Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2026-01-07 @ 9:08 PM
Study NCT ID:
NCT02967367
Status:
COMPLETED
Last Update Posted:
2020-03-24
First Post:
2016-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Reliability of Consumer Sleep Trackers in Patients Suffering From Obstructive Sleep Apnea Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], 'ancestors': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'marie_bruyneel@stpierre-bru.be', 'phone': '00325354219', 'title': 'Pr. Marie Bruyneel', 'organization': 'CHU Saint-pierre'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'one night, up to 600 minutes', 'description': '22 participants were at risk for any adverse events, as usually described', 'eventGroups': [{'id': 'EG000', 'title': 'Jawbone/Withings Sleep Trackers, Bodymedia Sensewear', 'description': '2 types of Consumer sleep trackers, including Jawbone and Withings, and one research actigraph (Bodymedia Sensewear) are added to classical polysomnography in order to assess their accuracy to measure sleep parameters in obstructive sleep apnea patients\n\nJawbone sleep tracker: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient\n\nWithings sleep tracker: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient\n\nBodyMedia Sense Wear accelerometer: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time in Bed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Jawbone/Withings Sleep Trackers, Bodymedia Sensewear', 'description': '2 types of Consumer sleep trackers, including Jawbone and Withings, and one research actigraph (Bodymedia Sensewear) are added to classical polysomnography in order to assess their accuracy to measure sleep parameters in obstructive sleep apnea patients\n\nJawbone sleep tracker: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient\n\nWithings sleep tracker: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient\n\nBodyMedia Sense Wear accelerometer: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient'}], 'classes': [{'title': 'PSG', 'categories': [{'measurements': [{'value': '519', 'spread': '34', 'groupId': 'OG000'}]}]}, {'title': 'Bodymedia Sensewear', 'categories': [{'measurements': [{'value': '446', 'spread': '86', 'groupId': 'OG000'}]}]}, {'title': 'Jawbone sleep tracker', 'categories': [{'measurements': [{'value': '522', 'spread': '45', 'groupId': 'OG000'}]}]}, {'title': 'Withings sleep tracker', 'categories': [{'measurements': [{'value': '524', 'spread': '122', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'one night (up to 600 minutes)', 'description': 'time spent in bed during the night (minutes)', 'unitOfMeasure': 'min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Sleep Efficiency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Jawbone/Withings Sleep Trackers, Bodymedia Sensewear', 'description': '2 types of Consumer sleep trackers, including Jawbone and Withings, and one research actigraph (Bodymedia Sensewear) are added to classical polysomnography in order to assess their accuracy to measure sleep parameters in obstructive sleep apnea patients\n\nJawbone sleep tracker: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient\n\nWithings sleep tracker: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient\n\nBodyMedia Sense Wear accelerometer: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient'}], 'classes': [{'title': 'PSG', 'categories': [{'measurements': [{'value': '67', 'spread': '18', 'groupId': 'OG000'}]}]}, {'title': 'Bodymedia Sensewear', 'categories': [{'measurements': [{'value': '80', 'spread': '14', 'groupId': 'OG000'}]}]}, {'title': 'Jawbone sleep tracker', 'categories': [{'measurements': [{'value': '78', 'spread': '13', 'groupId': 'OG000'}]}]}, {'title': 'Withings sleep tracker', 'categories': [{'measurements': [{'value': '84', 'spread': '11', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'one night (up to 600 minutes)', 'description': 'a percentage corresponding to total sleep time divided by time in bed', 'unitOfMeasure': 'percentage of time in bed', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Total Sleep Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Jawbone/Withings Sleep Trackers, Bodymedia Sensewear', 'description': '2 types of Consumer sleep trackers, including Jawbone and Withings, and one research actigraph (Bodymedia Sensewear) are added to classical polysomnography in order to assess their accuracy to measure sleep parameters in obstructive sleep apnea patients\n\nJawbone sleep tracker: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient\n\nWithings sleep tracker: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient\n\nBodyMedia Sense Wear accelerometer: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient'}], 'classes': [{'title': 'PSG', 