Chronic Obstructive Pulmonary DiseaseNCT06705647
Analyzing Acoustic Properties of the Vowel "a" Collected Via Mobile Phone From Individuals Diagnosed With Chronic Obstructive Pulmonary Disease and Health Control Groups
An observational study of Chronic Obstructive Pulmonary Disease, run by Blekinge Institute of Technology at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Chronic Obstructive Pulmonary Disease (COPD)
- How many people
- 48 participants
- Where
- 1 siteSweden
- Study dates
- 28 Oct 2024to 30 Mar 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- being 18 years old and older.
Who cannot join
- being under 18 years old and older.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Blekinge Institute of Technology
Karlskrona, Blekinge County, 37179
About this study
The Study aims to identify the changes in voice caused by Chronic Obstructive Pulmonary Disease (COPD) statistically for identifying the potential digital voice biomarkers.
Read the detailed description
1058 voice recordings collected via mobile phones over time in form of the Swedish utterance of vowel "a" will be analysed using vowel quadrilateral space and the Mann-Whitney U test.
The significance threshold p-value will be set to 0.05, and vocal features consisting of 101 base line acoustic features and MFCC features will be analysed between the COPD and HC groups. The most significant features that remain under the significance threshold will be reported.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Chronic Obstructive Pulmonary Disease (COPD)
- Keywords
- Acoustic features, Statistic analysis, Mel frequency cepstral coefficients, Vowel quadrilateral
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chronic Obstructive Pulmonary Disease (COPD)Other
Also called Healthy Control (HC)
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.
| Study group | Role | What they receive |
|---|---|---|
| COPD | 24 COPD participants, 12 Female and 12 Male. Receives: Other: Chronic Obstructive Pulmonary Disease (COPD) | |
| HC | 24 HC participants, 12 Female and 12 Male. Receives: Other: Chronic Obstructive Pulmonary Disease (COPD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start28 Oct 2024
- Primary completion28 Feb 2025 (estimated)
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Blekinge Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Excellence Center at Linköping - Lund in Information Technology (ELLIIT)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06705647
- Sponsor's protocol ID
- BTH-6.1.1-0198-2024
- Status last verified
- Nov 2024
- First submitted
- 22 Nov 2024
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participant data can not be shared due to the GDPR. However, the dataset created can be available upon request from the institution.
Publications
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.
PubMed 41168019
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analyzing Acoustic Properties of the Vowel "a" Collected Via Mobile Phone From Individuals Diagnosed With Chronic Obstructive Pulmonary Disease and Health Control Groups
- ClinicalTrials.gov ID
- NCT06705647
- Acronym / sponsor ID
- BTH-6.1.1-0198-2024
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Acoustic features, Statistic analysis, Mel frequency cepstral coefficients, Vowel quadrilateral
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Blekinge Institute of TechnologyUniversity, hospital or other
- Collaborators
- Excellence Center at Linköping - Lund in Information Technology (ELLIIT)
- Study start
- 28 Oct 2024 (actual)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 26 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Study aims to identify the changes in voice caused by Chronic Obstructive Pulmonary Disease (COPD) statistically for identifying the potential digital voice biomarkers.
Detailed description
1058 voice recordings collected via mobile phones over time in form of the Swedish utterance of vowel "a" will be analysed using vowel quadrilateral space and the Mann-Whitney U test.
The significance threshold p-value will be set to 0.05, and vocal features consisting of 101 base line acoustic features and MFCC features will be analysed between the COPD and HC groups. The most significant features that remain under the significance threshold will be reported.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPD | – | Other: Chronic Obstructive Pulmonary Disease (COPD)24 COPD participants, 12 Female and 12 Male. |
| HC | – | Other: Chronic Obstructive Pulmonary Disease (COPD)24 HC participants, 12 Female and 12 Male. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- being 18 years old and older.
Key exclusion criteria (1 listed)
- being under 18 years old and older.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chronic Obstructive Pulmonary Disease (COPD)Also: Healthy Control (HC)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. | Other | COPD, HC |
Primary outcome
Difference in Acoustic Voice Features Between COPD and Healthy Control Participants Difference in Acoustic Voice Features Between COPD and Healthy Control Participants
Time frame: 30 weeks
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
- Derived from this study: PubMed 41168019Idrisoglu 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.
- Individual participant dataSharing planned: No. Participant data can not be shared due to the GDPR. However, the dataset created can be available upon request from the institution.
Related trials for Chronic Obstructive Pulmonary Disease
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by Blekinge Institute of Technology at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Acoustic Voice Features Between COPD and Healthy Control Participants Difference in Acoustic Voice Features Between COPD and Healthy Control Participants (time frame: 30 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06705647, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2024.