ANNE Sensor Monitoring in Cystic Fibrosis

Cystic Fibrosis Clinical Trial

— ASM in CF  

Official title:

ASM in CF:ANNE Sensor Monitoring in Cystic Fibrosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05941832
• Other study ID #: P02784
• Status: Recruiting
• Start date: July 3, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: July 2023
• Source: Papworth Hospital NHS Foundation Trust
• Contact: Lucy Gale
• Phone: 01223638480
• Email: lucy.gale1[@]nhs.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Device:
• ANNE Chest Sensor
Wearing ANNE Chest Sensor for 6 weeks

Locations

Country	Name	City	State
United Kingdom	Royal Papworth Hospital	Cambridge	Cambridgeshire

Sponsors (3)

Lead Sponsor	Collaborator
Papworth Hospital NHS Foundation Trust	Cystic Fibrosis Trust, LifeArc

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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