Chronic Obstructive Pulmonary Disease"MoniToux"NCT03177694
A Wireless Bed Sensor for Monitoring Coughs
An observational study of Chronic Obstructive Pulmonary Disease and Respiratory Disease, run by Ligue Pulmonaire Neuchâteloise.
Trial summary
Aging of the population is dramatically increasing the number of hospitalized patients, with the consequent challenges of limited medical personnel and resources in hospitals. Wireless technologies that create highly connected healthcare environments are developed to help hospitals address these issues, once these… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Respiratory Disease
- What is being tested?
- Wireless bed sensor
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2018to May 2019
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male and female subjects aged ≥ 18 years fulfilling all of the inclusion criteria are eligible for the study. The presence of any one of the exclusion criteria will lead to exclusion of the participant.
Who may be able to join
- Suffering from chronic obstructive pulmonary disease (COPD I to IV) or other respiratory diseases generating dry or productive cough and hospitalized for a minimal duration of 5 days
- Living in the Canton of Neuchâtel
- Understanding French
Who cannot join
- Suffering from cognitive disorders
- Refractory to test new technologies
About this study
Official title: A Prospective Observational Pilot Study to Evaluate the Reliability and Usability of a Wireless Bed Sensor Connected to a Medical Data Analysis Platform to Monitor Coughs in Hospitalized Patients Suffering From Respiratory Diseases
Aging of the population is dramatically increasing the number of hospitalized patients, with the consequent challenges of limited medical personnel and resources in hospitals. Wireless technologies that create highly connected healthcare environments are developed to help hospitals address these issues, once these technologies are perfectly integrated in the hospital environment with respect to IT infrastructure for big data storage. Such devices have proven remarkable efficiencies in monitoring patients with high patient safety, data accuracy and security, which are essential to provide high quality patient care, reduce health-related costs and optimize the management of high numbers of patients.
Cough is the most common condition that results in a visit to the physician. Often coughs are benign, but sometimes can be the sign of exacerbations of a chronic respiratory disease. Exacerbations are defined in the Global Initiative for Chronic Obstructive Lung Disease (GOLD) document "as an acute event characterised by a worsening of the patient's respiratory symptoms that is beyond normal day-to-day variations and leads to a change in medication". It is assumed that, if coughs were remotely monitored, hospitals might be unburdened, patients would be empowered to self-manage their health, and that prevention of serious respiratory diseases might be facilitated, thus improving health outcomes. Unfortunately, remote monitoring for cough that rely on self-reporting is impractical, as patients do not record data very reliably. On the contrary, a bed sensor under the mattress connected to a medical data analysis platform might monitor patients' micro-movements at night and alert the medical staff as soon as there is a cough exacerbation.
Read the detailed description
The clinical study is designed as a prospective observational pilot study to evaluate the reliability of a wireless bed sensor and data analysis platform to monitor coughs in hospitalized patients with respiratory diseases.
The study includes three phases:
- Calibration phase: to determine the degree of coughs' homogeneity between patients. The control source of data will be an audio-video (AV) system consisting in a microphone and a polygraph to record cough events along with an infrared webcam to register patient's movements. At the end of the calibration period, the data generated by the device will be analysed to determine if the coughs are homogeneous or heterogeneous, according to patient follow-up and AV outcomes. The degree of homogeneity will allow establishing the correct number of patients to be followed in the interventional phase (estimated 20 patients) and to set a threshold to define when there is an exacerbation.
- Observational phase: to collect data in about 20 patients from both sources, namely the bed sensor and the AV system in the patient's hospital room. Data will be collected in parallel by the two systems during two consecutive nights for each patient.
3 Data analysis phase: to correlate bed sensor's signals with the AV recorded data. AV data as well computing will enable to determine the sensitivity and the selectivity of the device-generated signals.
- Being tested
- Wireless bed sensor
- Keywords
- cough, exacerbation, connected device
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Respiration Disorders, Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wireless bed sensorDevice
Remote data collection
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of the clinical performance and accuracy of the bed sensor and of the analysis platform to detect coughs
Comparison of the % of coughs detected by the connected device and the % of coughs detected by the AV system coupled to the polygraph recordings. Comparison of control and experimental groups will be performed using t-test for continuous variable. Difference with probability values > 0.05 will be considered insignificant.
Measured: 2 nights
Secondary outcomes (2)
Patients' acceptance on the connected device
Determination of the level of acceptance of the device by patients by means of a patient questionnaire to provide feedback. Usability for patients will be assessed by the % rate of acceptance for the patients.
