The 'Lombard Effect' in Patients Affected by Adductor Laryngeal Dystonia

Adductor Spasmodic Dysphonia Clinical Trial

— LoQVAdSD  

Official title:

The 'Lombard Effect' in Patients Affected by Adductor Laryngeal Dystonia: a Pilot Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06402214
• Other study ID #: ID 6117
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: May 1, 2025

Study information

• Verified date: April 2024
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: Maria Raffaella Marchese, MD, PhD
• Phone: +39-3391144556
• Email: raffaellamarchese[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 18
• Est. completion date: May 1, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Adductor Spasmodic Dysphonia
• Dysphonia
• Dystonia
• Dystonic Disorders
• Hoarseness

Intervention

Other:
• Lombard test
In this study a single-subject enrolment session will be set up, with the presence of a dedicated physician for informed consent, the performance of a tonal audiometric examination and a clinical practice phoniatric examination for all enrolled subjects, the collection of voice recordings both before and during the Lombard Test (LT) and the administration of the rating scales both before and after the LT performance. For each subject, voice recordings will be made of the vowel /a/ sustained for at least four seconds with a comfortable tone and volume and of the speech obtained from the reading aloud and volume of normal conversation of a phonetically balanced text (The Desert) lasting about 1 minute, first in a silent condition and then in the presence of noise. Specifically, for the LT, each subject will be exposed to a free-fieldwhite noise of speech(SWN) administered through headphones. The intensity of the noise will be 70 dB SPL. Voice recordings will be made in a quiet room.

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitario A. Gemelli IRCCS	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	OMNI Vocal Effort Scale	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	At the time of enrollement
Primary	Auditory-perceptual assessment	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.	At the time of enrollement
Primary	Maximum Phonation Time	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.	at the time of enrollement
Primary	Average Frequency (Hz)	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	At the time of enrollement
Primary	Maximum Frequency (Hz)	The Maximum Frequency (Hz) is the highest frequency recorded within the voice signal	At the time of enrollement
Primary	Maximum Intensity (dB SPL)	The Maximum Intensity (dB SPL) parameter refers to the highest intensity of the recorded voice signal	At the time of enrollement
Primary	Degree of Voice Interruptions (%)	Degree of Voice Interruptions (%) is useful for the evaluation of temporary vocal interruption	At the time of enrollement
Primary	Cepstral Peak Prominence-Smoothed (CPPS)	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.	At the time of enrollement
Primary	Number of Voice Interruptions	Number of Voice Interruptions is useful for the evaluation of temporary vocal interruption	At the time of enrollement