Voice Analysis in Asthmatic Patients With Machine Learning Models

NCT ID: NCT06820671

Last Updated: 2025-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

344 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-09

Study Completion Date

2025-02-20

Brief Summary

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Asthma can lead to various factors that impair voice production, including airway restriction, inflammation, and mucus production, resulting in changes in voice frequency and amplitude. Therefore, voice analysis may serve as an indicator of respiratory diseases.

A national, observational, case-control study is planned in Türkiye to analyze differences in voice between healthy subjects and asthmatic patients and to assess voice analysis techniques for determining an effective biomarker for asthma control using a machine learning model.

Detailed Description

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Asthma is a disease characterized by chronic inflammation. Based on the frequency of symptoms and the use of reliever medications, the disease can be classified as either 'controlled' or 'uncontrolled'. Currently, GINA criteria and Asthma Control Test can be used to evaluate asthma control.

The relationship between respiratory functions and speech has been previously studied, revealing that voice changes can occur in asthmatic patients due to symptom presence. Asthma can lead to various factors that impair voice production, including airway restriction, inflammation, and mucus production, resulting in changes in voice frequency and amplitude. Therefore, voice analysis may serve as an indicator of respiratory diseases. Understanding the alterations in phonation/voice due to the underlying disease is crucial.

This study seeks to analyze differences in voice between healthy subjects and asthmatic patients and to assess voice analysis techniques for determining an effective biomarker for asthma control using a machine learning model.

This is a national, observational, cross-sectional study that will be conducted in Türkiye. The study consists of two stages: in the first stage, a machine learning (ML) model will be developed using voice data collected from both healthy individuals and patients diagnosed with asthma. In the second stage, this ML model will be tested to detect voice differences among patients at different levels of asthma control.

Conditions

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Asthma

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Asthmatic Group

Diagnosed asthma patients Adults aged between 18 and 65 years of age who have been diagnosed with asthma and followed-up for at least 3 months

Recording voice samples

Intervention Type OTHER

Voice recording with

* reading the standard text
* repeating the test words
* vowel elicitation of 'a' and 'o' vowels for 5-10 seconds

Healthy Group

Healthy participants Adults aged between 18-65 years of age with good general health

Recording voice samples

Intervention Type OTHER

Voice recording with

* reading the standard text
* repeating the test words
* vowel elicitation of 'a' and 'o' vowels for 5-10 seconds

Interventions

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Recording voice samples

Voice recording with

* reading the standard text
* repeating the test words
* vowel elicitation of 'a' and 'o' vowels for 5-10 seconds

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients diagnosed with asthma according to GINA criteria and Pulmonary Function Test, and followed for at least three months
* 18-65 years of age.
* Sign an informed consent document
* Able to comply with the study protocol during the study period.


* Healthy participants between 18-65 years of age
* Good general health
* No history of chronic respiratory disorders
* No history of chronic systemic disorders
* No history of upper respiratory tract infections within five days prior voice recording.

Exclusion Criteria

* None

Healthy Group


* None
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Saglik Bilimleri Universitesi

OTHER

Sponsor Role collaborator

Yedikule Training and Research Hospital

OTHER

Sponsor Role collaborator

MED-CASE

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Health Sciences Yedikule Chest Diseases and Thoracic Surgery Training And Reseaerch Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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Med-ML001

Identifier Type: -

Identifier Source: org_study_id

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