Measured: 2 nights
Medical staff's satisfaction on both the device and the medical analysis platform (usability, data usage)
Assessment of the satisfaction of the medical staff regarding the usability of the device and of the device-generated data by means of a health professional questionnaire to provide feedback. Usability for healthcare professionals will be assessed by the % rate of satisfaction for the healthcare professionals.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2017
- Study start1 Oct 2018 (estimated)
- Primary completion31 Mar 2019 (estimated)
- Study completionMay 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ligue Pulmonaire Neuchâteloise
- Sponsor type
- University, hospital or other
- Collaborators
- Hopital Neuchatelois, Domo-Safety S.A., Vivactis (Suisse) S.A.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03177694
- Sponsor's protocol ID
- LPNE_01
- Acronym
- "MoniToux"
- Status last verified
- Aug 2018
- First submitted
- 30 May 2017
- Last updated
- 15 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Pilot Study to Evaluate the Reliability and Usability of a Wireless Bed Sensor Connected to a Medical Data Analysis Platform to Monitor Coughs in Hospitalized Patients Suffering From Respiratory Diseases
- ClinicalTrials.gov ID
- NCT03177694
- Acronym / sponsor ID
- "MoniToux" / LPNE_01
- Keywords
- cough, exacerbation, connected device
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ligue Pulmonaire NeuchâteloiseUniversity, hospital or other
- Collaborators
- Hopital Neuchatelois, Domo-Safety S.A., Vivactis (Suisse) S.A.
- Study start
- 1 Oct 2018 (estimated)
- Primary completion
- 31 Mar 2019 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 6 Jun 2017 (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.
Aging of the population is dramatically increasing the number of hospitalized patients, with the consequent challenges of limited medical personnel and resources in hospitals. Wireless technologies that create highly connected healthcare environments are developed to help hospitals address these issues, once these technologies are perfectly integrated in the hospital environment with respect to IT infrastructure for big data storage. Such devices have proven remarkable efficiencies in monitoring patients with high patient safety, data accuracy and security, which are essential to provide high quality patient care, reduce health-related costs and optimize the management of high numbers of patients.
Cough is the most common condition that results in a visit to the physician. Often coughs are benign, but sometimes can be the sign of exacerbations of a chronic respiratory disease. Exacerbations are defined in the Global Initiative for Chronic Obstructive Lung Disease (GOLD) document "as an acute event characterised by a worsening of the patient's respiratory symptoms that is beyond normal day-to-day variations and leads to a change in medication". It is assumed that, if coughs were remotely monitored, hospitals might be unburdened, patients would be empowered to self-manage their health, and that prevention of serious respiratory diseases might be facilitated, thus improving health outcomes. Unfortunately, remote monitoring for cough that rely on self-reporting is impractical, as patients do not record data very reliably. On the contrary, a bed sensor under the mattress connected to a medical data analysis platform might monitor patients' micro-movements at night and alert the medical staff as soon as there is a cough exacerbation.
Detailed description
The clinical study is designed as a prospective observational pilot study to evaluate the reliability of a wireless bed sensor and data analysis platform to monitor coughs in hospitalized patients with respiratory diseases.
The study includes three phases:
- Calibration phase: to determine the degree of coughs' homogeneity between patients. The control source of data will be an audio-video (AV) system consisting in a microphone and a polygraph to record cough events along with an infrared webcam to register patient's movements. At the end of the calibration period, the data generated by the device will be analysed to determine if the coughs are homogeneous or heterogeneous, according to patient follow-up and AV outcomes. The degree of homogeneity will allow establishing the correct number of patients to be followed in the interventional phase (estimated 20 patients) and to set a threshold to define when there is an exacerbation.
- Observational phase: to collect data in about 20 patients from both sources, namely the bed sensor and the AV system in the patient's hospital room. Data will be collected in parallel by the two systems during two consecutive nights for each patient.
3 Data analysis phase: to correlate bed sensor's signals with the AV recorded data. AV data as well computing will enable to determine the sensitivity and the selectivity of the device-generated signals.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female subjects aged ≥ 18 years fulfilling all of the inclusion criteria are eligible for the study. The presence of any one of the exclusion criteria will lead to exclusion of the participant.
Key inclusion criteria (3 listed)
- Suffering from chronic obstructive pulmonary disease (COPD I to IV) or other respiratory diseases generating dry or productive cough and hospitalized for a minimal duration of 5 days
- Living in the Canton of Neuchâtel
- Understanding French
Key exclusion criteria (2 listed)
- Suffering from cognitive disorders
- Refractory to test new technologies
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 |
|---|---|---|
| Wireless bed sensorRemote data collection | Device | – |
Primary outcome
Measurement of the clinical performance and accuracy of the bed sensor and of the analysis platform to detect coughs
Time frame: 2 nights
Comparison of the % of coughs detected by the connected device and the % of coughs detected by the AV system coupled to the polygraph recordings. Comparison of control and experimental groups will be performed using t-test for continuous variable. Difference with probability values > 0.05 will be considered insignificant.
2 secondary outcomes
Patients' acceptance on the connected device
Time frame: 2 nights
Medical staff's satisfaction on both the device and the medical analysis platform (usability, data usage)
Time frame: 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2018.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease and Respiratory Disease, run by Ligue Pulmonaire Neuchâteloise.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 15 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Measurement of the clinical performance and accuracy of the bed sensor and of the analysis platform to detect coughs (time frame: 2 nights). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Aug 2018.