Clinical trial NCT05941832: ANNE Sensor Monitoring in Cystic Fibrosis
Official title: ASM in CF:ANNE Sensor Monitoring in Cystic Fibrosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis
Lead sponsor: Papworth Hospital NHS Foundation Trust
Sponsor class: OTHER_GOV
Collaborators: name: LifeArc
name: Cystic Fibrosis Trust
First posted: 2023-07-12
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with Cystic Fibrosis who are being treated at Royal Papworth Hospital Cystic Fibrosis Specialist Centre.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With ANNE Sensor Related Adverse Skin Sensitivity Events
timeFrame: 6 weeks
Secondary outcomes:
measure: Difference in Heart Rate (bpm) Measured by The ANNE Chest Sensor vs Current Heart Rate Home Monitoring
timeFrame: 6 weeks
measure: Difference in Oxygen Levels (%) Measured by The Anne Chest Sensor vs Current Oxygen Levels Home Measurements
timeFrame: 6 weeks
measure: Difference in Activity (kcal) Measured by The ANNE Chest Sensor vs Current Home Activity Monitoring
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Royal Papworth Hospital
state: Cambridgeshire
Study officials:
References: