Smart wearable could predict COPD Flare-Ups before they happen
NCT ID NCT05655832
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested whether a wearable device (Vivalink) could track health signs like heart rate, breathing, and activity in people with COPD. 77 participants wore the device for 3 months to see if the data could predict when symptoms would get worse. The goal was to find a way to monitor COPD at home and catch flare-ups early.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Vivalink wearable device
- What this could lead to
- If successful, this could lead to a way for people with COPD to monitor their condition at home and get early warnings of worsening symptoms.
- What could go wrong
- This was a small, completed study that only looked at whether the device data matches standard measures. It does not prove the device can prevent or treat COPD flare-ups.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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77 people
The number who actually took part.
- Started
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Dec 2022
- Finished
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Oct 2023
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: For participants with COPD: * Participants ≥40 and ≤80 years at baseline * Diagnosis of COPD stage II to IV * History of moderate or severe exacerbations (≥2 moderate exacerbations or ≥1 severe exacerbations in any 12-month time window during last 3 years prior to inclusion and ≥1 moderate or severe exacerbations in the last 12 months prior to inclusion, considering that the last 12 months may reflect lower exacerbation rate due to Covid-19 measures) For participants in the calibration cohort: • Participants ≥40 and ≤80 years at baseline Exclusion Criteria: For participants with COPD: * Clinically relevant and/or serious concurrent medical conditions including, but not limited to visual problems, severe mental illness or cognitive impairment, musculoskeletal or movement disorders, cardiac disease (e.g., heart failure, arrythmia \[esp. atrial fibrillation and conduction blocks\]), lung cancer (currently treated) that in the opinion of the Investigator, would interfere with participant's ability to participate in the study or draw meaningful conclusions from the study * Participants with a cardiac pacemaker, defibrillators, or other implanted electronic devices * Participants with known allergies or sensitivity to silicon or hydrogel * Less than 6 weeks since previous moderate/severe exacerbation For participants in the calibration cohort: * Participants with a cardiac pacemaker, defibrillators, or other implanted electronic devices * Participants with known allergies or sensitivity to silicon or hydrogel * Diagnosis of pulmonary disease including, but not limited to COPD, asthma, pulmonary fibrosis, with impact on the lung function and exercise capacity
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Lungenpraxis Dr. Franz / Dr. Weber
Witten, Germany
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Lungenzentrum Darmstadt GmbH
Darmstadt, Germany
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Lungenzentrum Frankfurt
Frankfurt, Germany
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Pneumologische Gemeinschaftspraxis Saarbrücken
Saarbrücken, Germany
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Pneumologische Praxis Wiesbaden
Wiesbaden, Germany
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Pneumologisches Studienzentrum München-West
München, Germany
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Praxis an der Oper
Berlin, Germany
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RespiRatio / Lungenpraxis
Schleswig, Germany
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Städtische Kliniken Darmstadt
Darmstadt, Germany
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Thoraxklinik Heidelberg gGmbH
Heidelberg, Germany
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ZERO Praxen
Mannheim, Germany
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