Novel Sensors and Artificial Intelligence for Detection of Acute Pulmonary Exacerbations in Cystic Fibrosis and Bronchiectasis

NCT07289100 | Recruiting

• 2 other identifiers: P03178IRAS 357389
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to learn about new sensors that measure changes in the body that happen during a chest infection, such as breathing rate and heart rate. This study will be with adults who have either cystic fibrosis or bronchiectasis who start treatment with intravenous antibiotics (usually for around 2 weeks). The main question it aims to answer is the change in sensor measure (such as heart rate) between the start and end of treatment for a chest infection. No follow up visits are required for this study.

Conditions

Cystic Fibrosis (CF); Bronchiectasis Adult

Keywords

cystic fibrosis; bronchiectasis; acute; exacerbation; respiratory; pulmonary; observational; prospective; cohort; feasibility; umbrella

Outcome Measures

Primary Outcomes (1)

• The change in physiological parameter measure such as heart rate (sensor dependant) between the start and end of intravenous antibiotics for acute pulmonary exacerbation.

  mean of parameter (e.g. heart rate) taken from first 2 days of IV antibiotics vs the last 2 days of antibiotics will be compared

  from enrolment to the end of treatment at 14 days (may be 10-21 days depending on length of treatment course)

Interventions

Non-Interventional Study OTHER

non-interventional

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted under the specialist care of Royal Papworth Hospital Foundation Trust, Cambridge, UK

You may qualify if:

• ≥ 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Papworth Hospital NHS Foundation Trust: lead
• LifeArc: collaborator
• University of Cambridge: collaborator
• Department of Health, United Kingdom: collaborator
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (1)

Royal Papworth Hospital NHS Foundation Trust

Cambridge, Cambridgeshire, CB2 0AY, United Kingdom

RECRUITING

MeSH Terms

Conditions

Cystic Fibrosis; Bronchiectasis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Bronchial Diseases

Study Officials

• Andres Floto

  University of Cambridge

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lucy E Gale

CONTACT

+44 1223 638000; lucy.gale1@nhs.net

Victoria Hughes, PhD

CONTACT

+44 1223 638000; victoria.hughes1@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 17, 2025
• Study Start: September 30, 2025
• Primary Completion: March 31, 2026
• Study Completion: April 30, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Locations

GB (1)