Chronic Lung DiseaseWELMONCT05531539
Evaluation of Wearable Vest for Lung Monitoring
A study testing WELMO sensors vest in people with Chronic Lung Disease, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
This was the pilot study of the EU funded research and innovation project WELMO (Wearable Electronics for Effective Lung Monitoring) -Grant agreement number: 825572. The clinical trial involved patients suffering from a variety of respiratory pathological conditions and examined the ease-of-use and efficacy of the… Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Chronic Lung Disease
- What is being tested?
- WELMO sensors vest
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteGreece
- Study dates
- 10 Jan 2022to 30 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age >16 years
- Suffering from respiratory disease
- Outpatient at Pulmonology Department of G Papanikolaou Hospital
- Hospitalized at Pulmonology Department of G Papanikolaou Hospital
- Hospitalized at 1st ICU of G Papanikolaou Hospital
Who cannot join
- Age <16 years
- Skin allergies or broken skin
- Unwilling to provide informed consent
Trial locations and contacts
1 site in 1 country.
Greece1 site
1st ICU, "G.Papanikolaou" General Hospital of Thessaloniki, Greece
Thessaloniki, 57010
About this study
Official title: 2nd Clinical Trial of WELMO System With Respiratory Patients
This was the pilot study of the EU funded research and innovation project WELMO (Wearable Electronics for Effective Lung Monitoring) -Grant agreement number: 825572. The clinical trial involved patients suffering from a variety of respiratory pathological conditions and examined the ease-of-use and efficacy of the WELMO system, comprising a sensors vest for thorax auscultation and recording of Electric Impedance Tomography (EIT) signals and transmitting those on the cloud for review by physicians. The study recruited and briefly monitored 27 patients who underwent brief training and subsequent wearing of the sensors vest for 15-20 minutes, after manual auscultation, spirometry and oximetry. The collected data were transmitted wirelessly to a tablet and then securely to the cloud for review by attending physicians. The usability of the system, the quality of the obtained signals and the validity of the results were evaluated.
Read the detailed description
The study recruited and briefly monitored 27 patients at the outpatient department and the medical ward of the Pulmonology Department of "G. Papanikolaou" General Hospital of Thessaloniki, Greece, as well as the 1st Intensive Care Unit of the same Hospital. Patients were recruited during their hospitalization or at the outpatient setting and informed consent was obtained before participation. They were examined with spirometry, manual auscultation of the thorax and where necessary, with chest X-ray or CT scan. They wore the WELMO sensors vest for a period of 15-20 minutes during which they performed tidal and deep breathing, cough and spirometry maneuvers and changes of posture. At the end of the study, they were requested to fill in a questionnaire about comfort and usability of the vest.
Patients from various thoracic disease categories were included from both sexes and aged 18-90 years. The study was approved by the bioethics committee of the Hospital and personal data protection provisions were in place. The obtained signals (lung sounds and EIT signals) were examined for consistency with conventionally obtained medical data and the usability, comfort, patient acceptance and practicality of the WELMO vest was assessed.
- Conditions
- Chronic Lung Disease
- Being tested
- WELMO sensors vest
- Keywords
- respiratory disease, lung auscultation, Electric Impedance Tomography, sensors, biosignals acquisition
- Medical subject headings
- Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WELMO sensors vestDevice
Wearing of a vest equipped with lung auscultation and EIT sensors for signal acquisition and transmission
| Study group | Role | What they receive |
|---|---|---|
| Outpatient Respiratory patients | Experimental | They were examined with spirometry, manual auscultation of the thorax and where necessary, with chest X-ray or CT scan. They wore the WELMO sensors vest for a period of 15-20 minutes during which they performed tidal and deep breathing, cough and spirometry maneuvers and changes of posture. At the end of the study, they were requested to fill in a questionnaire about comfort and usability of the vest. Receives: Device: WELMO sensors vest |
| Hospitalized Respiratory patients | Experimental | They were examined with spirometry, manual auscultation of the thorax and where necessary, with chest X-ray or CT scan. They wore the WELMO sensors vest for a period of 15-20 minutes during which they performed tidal and deep breathing, cough and spirometry maneuvers and changes of posture. At the end of the study, they were requested to fill in a questionnaire about comfort and usability of the vest. Receives: Device: WELMO sensors vest |
| Critically ill Respiratory patients | Experimental | They were examined with manual auscultation of the thorax and where necessary, with chest X-ray or CT scan. They wore the WELMO sensors vest for a period of 15-20 minutes during which the vest recorded the breathing provided by the mechanical ventilator. Receives: Device: WELMO sensors vest |
What is being measured
The primary outcome is the main question the study is designed to answer.
usability of WELMO vest
Likert type Questionnaire about the usability /patient acceptance/ ease of wearing/ feeling of restriction of respiration/ aesthetic view of the specialized WELMO sensors vest.