'categories': [{'measurements': [{'value': '344', 'spread': '92', 'groupId': 'OG000'}]}]}, {'title': 'Bodymedia Sensewear', 'categories': [{'measurements': [{'value': '358', 'spread': '90', 'groupId': 'OG000'}]}]}, {'title': 'Jawbone sleep tracker', 'categories': [{'measurements': [{'value': '407', 'spread': '60', 'groupId': 'OG000'}]}]}, {'title': 'Withings sleep tracker', 'categories': [{'measurements': [{'value': '431', 'spread': '68', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'one night (up to 600 minutes)', 'description': 'time spent sleeping during the night (minutes)', 'unitOfMeasure': 'min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Deep Sleep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Jawbone/Withings Sleep Trackers, Bodymedia Sensewear', 'description': '2 types of Consumer sleep trackers, including Jawbone and Withings, and one research actigraph (Bodymedia Sensewear) are added to classical polysomnography in order to assess their accuracy to measure sleep parameters in obstructive sleep apnea patients\n\nJawbone sleep tracker: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient\n\nWithings sleep tracker: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient\n\nBodyMedia Sense Wear accelerometer: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient'}], 'classes': [{'title': 'PSG', 'categories': [{'measurements': [{'value': '83', 'spread': '51', 'groupId': 'OG000'}]}]}, {'title': 'Jawbone sleep tracker', 'categories': [{'measurements': [{'value': '243', 'spread': '74', 'groupId': 'OG000'}]}]}, {'title': 'Withings sleep tracker', 'categories': [{'measurements': [{'value': '192', 'spread': '84', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'one night (up to 600 minutes)', 'description': 'a percentage corresponding to sleep time spent in deep sleep (stage N3 on polysomnography) divided by total sleep time', 'unitOfMeasure': 'a percentage of total sleep time', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Light Sleep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Jawbone/Withings Sleep Trackers, Bodymedia Sensewear', 'description': '2 types of Consumer sleep trackers, including Jawbone and Withings, and one research actigraph (Bodymedia Sensewear) are added to classical polysomnography in order to assess their accuracy to measure sleep parameters in obstructive sleep apnea patients\n\nJawbone sleep tracker: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient\n\nWithings sleep tracker: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient\n\nBodyMedia Sense Wear accelerometer: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient'}], 'classes': [{'title': 'PSG', 'categories': [{'measurements': [{'value': '190', 'spread': '85', 'groupId': 'OG000'}]}]}, {'title': 'Jawbone sleep tracker', 'categories': [{'measurements': [{'value': '163', 'spread': '69', 'groupId': 'OG000'}]}]}, {'title': 'Withings sleep tracker', 'categories': [{'measurements': [{'value': '239', 'spread': '54', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'one night (up to 600 minutes)', 'description': 'a percentage corresponding to sleep time spent in light sleep (stage N1 and N2 on polysomnography) divided by total sleep time', 'unitOfMeasure': 'a percentage of total sleep time', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Jawbone/Withings Sleep Trackers, Bodymedia Sensewear', 'description': '2 types of Consumer sleep trackers, including Jawbone and Withings, and one research actigraph (Bodymedia Sensewear) are added to classical polysomnography in order to assess their accuracy to measure sleep parameters in obstructive sleep apnea patients\n\nJawbone sleep tracker: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient\n\nWithings sleep tracker: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient\n\nBodyMedia Sense Wear accelerometer: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Jawbone/Withings Sleep Trackers, Bodymedia Sensewear', 'description': '2 types of Consumer sleep trackers, including Jawbone and Withings, and one research actigraph (Bodymedia Sensewear) are added to classical polysomnography in order to assess their accuracy to measure sleep parameters in obstructive sleep apnea patients\n\nJawbone sleep tracker: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient\n\nWithings sleep tracker: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient\n\nBodyMedia Sense Wear accelerometer: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '53', 'spread': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-01-24', 'size': 103453, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-01-24T10:15', 'hasProtocol': True}, {'date': '2020-01-24', 'size': 110008, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-01-24T10:16', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-12', 