Automatic Voice Analysis for Dysphagia Screening in Neurological Patients

NCT06219200 | Recruiting

• 1 other identifier: CE2708
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Deglutition Disorders; Neurological Disorder

Outcome Measures

Primary Outcomes (1)

• A classification algorithm to screen swallowing disorders in neurological patients

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

  Baseline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population included a group of patients with Parkinson's disease, a group of post-stroke patients, a group of patients with amyotrophic lateral sclerosis, and a group of healthy individuals

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituti Clinici Scientifici Maugeri SpA: lead
• Politecnico di Milano: collaborator

Study Sites (2)

Istituti Clinici Scientifici Maugeri

Lissone, Lombardy, Italy

RECRUITING

Istituti Clinici Scientifici Maugeri

Milan, Lombardy, Italy

RECRUITING

MeSH Terms

Conditions

Deglutition Disorders; Nervous System Diseases

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Central Study Contacts

Beatrice De Maria, PhD

CONTACT

0250725; beatrice.demaria@icsmaugeri.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2024
• First Posted: January 23, 2024
• Study Start: October 11, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 20, 2025

Record last verified: 2025-02

Locations

IT (2)