Measured: 1 day for every patient
Secondary outcomes (2)
Validity of WELMO vest signals (sounds)
Comparison of the obtained auscultation signals with conventionally acquired biosignals
Measured: 1 day for every patient
Validity of WELMO vest signals (EIT)
Comparison of the obtained auscultation signals with conventionally acquired biosignals
Measured: 1 day for every patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2022
- Study start10 Jan 2022
- Primary completion22 Jul 2022
- Study completion30 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Lung DiseaseStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Collaborators
- George Papanicolaou Hospital
- Responsible party
- Sponsor
- Investigators
- Evangelos Kaimakamis, MD, MSc, PhD, Principal investigator, 1st ICU, G. papanikolaou Hospital, Thessaloniki, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05531539
- Sponsor's protocol ID
- WELMO-THESS
- Acronym
- WELMO
- Status last verified
- Sep 2022
- First submitted
- 22 Aug 2022
- Last updated
- 10 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rocha BM, Filos D, Mendes L, Serbes G, Ulukaya S, Kahya YP, Jakovljevic N, Turukalo TL, Vogiatzis IM, Perantoni E, Kaimakamis E, Natsiavas P, Oliveira A, Jacome C, Marques A, Maglaveras N, Pedro Paiva R, Chouvarda I, de Carvalho P. An open access database for the evaluation of respiratory sound classification algorithms. Physiol Meas. 2019 Mar 22;40(3):035001. doi: 10.1088/1361-6579/ab03ea.
PubMed 30708353Frerichs I, Vogt B, Wacker J, Paradiso R, Braun F, Rapin M, Caldani L, Chetelat O, Weiler N. Multimodal remote chest monitoring system with wearable sensors: a validation study in healthy subjects. Physiol Meas. 2020 Feb 5;41(1):015006. doi: 10.1088/1361-6579/ab668f.
PubMed 31891938Frerichs I, Lasarow L, Strodthoff C, Vogt B, Zhao Z, Weiler N. Spatial Ventilation Inhomogeneity Determined by Electrical Impedance Tomography in Patients With Chronic Obstructive Lung Disease. Front Physiol. 2021 Dec 13;12:762791. doi: 10.3389/fphys.2021.762791. eCollection 2021.
PubMed 34966289Kilintzis V, Alexandropoulos VC, Beredimas N, Maglaveras N. A Methodology for an Auto-Generated and Auto-Maintained HL7 FHIR OWL Ontology for Health Data Management. Stud Health Technol Inform. 2021 Nov 18;287:99-103. doi: 10.3233/SHTI210824.
PubMed 34795090
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 2nd Clinical Trial of WELMO System With Respiratory Patients
- ClinicalTrials.gov ID
- NCT05531539
- Acronym / sponsor ID
- WELMO / WELMO-THESS
- Conditions
- Chronic Lung Disease
- Keywords
- respiratory disease, lung auscultation, Electric Impedance Tomography, sensors, biosignals acquisition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Collaborators
- George Papanicolaou Hospital
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 22 Jul 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 8 Sep 2022 (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.
This was the pilot study of the EU funded research and innovation project WELMO (Wearable Electronics for Effective Lung Monitoring) -Grant agreement number: 825572. The clinical trial involved patients suffering from a variety of respiratory pathological conditions and examined the ease-of-use and efficacy of the WELMO system, comprising a sensors vest for thorax auscultation and recording of Electric Impedance Tomography (EIT) signals and transmitting those on the cloud for review by physicians. The study recruited and briefly monitored 27 patients who underwent brief training and subsequent wearing of the sensors vest for 15-20 minutes, after manual auscultation, spirometry and oximetry. The collected data were transmitted wirelessly to a tablet and then securely to the cloud for review by attending physicians. The usability of the system, the quality of the obtained signals and the validity of the results were evaluated.
Detailed description
The study recruited and briefly monitored 27 patients at the outpatient department and the medical ward of the Pulmonology Department of "G. Papanikolaou" General Hospital of Thessaloniki, Greece, as well as the 1st Intensive Care Unit of the same Hospital. Patients were recruited during their hospitalization or at the outpatient setting and informed consent was obtained before participation. They were examined with spirometry, manual auscultation of the thorax and where necessary, with chest X-ray or CT scan. They wore the WELMO sensors vest for a period of 15-20 minutes during which they performed tidal and deep breathing, cough and spirometry maneuvers and changes of posture. At the end of the study, they were requested to fill in a questionnaire about comfort and usability of the vest.
