Cystic FibrosisASM in CFNCT05941832
ANNE Sensor Monitoring in Cystic Fibrosis
An observational study of Cystic Fibrosis, run by Papworth Hospital NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- ANNE Chest Sensor
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Jul 2023to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with Cystic Fibrosis who are being treated at Royal Papworth Hospital Cystic Fibrosis Specialist Centre.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Papworth Hospital
Cambridge, Cambridgeshire, CB2 0AA
About this study
Official title: 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.
Read the 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.
- Conditions
- Cystic Fibrosis
- Being tested
- ANNE Chest Sensor
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANNE Chest SensorDevice
Wearing ANNE Chest Sensor for 6 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With ANNE Sensor Related Adverse Skin Sensitivity Events
Number of ANNE sensor related Adverse Events reported during the study
Measured: 6 weeks
Secondary outcomes (3)
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)
Measured: 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 (%)
Measured: 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)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start3 Jul 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Papworth Hospital NHS Foundation Trust
- Sponsor type
- Other government
- Collaborators
- LifeArc, Cystic Fibrosis Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05941832
- Sponsor's protocol ID
- P02784
- Acronym
- ASM in CF
- Status last verified
- May 2025
- First submitted
- 4 Jul 2023
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This is undecided currently
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASM in CF:ANNE Sensor Monitoring in Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT05941832
- Acronym / sponsor ID
- ASM in CF / P02784
- Conditions
- Cystic Fibrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Papworth Hospital NHS Foundation TrustOther government
- Collaborators
- LifeArc, Cystic Fibrosis Trust
- Study start
- 3 Jul 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 12 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with Cystic Fibrosis who are being treated at Royal Papworth Hospital Cystic Fibrosis Specialist Centre.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ANNE Chest SensorWearing ANNE Chest Sensor for 6 weeks | Device | – |
Primary outcome
Number of Participants With ANNE Sensor Related Adverse Skin Sensitivity Events
Time frame: 6 weeks
Number of ANNE sensor related Adverse Events reported during the study
3 secondary outcomes
Difference in Heart Rate (bpm) Measured by The ANNE Chest Sensor vs Current Heart Rate Home Monitoring
Time frame: 6 weeks
Difference in Oxygen Levels (%) Measured by The Anne Chest Sensor vs Current Oxygen Levels Home Measurements
Time frame: 6 weeks
Difference in Activity (kcal) Measured by The ANNE Chest Sensor vs Current Home Activity Monitoring
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Individual participant dataSharing planned: Undecided. This is undecided currently
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis, run by Papworth Hospital NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With ANNE Sensor Related Adverse Skin Sensitivity Events (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2025.