Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-26 @ 12:41 AM
Study NCT ID:
NCT04071860
Status:
COMPLETED
Last Update Posted:
2022-09-28
First Post:
2019-03-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Developing a Non-contact Sleep Apnoea Detector, Suitable for Home Studies- The Safescan Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], 'ancestors': [{'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 445}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2021-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-27', 'studyFirstSubmitDate': '2019-03-04', 'studyFirstSubmitQcDate': '2019-08-27', 'lastUpdatePostDateStruct': {'date': '2022-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Agreement between the Apnoea hypopnea index (AHI) per hour as measured overnight by the Safescan device and by clinical polysomnography', 'timeFrame': 'overnight (8-10 hours)', 'description': "Agreement in AHI +/- 10% between Safescan device and PSG. A comparison will be made between the 2 AHI's for each participant. The proportion in whom there is an agreement within +/- 10% will be reported."}], 'secondaryOutcomes': [{'measure': 'Agreement between the Safescan device respiratory rate (RR) as breaths per minute overnight and RR from PSG', 'timeFrame': 'overnight (8-10 hours)', 'description': 'Agreement +/- 1 breath per minute between Safescan device and PSG'}, {'measure': 'Agreement in recorded body position between Safescan device and PSG', 'timeFrame': 'overnight (8-10 hours)', 'description': 'Percentage of 1 minute epochs during the the Safescan body position is in agreement with that of the PSG'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sleep Apnoea', 'Obstructive Sleep Apnoea']}, 'descriptionModule': {'briefSummary': 'Sleep apnoea (SA) is a common condition in adults and children that causes disturbed sleep and daytime symptoms. It is characterised by disrupted breathing with disturbed sleep patterns. In adults this can lead to dangerous daytime sleepiness affecting for example driving performance. In children it may lead to hyperactivity in the day and poor school performance. There are a number of techniques for diagnosing the disorder but they can affect the quality of sleep which sometimes makes them inaccurate. Most are unsuitable for small children who cannot understand the value of the tests and tend to remove the monitoring wires and devices in the night. This study aims to validate a new non contact device "Safescan", based on low power radar technology, which can be put under a bed and record breathing patterns with no measuring device in contact with the sleeper. In this initial study the device will be validated in adults, against the gold standard of polysomnography (PSG) in the sleep laboratory at Royal Papworth Hospital.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients referred to the sleep laboratory for inpatient polysomnography, irrespective of working or known diagnosis.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18 years or older\n* Able to give informed consent\n\nExclusion Criteria:\n\n* Patient with known sleep disordered breathing using a treatment device (e.g. continuous positive airway pressure) on the night of the study.\n* Polysomnography study records less than 4 hours of respiratory data'}, 'identificationModule': {'nctId': 'NCT04071860', 'briefTitle': 'Developing a Non-contact Sleep Apnoea Detector, Suitable for Home Studies- The Safescan Study', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Papworth Hospital NHS Foundation Trust'}, 'officialTitle': 'Developing a Non-contact Sleep Apnoea Detector, Suitable for Home Studies- The Safescan Study.', 'orgStudyIdInfo': {'id': 'P02423'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'discovery and learning cohort', 'description': 'Data from this cohort will be used to develop the software algorithms'}, {'label': 'Validation', 'description': 'Data from this cohort will be used to validate the software algorithms'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CB2 0AY', 'city': 'Cambridge', 'state': 'Cambridgeshire', 'country': 'United Kingdom', 'facility': 'Royal Papworth Hospital', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}], 'overallOfficials': [{'name': 'Ian Smith, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Royal Papworth Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Papworth Hospital NHS Foundation Trust', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Iceni Labs Ltd, Warwickshire, United Kingdom', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}