Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-28 @ 12:09 AM
Study NCT ID:
NCT04022460
Status:
UNKNOWN
Last Update Posted:
2021-08-05
First Post:
2019-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Using Personal Mobile Technology to Identify Obstructive Sleep Apnea in Children With Down Syndrome (UPLOAD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004314', 'term': 'Down Syndrome'}, {'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], 'ancestors': [{'id': 'D008607', 'term': 'Intellectual Disability'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000015', 'term': 'Abnormalities, Multiple'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D025063', 'term': 'Chromosome Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017286', 'term': 'Polysomnography'}], 'ancestors': [{'id': 'D008991', 'term': 'Monitoring, Physiologic'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 141}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-09-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2023-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-04', 'studyFirstSubmitDate': '2019-07-15', 'studyFirstSubmitQcDate': '2019-07-15', 'lastUpdatePostDateStruct': {'date': '2021-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Parental screening assessment of presence/absence of OSA based on homemade video clip', 'timeFrame': '1 day', 'description': 'Questionnaire developed at CHEO by Pediatric Respirologists and Otolaryngologists. The question of interest is "Do you think your child has obstructive sleep apnea?" The reviewer (a parent) will choose \'Yes\' or \'No\' after reviewing the homemade video clips. This is a dichotomous outcome with \'Yes\' considered as the highest score. The gold standard reference test will be a polysomnography.'}], 'secondaryOutcomes': [{'measure': 'Parental assessment of severity of OSA based on homemade video clip', 'timeFrame': '1 day', 'description': 'Questionnaire developed at CHEO by Pediatric Respirologists and Otolaryngologists. The question of interest is "Do you believe the severity of the obstructive sleep apnea is: a) Mild, b) Moderate, or c) Severe ?" This question will only appear to parents who chose \'Yes\' for the primary outcome. The reviewer will answer the question after reviewing the homemade video clips. This is an ordinal outcome with \'Mild\' being considered the lowest score (1), and \'Severe\' being considered the highest score (3). The gold standard reference test will be a polysomnography.'}, {'measure': 'Physician screening assessment of presence/absence of OSA based on homemade video clip', 'timeFrame': '1 day', 'description': 'Questionnaire developed at CHEO by Pediatric Respirologists and Otolaryngologists. The question of interest is "Do you think your child has obstructive sleep apnea?" Two physicians will independently choose \'Yes\' or \'No\' after reviewing the homemade video clips. This is a dichotomous outcome with \'Yes\' considered as the highest score. The gold standard reference test will be a polysomnography.'}, {'measure': 'Physician assessment of severity of OSA based on homemade video clip', 'timeFrame': '1 day', 'description': 'Questionnaire developed at CHEO by Pediatric Respirologists and Otolaryngologists. The question of interest is "Do you believe the severity of the obstructive sleep apnea is: a) Mild, b) Moderate, or c) Severe ?" This question will only appear to physicians who choose \'Yes\' for Outcome #3. The reviewer will answer the question after reviewing the homemade video clips. This is an ordinal outcome with \'Mild\' being considered the lowest score (1), and \'Severe\' being considered the highest score (3). The gold standard reference test will be a polysomnography.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Polysomnography', 'Pediatric', 'Down syndrome', 'Obstructive sleep apnea', 'Screening tool', 'Mobile technology'], 'conditions': ['Down Syndrome', 'Obstructive Sleep Apnea', 'Child']}, 'descriptionModule': {'briefSummary': 'This study aims to see if mobile video clips (smartphone recordings) can be used to screen children with Down syndrome to identify those at highest risk of obstructive sleep apnea (OSA), so they can be prioritized for an earlier sleep study. Parents will be asked to record short video clips of their child sleeping, and then rate whether they think their child has OSA. Later, children will undergo a sleep study to compare to the ratings.', 'detailedDescription': "Children with Down syndrome have approximately a 50% chance of developing obstructive sleep apnea (OSA) in their lifetime. OSA is a serious condition where a person stops breathing periodically during sleep; it is associated with high blood pressure, behavioural issues, and lower quality of life. Early diagnosis and treatment is critical, but the best way to diagnose OSA, a 'sleep study', is in short supply. Given the limited resources, this study aims to see if mobile video clips (smartphone recordings) can be used to screen children with Down syndrome to identify those at highest risk of OSA, so they can be prioritized for an earlier sleep study.\n\nParents of children with Down syndrome, recruited from clinic, will be asked to record short video clips of their child sleeping. Parents will independently rate whether they think their child has OSA and how severe it is, based on the videos, as will two clinicians. Parents will also watch an educational webinar and be asked to re-rate the presence and severity of OSA in their child, to see if the webinar improves their accuracy. Finally, children will undergo a sleep study to compare to the ratings. This study will help determine whether videos can be used to accurately screen for OSA in this high risk population, prioritizing children for earlier diagnosis and treatment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '2 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "The study population will consist of children with Down syndrome who have not previously been diagnosed with sleep-disordered breathing. We will approach children followed at the CHEO Down Syndrome clinic to participate in this study. All children within CHEO's catchment area will be considered eligible for this study.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of Down syndrome\n* Within the catchment area of the Children's Hospital of Eastern Ontario Down Syndrome clinic\n\nExclusion Criteria:\n\n* Previous diagnosis of sleep-disordered breathing on polysomnography\n* No access to mobile technology to record video clips\n* Children unable to cooperate for polysomnography\n* Caregiver does not speak French or English"}, 'identificationModule': {'nctId': 'NCT04022460', 'acronym': 'UPLOAD', 'briefTitle': 'Using Personal Mobile Technology to Identify Obstructive Sleep Apnea in Children With Down Syndrome (UPLOAD)', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital of Eastern Ontario"}, 'officialTitle': 'Using Personal Mobile Technology to Identify Obstructive Sleep Apnea in Children With Down Syndrome (UPLOAD)', 'orgStudyIdInfo': {'id': '19/30X'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Video clip assessment', 'type': 'DIAGNOSTIC_TEST', 'description': 'Parents will take short video clips of their child sleeping at night. They will be asked to review the video clips and rate whether they think their child has obstructive sleep apnea (OSA), and if so, how severe it is. Two clinicians will review the video clips on a separate night.'}, {'name': 'Polysomnography (sleep study)', 'type': 'DIAGNOSTIC_TEST', 'description': 'Children will undergo a polysomnography as the gold standard test to assess for OSA.'}, {'name': 'Educational webinar', 'type': 'OTHER', 'description': 'After evaluating the video clips of their child sleeping, parents will watch an educational webinar on OSA in children with Down syndrome and how to recognize symptoms.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'K1H8L1', 'city': 'Ottawa', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Henrietta Blinder', 'role': 'CONTACT', 'email': 'hblinder@cheo.on.ca', 'phone': '6137377600', 'phoneExt': '4026'}, {'name': 'Sherri L Katz, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Children's Hospital of Eastern Ontario", 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}], 'centralContacts': [{'name': 'Henrietta Blinder', 'role': 'CONTACT', 'email': 'hblinder@cheo.on.ca', 'phone': '613-737-7600', 'phoneExt': '4026'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital of Eastern Ontario", 'class': 'OTHER'}, 'collaborators': [{'name': "The Physicians' Services Incorporated Foundation", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief, Division of Pediatric Respirology', 'investigatorFullName': 'Sherri Katz', 'investigatorAffiliation': "Children's Hospital of Eastern Ontario"}}}}