and tests to be applied
- Normal ENT otoscopic (external and middle ear) examination findings
- Having a normal (type A) tympanogram with a peak value of ± 50 daPa on acoustic impedancemetry examination
- Pure voice average within normal limits (Clark, 1981).
- Speech scores within normal limits (Jerger & Hayes, 1977).
- No other neurological, psychiatric, metabolic diseases other than MS
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinical diagnosis of Relapsing-remitting MS The absence of other neurological, psychiatric or metabolic diseases besides MS.
排除标准
- •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.
结局指标
主要结局
Contralateral Suppression Test
时间窗: Six month
For TEOAE and contralateral suppression measurements, 60 dB SL white noise will be applied from the opposite ear using a TEOAE probe and emission amplitudes will be measured from the same side ear. All OAE measurements will be performed by inserting the probe once and TEOAE and contralateral suppression tests will be performed respectively. Amplitude (dB) values obtained with suppression at 1000, 1414, 2000, 2828 and 4000 Hz will be used as study parameters.
Otoacoustic Emission Test
时间窗: Six month
TEOAE measurements of all individuals in the study and control groups will be performed using the computer-based Otodynamics ILO-V6 'cochlear emission analyzer' and software version 5.61 (Otodynamics, London). Adult TEOAE probe will be used for all OAE measurements. The probe will be calibrated in a 1 cc acoustic calibration cavity. The measurement will be performed by averaging the nonlinear, 80 µsec, 260 click stimulus response at 80 ± 3 dB SPL. "Noise rejection level of 47 dB, wave reproducibility of 70% or more, and stimulus stability greater than 80% will be taken into consideration.
Pure tone Audiometry Test
时间窗: six month
Air and bone conduction hearing thresholds will be measured using a Grason-Stadler GSI 61 Clinical Audiometer in a quiet room of the Industrial Acoustic Company (IAC) Inc. standard. Airway hearing thresholds will be measured using Telephonics TDH 39 headphones and bone conduction hearing thresholds will be measured using Radioear B-71 bone vibrator. Airway hearing thresholds will be evaluated at frequencies of 0.25 -8 kHz and bone conduction hearing thresholds at 0.5-4 kHz. As pure tone average, 500-1000-2000 Hz air and bone conduction thresholds will be calculated separately for both ears. A pure tone average between 0-15 dB will be considered normal hearing.
Speech Audiometry
时间窗: six month
Speech Audiometry will be performed in a quiet room to IAC (Industrial Acoustic Company) standards using a Grason-Stadler GSI 61 Clinical Audiometer. Speech reception threshold will be determined using three syllable word lists. A 40 dB Sensation Level (SL) will be added above the speech reception threshold and the patient will be asked if he/she can hear comfortably. After determining the level at which the patient can hear most comfortably, 25-word monosyllabic isophonic word lists will be read and the speech discrimination score will be calculated as a percentage. Individuals with a speech discrimination score of 88% and above and with an agreement between speech reception threshold and pure tone averages (SSO) will be included in the study.
Speech Discrimination in Noise Test
时间窗: Six month
The 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.
次要结局
- Symbol Digit Modalities Test(Six Month)
- Montreal Cognitive Assessment Scale(Six Month)
研究者
Asuman Kucukoner
Lecturer
Ondokuz Mayıs University