'studyFirstSubmitDate': '2016-09-05', 'resultsFirstSubmitDate': '2019-02-07', 'studyFirstSubmitQcDate': '2016-11-15', 'lastUpdatePostDateStruct': {'date': '2020-03-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-03-12', 'studyFirstPostDateStruct': {'date': '2016-11-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time in Bed', 'timeFrame': 'one night (up to 600 minutes)', 'description': 'time spent in bed during the night (minutes)'}, {'measure': 'Sleep Efficiency', 'timeFrame': 'one night (up to 600 minutes)', 'description': 'a percentage corresponding to total sleep time divided by time in bed'}, {'measure': 'Total Sleep Time', 'timeFrame': 'one night (up to 600 minutes)', 'description': 'time spent sleeping during the night (minutes)'}], 'secondaryOutcomes': [{'measure': 'Deep Sleep', 'timeFrame': 'one night (up to 600 minutes)', 'description': 'a percentage corresponding to sleep time spent in deep sleep (stage N3 on polysomnography) divided by total sleep time'}, {'measure': 'Light Sleep', 'timeFrame': 'one night (up to 600 minutes)', 'description': 'a percentage corresponding to sleep time spent in light sleep (stage N1 and N2 on polysomnography) divided by total sleep time'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Obstructive Sleep Apnea Syndrome']}, 'descriptionModule': {'briefSummary': 'During last years, numerous sleep trackers have been commercialized. They are intended to give indications about sleep quality/duration in order to give people an internet-based feedback about their own sleep.\n\nFor clinical and research purposes, tri-axial accelerometers/multi-sensors devices are used routinely to assess objective sleep quality/patterns. Their use is also validated to estimate sleep in obstructive sleep apnea syndrome (OSA).\n\nThe purpose of the present study is to compare the accuracy of consumer-level sleep trackers and validated tools to measure sleep in OSA patients.', 'detailedDescription': 'During last years, numerous sleep trackers have been commercialized. They are working on accelerometer-based technology. They are intended to give indications about sleep quality/duration in order to give people an internet-based feedback about their own sleep..\n\nFor clinical and research purposes, tri-axial accelerometers/multi-sensors devices are used routinely to assess objective sleep quality/patterns. Their use is also validated to estimate sleep in obstructive sleep apnea syndrome (OSA).\n\nThe purpose of our study is to compare the accuracy of consumer-level sleep trackers and validated tools to measure sleep in OSA patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* high clinical suspicion of obstructive sleep apnea syndrome\n\nExclusion Criteria:\n\n* other associated sleep disorder\n* inability to sign informed consent'}, 'identificationModule': {'nctId': 'NCT02967367', 'briefTitle': 'Reliability of Consumer Sleep Trackers in Patients Suffering From Obstructive Sleep Apnea Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Saint Pierre'}, 'officialTitle': 'Reliability of Consumer Sleep Trackers in Patients Suffering From Obstructive Sleep Apnea Syndrome', 'orgStudyIdInfo': {'id': 'AK/15-06-67/4522'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Jawbone/Withings sleep trackers, Bodymedia Sensewear', 'description': '2 types of Consumer sleep trackers, including Jawbone and Withings, and one research actigraph (Bodymedia Sensewear) are added to classical polysomnography in order to assess their accuracy to measure sleep parameters in obstructive sleep apnea patients', 'interventionNames': ['Device: Jawbone sleep tracker', 'Device: Withings sleep tracker', 'Device: BodyMedia Sense Wear accelerometer']}], 'interventions': [{'name': 'Jawbone sleep tracker', 'type': 'DEVICE', 'otherNames': ['accelerometer'], 'description': 'During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient', 'armGroupLabels': ['Jawbone/Withings sleep trackers, Bodymedia Sensewear']}, {'name': 'Withings sleep tracker', 'type': 'DEVICE', 'description': 'During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient', 'armGroupLabels': ['Jawbone/Withings sleep trackers, Bodymedia Sensewear']}, {'name': 'BodyMedia Sense Wear accelerometer', 'type': 'DEVICE', 'description': 'During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient', 'armGroupLabels': ['Jawbone/Withings sleep trackers, Bodymedia Sensewear']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'CHu Saint Pierre', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'overallOfficials': [{'name': 'Marie Bruyneel, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire Saint Pierre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Saint Pierre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}