NCT06705647

Brief Summary

The Study aims to identify the changes in voice caused by Chronic Obstructive Pulmonary Disease (COPD) statistically for identifying the potential digital voice biomarkers.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 28, 2024

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

November 22, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 26, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2025

Completed
Last Updated

November 26, 2024

Status Verified

November 1, 2024

Enrollment Period

4 months

First QC Date

November 22, 2024

Last Update Submit

November 25, 2024

Conditions

Keywords

Acoustic featuresStatistic analysisMel frequency cepstral coefficientsVowel quadrilateral

Outcome Measures

Primary Outcomes (1)

  • Difference in Acoustic Voice Features Between COPD and Healthy Control Participants Difference in Acoustic Voice Features Between COPD and Healthy Control Participants

    This study assesses differences in baseline acoustic features (e.g., F0, HNR, jitter, shimmer, and formant frequencies), MFCC features (1-13 and derivatives Δ, ΔΔ), and vowel quadrilateral metrics (VSA from F1 and F2 of the sustained vowel 'a') between COPD and healthy controls. Acoustic features are extracted using Parselmouth and Praat, while MFCC features are computed with Librosa. Descriptive statistics (median, mean, std) are calculated, and group differences are tested for significance using the Mann-Whitney U test. Units include median, mean, std for each feature and VSA (Hertz²). Results will include p-values for group comparisons.

    30 weeks

Study Arms (2)

COPD

24 COPD participants, 12 Female and 12 Male.

Other: Chronic Obstructive Pulmonary Disease (COPD)

HC

24 HC participants, 12 Female and 12 Male.

Other: Chronic Obstructive Pulmonary Disease (COPD)

Interventions

The base line acoustic and mel frequency ceprtum coefficients will be analysed statistically between COPD voices and healthy control groups to highlight the correlation between COPD and its effects on voice production.

Also known as: Healthy Control (HC)
COPDHC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Data collected from participants 18 years old and older with and without COPD diagnosis will be used. The participants will be balanced on a gender and age basis.

You may qualify if:

  • being 18 years old and older.

You may not qualify if:

  • being under 18 years old and older.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Blekinge Institute of Technology

Karlskrona, Blekinge County, 37179, Sweden

Location

Related Publications (1)

  • Idrisoglu A, Moraes ALD, Cheddad A, Anderberg P, Whitling S, Jakobsson A, Berglund JS. Feature Analysis of the Vowel [a:] in Individuals With Chronic Obstructive Pulmonary Disease and Healthy Controls. J Voice. 2025 Oct 29:S0892-1997(25)00429-1. doi: 10.1016/j.jvoice.2025.10.013. Online ahead of print.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2024

First Posted

November 26, 2024

Study Start

October 28, 2024

Primary Completion

February 28, 2025

Study Completion

March 30, 2025

Last Updated

November 26, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Participant data can not be shared due to the GDPR. However, the dataset created can be available upon request from the institution.

Locations