Voice Analysis in Patients With Neurologic Diseases

Sponsor
Neuromed IRCCS (Other)
Overall Status
Recruiting
CT.gov ID
NCT04846413
Collaborator
(none)
100
1
22.9
4.4

Study Details

Study Description

Brief Summary

In this observational pilot study, the investigators will record and assess voice samples from healthy participants and those participants affected by neurologic diseases to evaluate possible differences in voice features.

Condition or Disease Intervention/Treatment Phase
  • Other: Speech task

Detailed Description

In this study, the investigators will evaluate the clinical features of healthy participants and those participants with neurologic disorders by applying dedicated clinical scales. Also, the investigators will assess voice impairment by using perceptual examination tools. Then, the investigators will apply spectral analysis to assess the main frequency components of voice in healthy participants and in patients affected by neurologic disorders with a prominent voice impairment. To distinguish between healthy participants and patients affected by various neurologic diseases, the investigators will apply a voice analysis based on support vector machine (SVM) classifier that included a large number of features in addition to the main frequency components of voice.

For these purposes, the investigators will assess in detail the sensitivity, specificity, positive predictive value, and negative predictive value and accuracy of all diagnostic tests. Furthermore, the investigators will calculate the area under the receiver operating characteristic (ROC) curves to verify the optimal diagnostic threshold as reflected by the associated criterion (Ass. Crit.) and Youden Index (YI). To assess possible clinical-instrumental correlations, the investigators will also use a modified algorithm of SVM analysis to calculate a continuous numerical value (the likelihood ratio [LR]) providing a measure of voice impairment severity for each participant.

Voice recordings will be performed by asking participants to produce a specific speech task with their usual voice intensity, pitch, and quality. The speech task will consist of a sustained emission of a close mid-front unrounded vowel /e/ for at least 5 seconds. Voice recordings will be collected by using a high-definition audio-recorder placed at a distance of 5 cm from the mouth. Voice samples will be recorded in linear PCM format (.wav) at a sampling rate of 44.1 kHz, with 24-bit sample size. Voice analysis will consist of three separate processes: feature extraction, selection and classification. For feature extraction, the investigators will use the OpenSMILE (audEERING GmbH, Germany), dedicated software. Then, the investigators will select and classify voice feature by using SVM algorithm included in Weka.

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Advanced Voice Analysis With Machine Learning Algorithms in Patients With Neurologic Diseases
Actual Study Start Date :
Sep 1, 2021
Anticipated Primary Completion Date :
Jul 31, 2022
Anticipated Study Completion Date :
Jul 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Patients

Patients affected by neurologic disorders showing a prominent voice impairment.

Other: Speech task
Speech task which consists of a sustained emission of the vowel /e/.

Outcome Measures

Primary Outcome Measures

  1. Voice analysis [Voice analysis with machine learning algorithms will be implemented immediately after voice recording, during the clinical evaluation of each participant.]

    Voice features obtained by using Support Vector Machine algorithm

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Clinical diagnosis of neurologic disorders
Exclusion Criteria:
  • smoking

  • bilateral/unilateral hearing loss

  • respiratory disorders

  • conditions affecting the vocal cords, including nodules.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Antonio Suppa Pozzilli Italy 86077

Sponsors and Collaborators

  • Neuromed IRCCS

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Antonio Suppa, Principal Investigator, Neuromed IRCCS
ClinicalTrials.gov Identifier:
NCT04846413
Other Study ID Numbers:
  • DIPNEUROSCI_01
First Posted:
Apr 15, 2021
Last Update Posted:
Oct 4, 2021
Last Verified:
Sep 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Antonio Suppa, Principal Investigator, Neuromed IRCCS
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 4, 2021