The 'Lombard Effect' in Patients Affected by Adductor Laryngeal Dystonia: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Maximum Frequency (Hz)
研究概览
简要总结
Adductory spasmodic dysphonia (AdSD) is a rare condition characterised by irregular and uncontrolled voice interruptions, most commonly affecting women around the age of 45. The diagnosis is clinical and usually requires evaluation by several specialists. The exact cause is not known, but a disturbance of the motor system is hypothesised, probably related to various causes such as loss of cortical inhibition or problems with sensory input.
Neuroimaging studies have shown hyperactivity in various brain regions during speech production in patients with AdSD, but it is still unclear whether this hyperactivity is due to a malfunction of auditory and somatosensory feedback or an impairment of motor programming.
Recent research indicates that patients with AdSD show excessive muscle activation during phonation, probably due to abnormal processing of auditory feedback. This suggests that intervention in the auditory system may offer new treatment opportunities.
The proposed study aims to describe the acoustic, auditory-perceptual and subjective voice and speech changes in AdSD subjects during the Quick-Lombard Test (LT), a test that assesses vocal response under noisy conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Native Italian-speaking patients;
- •Normal hearing, hearing threshold < 20 dB HL for frequencies from 0.5 to 4 KHz;
- •Age >18 years and <65 years;
- •Written informed consent.
排除标准
- •Non-Italian-speaking patients.
- •Patients undergoing treatment for dystonia.
- •Previous laryngeal surgery.
- •Patient undergoing speech therapy.
- •Patient undergoing dopaminergic therapy.
- •Inability to sustain phonation of sufficient duration >3 seconds or to perform sufficient tests to assess vocal outcomes.
- •Lack of written informed consent.
结局指标
主要结局
Maximum Frequency (Hz)
时间窗: At the time of enrollement
The Maximum Frequency (Hz) is the highest frequency recorded within the voice signal
OMNI Vocal Effort Scale
时间窗: At the time of enrollement
It is a validated instrument for the assessment of vocal effort perceived by the patient with AdSD. The OMNI-VES is a visual analogue scale 0-10 with graphic representation of vocal effort. The OMNI-VES will be administered under silent conditions and after the LT
Maximum Phonation Time
时间窗: at the time of enrollement
The maximum phonatory time (TMF) will be obtained by asking the subject to sustain the vowel /a/ as long as possible in one breath. The longest of the three attempts will be calculated as TMF in seconds. The TMF will be obtained before and during LT.
Maximum Intensity (dB SPL)
时间窗: At the time of enrollement
The Maximum Intensity (dB SPL) parameter refers to the highest intensity of the recorded voice signal
Cepstral Peak Prominence-Smoothed (CPPS)
时间窗: At the time of enrollement
Cepstral Peak Prominence-Smoothed (CPPS) has been defined as a spectrum of a spectrum, whereby an inverse Fast Fourier Transform of the natural log of a frequency-domain spectrum is applied, transforming the spectrum to the time domain. The cepstral peak (CP) is a representation of the most dominant peak in the cepstrum - normally the fundamental frequency (fo) in a type I signal. After its first applications to voice was established the method of normalizing the amplitude of the overall cepstrum using a linear regression line. When applied to the cepstrum, the level difference (dB) between the cepstral peak and the regression line at the same quefrency provides the cepstral peak prominence (CPP). The CPPS values obtained from speech and vowel tasks proved reliable in predicting overall grade of dysphonia as well as breathiness.
Auditory-perceptual assessment
时间窗: At the time of enrollement
Blinded perceptual assessment, using the Global Grading Scale - Hoarseness - Straining - Asthenia - Straining (GRBAS) 0-3 (0 = normal; 1 = mild; 2 = moderate; 3 = severe) will be performed on the recorded voice samples by two speech therapists who will not be involved in the patients' care. Each voice sample will be anonymised and randomly distributed to the assessors.
Average Frequency (Hz)
时间窗: At the time of enrollement
The Average Frequency is the fundamental frequency of the voice (pitch) usually ranges from approximately 30-300 Hz, but this varies according to different speakers: typically males' pitch ranges from 50-180Hz and females from 80-250Hz, so we usually set the pitch range to a reasonable range of 50-400Hz for general usage
Degree of Voice Interruptions (%)
时间窗: At the time of enrollement
Degree of Voice Interruptions (%) is useful for the evaluation of temporary vocal interruption
Number of Voice Interruptions
时间窗: At the time of enrollement
Number of Voice Interruptions is useful for the evaluation of temporary vocal interruption
次要结局
未报告次要终点