Wearable sensors and AI to detect chest infection flare-ups in adults with cystic fibrosis or bronchiectasis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study enrolls adults with cystic fibrosis or CT-confirmed non-CF bronchiectasis who are starting intravenous antibiotics for an acute pulmonary exacerbation. Participants will use novel sensors that record physiologic signals such as breathing rate and heart rate while clinical data are collected at the start and end of treatment. Artificial intelligence methods will be applied to the sensor data to look for measurable changes that correlate with the exacerbation and its resolution. There are no scheduled follow-up visits beyond the treatment episode and home monitoring data will be linked anonymised for research.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* ≥ 18 years old
* Diagnosis of CF based on genetic testing and /or sweat chloride levels or CT confirmed diagnosis of non-CF bronchiectasis
* Under the care of Royal Papworth Hospital
* Starting IV antibiotics for treatment of APE as defined by the Hill Criteria ²

Exclusion Criteria:

* Patients unable to provide written informed consent
* Lung transplant recipients or on lung transplant waiting list
* Use of long-term oxygen therapy (LTOT) or non-invasive ventilation to manage respiratory failure
* Patients unwilling to consent to their link anonymised data from home monitoring being used for research
* Considered unsuitable for home monitoring in the opinion of the investigator
* Patients being admitted for elective antibiotic treatment (i.e. not being admitted for acute APE treatment)

Where it's running

• Royal Papworth Hospital NHS Foundation Trust
  Cambridge, Cambridgeshire, United Kingdom Recruiting

Study contacts

• Principal investigator: Andres Floto — University of Cambridge
• Study coordinator: Lucy E Gale
• Email: lucy.gale1@nhs.net
• Phone: +44 1223 638000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.