Ignite Creation Date:
2025-12-24 @ 9:50 PM
Ignite Modification Date:
2026-01-02 @ 9:03 AM
Study NCT ID:
NCT05941832
Status:
COMPLETED
Last Update Posted:
2025-05-29
First Post:
2023-07-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ANNE Sensor Monitoring in Cystic Fibrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-07-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-22', 'studyFirstSubmitDate': '2023-07-04', 'studyFirstSubmitQcDate': '2023-07-04', 'lastUpdatePostDateStruct': {'date': '2025-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With ANNE Sensor Related Adverse Skin Sensitivity Events', 'timeFrame': '6 weeks', 'description': 'Number of ANNE sensor related Adverse Events reported during the study'}], 'secondaryOutcomes': [{'measure': 'Difference in Heart Rate (bpm) Measured by The ANNE Chest Sensor vs Current Heart Rate Home Monitoring', 'timeFrame': '6 weeks', 'description': 'Number of beats per minute (bpm) measured by the ANNE Chest Sensor vs current home heart rate monitoring (bpm)'}, {'measure': 'Difference in Oxygen Levels (%) Measured by The Anne Chest Sensor vs Current Oxygen Levels Home Measurements', 'timeFrame': '6 weeks', 'description': 'Blood oxygen levels (%) measured by the ANNE Chest Sensor vs current home oxygen level monitoring (%)'}, {'measure': 'Difference in Activity (kcal) Measured by The ANNE Chest Sensor vs Current Home Activity Monitoring', 'timeFrame': '6 weeks', 'description': 'Kcal expended through exercise as measured by the ANNE Chest Sensor vs current home monitoring of activity (kcal)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cystic Fibrosis']}, 'descriptionModule': {'briefSummary': '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.\n\nParticipants 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.', 'detailedDescription': "Rationale\n\nThe 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.\n\nThe 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.\n\nRoyal 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.\n\nStudy Design\n\nThis 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.\n\nThis 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults with Cystic Fibrosis who are being treated at Royal Papworth Hospital Cystic Fibrosis Specialist Centre.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of Cystic Fibrosis based on genetic testing and /or sweat chloride levels.\n* At least \\>/= 18 years of age at time of consent\n* Able to provide written informed consent\n* Patients who are currently undertaking home monitoring / virtual clinics as part of Project Breathe\n\nExclusion Criteria:\n\n* Patients unable to provide written informed consent\n* Patients who are currently not undertaking home monitoring / virtual clinics as part of Project Breathe\n* Lung transplant recipients.\n* Severe skin conditions e.g. psoriasis, severe eczema\n* Patients with a pacemaker'}, 'identificationModule': {'nctId': 'NCT05941832', 'acronym': 'ASM in CF', 'briefTitle': 'ANNE Sensor Monitoring in Cystic Fibrosis', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Papworth Hospital NHS Foundation Trust'}, 'officialTitle': 'ASM in CF:ANNE Sensor Monitoring in Cystic Fibrosis', 'orgStudyIdInfo': {'id': 'P02784'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ANNE Chest Sensor', 'type': 'DEVICE', 'description': 'Wearing ANNE Chest Sensor for 6 weeks'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CB2 0AA', 'city': 'Cambridge', 'state': 'Cambridgeshire', 'country': 'United Kingdom', 'facility': 'Royal Papworth Hospital', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'This is undecided currently'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Papworth Hospital NHS Foundation Trust', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'LifeArc', 'class': 'OTHER'}, {'name': 'Cystic Fibrosis Trust', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}