Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 11:27 PM
Study NCT ID:
NCT00928993
Status:
COMPLETED
Last Update Posted:
2019-12-27
First Post:
2009-06-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
An Evaluation of Actigraphy as an Indicator of Sleep and Wake in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-24', 'studyFirstSubmitDate': '2009-06-25', 'studyFirstSubmitQcDate': '2009-06-25', 'lastUpdatePostDateStruct': {'date': '2019-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-06-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['actigraphy', 'polysomnography', 'pediatrics', 'sleep', 'To validate Actigraphy against polysomnography'], 'conditions': ['Sleep Monitoring']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to learn how well an instrument called an Actiwatch-2 can determine whether a child is asleep or awake. The Actiwatch-2 (manufactured by Minimitter/Respironics of Bend, Oregon) is the brand name for an actigraphy monitor; that is, a motion sensor that is typically worn on the wrist and looks like a wrist watch. It measures and records the amount of movement a person makes each minute. After being worn overnight, data are transferred from the Actiwatch to a computer, and a program estimates whether a person is awake or asleep by analyzing the recorded movement data. The enrollment target is 80 participants. Although other actigraphy equipment has been used to monitor sleep in children, the Actiwatch-2 has not been validated in the pediatric population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '6 Months', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'pediatric patients receiving sleep study as part of their standard medical care', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children (ages 6 months to 18 years) who are undergoing a medically necessary sleep study \\[polysomnography (PSG)\\] in the OHSU Sleep Disorders Laboratory\n* ASA classification I and II (children in good health)\n\nExclusion Criteria:\n\n* ASA classification III, IV (children with a chronic or severe disease).\n* Children with developmental delay.\n* Children born extremely prematurely (before 32 weeks gestation), as these children and their parents may react differently to experimental procedures\n* Children who do not speak English or whose parents do not speak English.'}, 'identificationModule': {'nctId': 'NCT00928993', 'briefTitle': 'An Evaluation of Actigraphy as an Indicator of Sleep and Wake in Children', 'organization': {'class': 'OTHER', 'fullName': 'Oregon Health and Science University'}, 'officialTitle': 'An Evaluation of Actigraphy as an Indicator of Sleep and Wake in Children', 'orgStudyIdInfo': {'id': 'IRB00005369'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Main group', 'description': 'pediatric patients receiving overnight sleep study'}]}, 'contactsLocationsModule': {'locations': [{'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Multnomah Pavilion, OHSU', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Kyle Johnson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Health and Science University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Philips Respironics', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}