ANNE Sensor Monitoring in Cystic Fibrosis

NCT05941832 | Completed

• 1 other identifier: P02784
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The ANNE sensor is a small, wire free device that is placed on the chest with a removable adhesive patch. It measures things like temperature, heart rate and breathing rate without the need for wires and large machines that are needed currently. The aim is to trial this sensor in a small group of participants to see how well it is tolerated and how well it measures. The aim is to see if the sensor could provide additional information to help the medical team detect when a participant is becoming unwell with less need for the participant to perform repeated tests. Participants will wear the sensor for 6 weeks continuously (apart from when it is charged for 4-6 hours each day). Participants can perform their usual activities whilst wearing the sensor but should not submerse the sensor in water for long periods of time.

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

• Number of Participants With ANNE Sensor Related Adverse Skin Sensitivity Events

  Number of ANNE sensor related Adverse Events reported during the study

  6 weeks

Secondary Outcomes (3)

• Difference in Heart Rate (bpm) Measured by The ANNE Chest Sensor vs Current Heart Rate Home Monitoring

  6 weeks

• Difference in Oxygen Levels (%) Measured by The Anne Chest Sensor vs Current Oxygen Levels Home Measurements

  6 weeks

• Difference in Activity (kcal) Measured by The ANNE Chest Sensor vs Current Home Activity Monitoring

  6 weeks

Interventions

ANNE Chest Sensor DEVICE

Wearing ANNE Chest Sensor for 6 weeks

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

Adults with Cystic Fibrosis who are being treated at Royal Papworth Hospital Cystic Fibrosis Specialist Centre.

You may qualify if:

• Diagnosis of Cystic Fibrosis based on genetic testing and /or sweat chloride levels.
• At least \>/= 18 years of age at time of consent
• Able to provide written informed consent
• Patients who are currently undertaking home monitoring / virtual clinics as part of Project Breathe

You may not qualify if:

• Patients unable to provide written informed consent
• Patients who are currently not undertaking home monitoring / virtual clinics as part of Project Breathe
• Lung transplant recipients.
• Severe skin conditions e.g. psoriasis, severe eczema
• Patients with a pacemaker

Sponsors & Collaborators

• Papworth Hospital NHS Foundation Trust: lead
• LifeArc: collaborator
• Cystic Fibrosis Trust: collaborator

Study Sites (1)

Royal Papworth Hospital

Cambridge, Cambridgeshire, CB2 0AA, United Kingdom

Location

MeSH Terms

Conditions

Cystic Fibrosis

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

Study Design

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

Study Record Dates

• First Submitted: July 4, 2023
• First Posted: July 12, 2023
• Study Start: July 3, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: May 29, 2025

Record last verified: 2025-05

Locations

GB (1)