Patients from various thoracic disease categories were included from both sexes and aged 18-90 years. The study was approved by the bioethics committee of the Hospital and personal data protection provisions were in place. The obtained signals (lung sounds and EIT signals) were examined for consistency with conventionally obtained medical data and the usability, comfort, patient acceptance and practicality of the WELMO vest was assessed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Outpatient Respiratory patients | Experimental | Device: WELMO sensors vestThey were examined with spirometry, manual auscultation of the thorax and where necessary, with chest X-ray or CT scan. They wore the WELMO sensors vest for a period of 15-20 minutes during which they performed tidal and deep breathing, cough and spirometry maneuvers and changes of posture. At the end of the study, they were requested to fill in a questionnaire about comfort and usability of the vest. |
| Hospitalized Respiratory patients | Experimental | Device: WELMO sensors vestThey were examined with spirometry, manual auscultation of the thorax and where necessary, with chest X-ray or CT scan. They wore the WELMO sensors vest for a period of 15-20 minutes during which they performed tidal and deep breathing, cough and spirometry maneuvers and changes of posture. At the end of the study, they were requested to fill in a questionnaire about comfort and usability of the vest. |
| Critically ill Respiratory patients | Experimental | Device: WELMO sensors vestThey were examined with manual auscultation of the thorax and where necessary, with chest X-ray or CT scan. They wore the WELMO sensors vest for a period of 15-20 minutes during which the vest recorded the breathing provided by the mechanical ventilator. |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Age >16 years
- Suffering from respiratory disease
- Outpatient at Pulmonology Department of G Papanikolaou Hospital
- Hospitalized at Pulmonology Department of G Papanikolaou Hospital
- Hospitalized at 1st ICU of G Papanikolaou Hospital
Key exclusion criteria (3 listed)
- Age <16 years
- Skin allergies or broken skin
- Unwilling to provide informed consent
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 |
|---|---|---|
| WELMO sensors vestWearing of a vest equipped with lung auscultation and EIT sensors for signal acquisition and transmission | Device | Critically ill Respiratory patients, Hospitalized Respiratory patients, Outpatient Respiratory patients |
Primary outcome
usability of WELMO vest
Time frame: 1 day for every patient
Likert type Questionnaire about the usability /patient acceptance/ ease of wearing/ feeling of restriction of respiration/ aesthetic view of the specialized WELMO sensors vest.
2 secondary outcomes
Validity of WELMO vest signals (sounds)
Time frame: 1 day for every patient
Validity of WELMO vest signals (EIT)
Time frame: 1 day for every patient
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2022.
- Results publication: PubMed 30708353Rocha BM, Filos D, Mendes L, Serbes G, Ulukaya S, Kahya YP, Jakovljevic N, Turukalo TL, Vogiatzis IM, Perantoni E, Kaimakamis E, Natsiavas P, Oliveira A, Jacome C, Marques A, Maglaveras N, Pedro Paiva R, Chouvarda I, de Carvalho P. An open access database for the evaluation of respiratory sound classification algorithms. Physiol Meas. 2019 Mar 22;40(3):035001. doi: 10.1088/1361-6579/ab03ea.
- Results publication: PubMed 31891938Frerichs I, Vogt B, Wacker J, Paradiso R, Braun F, Rapin M, Caldani L, Chetelat O, Weiler N. Multimodal remote chest monitoring system with wearable sensors: a validation study in healthy subjects. Physiol Meas. 2020 Feb 5;41(1):015006. doi: 10.1088/1361-6579/ab668f.
- Results publication: PubMed 34966289Frerichs I, Lasarow L, Strodthoff C, Vogt B, Zhao Z, Weiler N. Spatial Ventilation Inhomogeneity Determined by Electrical Impedance Tomography in Patients With Chronic Obstructive Lung Disease. Front Physiol. 2021 Dec 13;12:762791. doi: 10.3389/fphys.2021.762791. eCollection 2021.
- Results publication: PubMed 34795090Kilintzis V, Alexandropoulos VC, Beredimas N, Maglaveras N. A Methodology for an Auto-Generated and Auto-Maintained HL7 FHIR OWL Ontology for Health Data Management. Stud Health Technol Inform. 2021 Nov 18;287:99-103. doi: 10.3233/SHTI210824.
- Official website of EU funded WELMO projectLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Chronic Lung Disease
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
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
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.
Evangelos Kaimakamis, MD, MSc, PhD principal investigator
1st ICU, G. papanikolaou Hospital, Thessaloniki, Greece
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WELMO sensors vest in people with Chronic Lung Disease, run by Aristotle University Of Thessaloniki at 1 site in Greece.
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 5 inclusion and 3 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: finished, as of the sponsor's last update on 10 Sep 2022. 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 Greece. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
usability of WELMO vest (time frame: 1 day for every patient). 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 NCT05531539, which also lists 4 linked publications.
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 10 Sep 2022.