Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 10:47 PM
Study NCT ID:
NCT05475067
Status:
COMPLETED
Last Update Posted:
2022-07-26
First Post:
2022-06-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fever Tracking Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-03-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-25', 'studyFirstSubmitDate': '2022-06-01', 'studyFirstSubmitQcDate': '2022-07-25', 'lastUpdatePostDateStruct': {'date': '2022-07-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Influence of age on the predicted CBT', 'timeFrame': '48 hours', 'description': 'Age measured in years'}, {'measure': 'Influence of sex on the predicted CBT', 'timeFrame': '48 hours'}, {'measure': 'Influence of weight on the predicted CBT', 'timeFrame': '48 hours', 'description': 'Weight measured in kg'}, {'measure': 'Influence of height on the predicten CBT', 'timeFrame': '48 hours', 'description': 'Height measured in cm'}, {'measure': 'Influence of skin colour on the predicted CBT', 'timeFrame': '48 hours', 'description': 'Skin colour measured on the Fitzpatrick Skin Type Scala which classifies skin types from I to VI, depending on the amount of melanin pigment. Type I contains the lowest level of melanin, whereas type VI has the highest level.'}, {'measure': 'Influence of hairiness on the predicted CBT', 'timeFrame': '48 hours', 'description': 'Degree of hairiness expressed as mild, moderate and strong'}, {'measure': 'Influence of food intake on the predicted CBT', 'timeFrame': '48 hours', 'description': 'The impact of the above mentioned factor on the CBT will be monitored and recorded in a participant diary'}, {'measure': 'Influence of concomitant medications on the predicted CBT', 'timeFrame': '48 hours', 'description': 'The impact of the above mentioned factors on the CBT will be monitored and recorded in a participant diary'}], 'primaryOutcomes': [{'measure': 'Mean absolute error, bias and standard deviation of the predicted CBT by the wearable CBT sensor compared to the reference temperature method (ingestible electronic pill)', 'timeFrame': '48 hours', 'description': 'This comparison will be done for each position of the wearable CBT sensor (apical, upper arm and wrist).'}], 'secondaryOutcomes': [{'measure': 'Mean absolute error, mean bias and standard deviation of the predicted CBT sensor compared to the reference temperature method (ingestible electronic pill).', 'timeFrame': '48 hours', 'description': 'In addition to the primary outcome measure, the heartrate will be used as additional input to perform the CBT prediction of the wearables.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fever Tracking', 'Core body temperature CBT', 'mRNA COVID-19 vaccination', 'Wearable sensors', 'Wearables'], 'conditions': ['Core Body Temperature in Healthy Subjects', 'Immune Response to mRNA COVID-19 Vaccination']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the feasibility of continuous fever tracking of participants having fever symptoms in a home setting, using a core body temperature (CBT) sensor. CBT as measured by the wearable sensors will be coampared with CBT as measured by ingestible electronc pills (reference).\n\nA secondary research question is, if the CBT behavior of the the participants in a home setting can be compared to previously described CBT profiles in the literature, and if special patterns can be identified.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects testing for COVID-19 at the University Hospital Basel and having acute fever symptoms, or individuals receiving the second shot or the booster of an mRNA COVID 19 vaccination, will be informed about the possibility to participate in this study by study personnel on-site.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-60 years old\n* Informed consent signed\n* Either:\n\nAcute fever symptoms at inclusion (at least 38.0°C) and Test for COVID-19 at the day of inclusion\n\n\\- Or: Second shot or booster of mRNA COVD-19 vaccination (Comirnaty® or COVID-19 Vaccine Moderna®) at day of inclusion\n\nExclusion Criteria:\n\n* Any participant who, for any reason, is unable to independently consent to participate in the study and/or who is unable to independently follow the study protocol.\n* Any participant with previous surgical procedures in the gastrointestinal tract\n* Inability to swallow pills\n* Any participant of ≤40 kg body weight\n* A scheduled MRI examination in the period from the start of the measurements until seven days after ingestion of the electronic pill.\n* Any participant being pregnant\n* Impairment or disability of the upper extremity likely to have a negative impact on the quality of measurements:\n\n * Wounds\n * Active venous access\n * Amputations\n * Dialysis shunt\n * Edema\n * Axillary dissection\n * Continuous long-term monitoring of blood pressure\n * Tattoos\n* Known allergy to plastics / latex\n* Language problems'}, 'identificationModule': {'nctId': 'NCT05475067', 'briefTitle': 'Fever Tracking Study', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Fever Tracking Study: The Feasibility of Fever Tracking in a Home-setting by a Non-invasive Wearable Core Body Temperature Sensor', 'orgStudyIdInfo': {'id': 'Fever Tracking'}}, 'contactsLocationsModule': {'locations': [{'zip': '4031', 'city': 'Basel', 'state': 'Canton of Basel-City', 'country': 'Switzerland', 'facility': 'Universitiy Hospital Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Jens Eckstein, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Basel, Switzerland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'collaborators': [{'name': 'greenTEG AG', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}