ANNE Sensor Monitoring in Cystic Fibrosis (ASM in CF)

ASM in CF:ANNE Sensor Monitoring in Cystic Fibrosis

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.

Study Overview

• Status: Completed
• Conditions: Cystic Fibrosis
• Intervention / Treatment: Device: ANNE Chest Sensor

Detailed Description

Rationale

The aim of this study is to explore the potential use of the ANNE Chest Sensor to assist or improve the detection of health conditions in people with CF. The emphasis is on identifying onset and progression of pulmonary exacerbations.

The ANNE Chest Sensor is now being applied to help people with respiratory and other conditions. Through advanced analytics and signal processing, the device includes an accelerometer, temperature sensor and electrocardiogram, from which vital signs such as respiratory rate, skin and body temperature, ECG, heart rate, step count, fall count and body position can be measured.

Royal Papworth Hospital has demonstrated that daily recordings of a range of physiological parameters (e.g., spirometry, pulse oximetry, activity, heart rate, etc.) in combination with self-reported survey responses (e.g., general wellness, cough, sleep quality) in people with CF holds promise to more accurately track fluctuations in health condition(s), in particular the start of pulmonary exacerbations (PE). This data is collected remotely at the study participant's home using remote/virtual online tools, as part of a larger effort to take a more virtual approach to clinics. Passive and continuous collection of a patient's data for early detection is a natural extension of this approach.

Study Design

This is a 6-month single-centre observational, prospective study, designed as a pilot study. We aim to recruit 10 adult patients with Cystic Fibrosis (CF) who are already participating in the Project Breathe home monitoring project at Royal Papworth Hospital. Participants will be enrolled for 6 weeks.

This study is designed to run as a non-disruptive study with no impact on routine clinical care and the sensor data will have no influence on treatment decisions.

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• United Kingdom
  • Cambridgeshire
    • Cambridge, Cambridgeshire, United Kingdom, CB2 0AA
      • Royal Papworth Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in Heart Rate (bpm) Measured by The ANNE Chest Sensor vs Current Heart Rate Home Monitoring	Number of beats per minute (bpm) measured by the ANNE Chest Sensor vs current home heart rate monitoring (bpm)	6 weeks
Difference in Oxygen Levels (%) Measured by The Anne Chest Sensor vs Current Oxygen Levels Home Measurements	Blood oxygen levels (%) measured by the ANNE Chest Sensor vs current home oxygen level monitoring (%)	6 weeks
Difference in Activity (kcal) Measured by The ANNE Chest Sensor vs Current Home Activity Monitoring	Kcal expended through exercise as measured by the ANNE Chest Sensor vs current home monitoring of activity (kcal)	6 weeks

Collaborators and Investigators

• Sponsor: Papworth Hospital NHS Foundation Trust
• Collaborators: LifeArc; Cystic Fibrosis Trust

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2023
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: July 4, 2023
• First Submitted That Met QC Criteria: July 4, 2023
• First Posted (Actual): July 12, 2023

Study Record Updates

• Last Update Posted (Actual): May 29, 2025
• Last Update Submitted That Met QC Criteria: May 22, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Genetic Diseases, Inborn; Respiratory Tract Diseases; Digestive System Diseases; Lung Diseases; Infant, Newborn, Diseases; Pancreatic Diseases; Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: P02784

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: This is undecided currently

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No