Monitoring Coughs for the Early Detection of Worsening COPD
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorClinica Universidad de Navarra, Universidad de Navarra
About this trial
This study is for adults with COPD. Flare-ups of COPD, also known as exacerbations, can be serious and lead to hospital stays. The purpose of this research is to see if continuously and automatically monitoring a person's coughs can help predict these flare-ups early, before they become severe. Participants will use the Hyfe cough monitoring system, which includes a watch-like device worn on the wrist and a smartphone application. The system privately counts the number of coughs without recording any audio. Participants will also answer a short, weekly questionnaire about their COPD symptoms. This is an observational study, which means it will not change the regular medical care a participant receives. The participants and their care providers will not see the cough counts. The doctor will continue to manage their COPD as usual.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Must be 18 years of age or older.
Must have an existing diagnosis of COPD.
For the inpatient cohort, participants must be currently assessed as having a moderate/severe exacerbation.
For the outpatient cohort, participants must have had at least one exacerbation of any severity in the last 12 months.
Disqualifiers
Individuals who are unable to provide informed consent.
Individuals who are unable to adhere to study procedures.
For the inpatient cohort, individuals requiring invasive or non-invasive ventilation.
Individuals who live with a person who has a chronic cough.
Trial population
The study will enroll adult participants with a confirmed diagnosis of COPD. The population is composed of two distinct groups: inpatients who are currently hospitalized for a moderate/severe COPD exacerbation, and outpatients attending routine follow-up who are selected to enrich the sample with individuals who experience frequent exacerbations.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
50 Participants
are grouped into 2 trial groupsGroup A: Inpatients
Group B: Outpatients
Trial outcomes
Primary outcomes
1
Predictive accuracy of Hyfe cough monitoring for COPD exacerbations
(a) Positive predictive value (PPV) by time to exacerbation vs standard of care (SoC) (b) False positive and false negative rates by time to exacerbation vs SoC
Time frame
Up to 1 yearSecondary outcomes
1
Predictive accuracy: continuous vs. nighttime-only cough monitoring
Positive predictive value by time to exacerbation of continuous vs night-only monitoring
Time frame
Up to 1 year2
Predictive accuracy: cough data vs. combined cough and symptom data
Positive predictive value by time to exacerbation of cough monitoring with and without the COPD Assessment Test (CAT) questionnaire vs the standard of care
Time frame
Up to 1 year3
Estimated potential cost savings
Derived from hospitalization rate and 30-day readmission rates from standard of care vs the expected rates with earlier detection through cough monitoring should there be any
Time frame
Up to 1 year4
Usability and acceptability of the Hyfe monitoring system
Usability will be measured by participant adherence, calculated as the percentage of time the monitor is worn or actively charging. Acceptability will be assessed using a self-reported user satisfaction survey administered to participants at the end of their follow-up period
Time frame
Up to 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Clinica Universidad de Navarra, Universidad de Navarra
Lead sponsor
Hyfe Inc
Collaborator
Source ClinicalTrials.gov