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NCT Number: NCT06219200

Automatic Voice Analysis for Dysphagia Screening in Neurological Patients

The proposed study suggests using automatic voice analysis and machine learning algorithms to develop a dysphagia screening tool for neurological patients. The research involves patients with Parkinson's disease, stroke, and amyotrophic lateral sclerosis, both with and without dysphagia, along with healthy individuals. Participants perform various vocal tasks during a single recording session. Voice signals are analysed and used as input for machine learning classification algorithms. The significance of this study is that oropharyngeal dysphagia, a condition involving swallowing difficulties in the transit of food or liquids from the mouth to the esophagus, generates malnutrition, dehydration, and pneumonia, significantly contributing to management costs and hospitalization durations. Currently, there is a lack of rapid and effective dysphagia screening methods for healthcare personnel, with only expensive invasive tests and clinical scales in use.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Istituti Clinici Scientifici Maugeri, Lissone, Lombardy, Italy

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About this study

Background:

Oropharyngeal dysphagia, defined as any alterations in swallowing abilities during the transit of food or liquids from the oral cavity to the esophagus, is an insidious complication of many neurological diseases. This condition can seriously lead to severe complications such as malnutrition, dehydration, and pneumonia, which overall has a huge impact on management costs and the number of hospitalization days. In this context, it is essential to immediately recognize the risk factors and the first signs of dysphagia to take prompt adequate actions and request further clinical and instrumental evaluations. Rapid, quantitative, and effective dysphagia screening methods are not currently available to support healthcare personnel. To date, only clinical rating scales or expensive invasive tests that require specialized personnel are adopted in clinical scenarios, whereas no objective tools are still available in extra-hospital contexts to alert patients of risk situations.

Current Gaps in Knowledge and Aim:

Since oropharyngeal dysphagia is caused by an impaired coordination control of the swallowing muscles and these muscles play also an important role in the phonation process, investigating voice alterations could be a screening option to recognize dysphagia in patients with neurological diseases. In the current literature, automatic voice analysis and the use of machine learning algorithms have given relevant findings in the discrimination between neurological diseases and healthy subjects, and there are also interesting preliminary data on dysphagia. The goal of this study is to the development a machine learning classification algorithm for dysphagia screening in neurological patients using automatic voice analysis.

Study Involvement:

The study involves patients with neurological diseases (Parkinson's disease, stroke, amyotrophic lateral Sclerosis) with or without dysphagia and healthy individuals. The participants are asked to perform some vocal tasks (sustained vocal phonation, diadochokinetic tasks, production of standardized sentences, free speech) in a single experimental session at the enrolment. Voice recordings will be automatically proceeded to derive acoustic voice features, used as input for the machine learning classification algorithm. The evaluation of the participants to characterize the studied sample is carried out with the collection of anamnestic and clinical data.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with a diagnosis of stroke, Parkinson's disease, or amyotrophic lateral sclerosis, or healthy individuals.
  • Age higher than 18 years old.

Exclusion criteria

  • Cognitive impairment that do not allow participants to understand the requested vocal tasks.
  • Ear, nose,throat diseases and other disorders able to affect voice quality.

Treatment and study plan

Primary outcomes

  1. A classification algorithm to screen swallowing disorders in neurological patients

    Time frame: Baseline

    Development of a classification algorithm for dysphagia screening in neurological patients using voice analysis

Study contacts

Contact information is provided by the study sponsor or research team.

Beatrice De Maria, PhD

CONTACT

[email protected]

0250725 ext. +39

Sponsors and collaborators

Lead sponsor

Istituti Clinici Scientifici Maugeri SpA

Other

Collaborators

  • Politecnico di Milano

Registry information

Acronym: VOICED

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 23, 2024
Registry last updated
Feb 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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