Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-27 @ 11:59 PM
Study NCT ID:
NCT01276860
Status:
COMPLETED
Last Update Posted:
2021-05-05
First Post:
2011-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Use of Psychomotor Vigilance Testing in the Assessment of Pediatric Obstructive Sleep Apnea
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': 'boswelljl@archildrens.org', 'phone': '501-364-2018', 'title': 'Clinical Research Coordinator', 'organization': "Arkansas Children's Hospital"}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Treatment Group', 'description': 'PVT subjects with sleep complaints.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Group', 'description': 'PVT subjects without sleep complaints.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Who Achieved Criteria of Obstructive Sleep Apnea in the PVT Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group', 'description': 'PVT subjects with sleep complaints/Obstructive Sleep Apnea.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'PVT subjects without sleep complaints.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '10-20 minutes each session, 3 sessions total', 'description': 'Subjects with obstructive sleep apnea will be asked to participate in 3 sessions. Your child will be asked to complete some noninvasive tests at each session. These tests consist of Psychomotor Vigilance Task testing. A Psychomotor Vigilance Task (PVT) will measure your level of alertness and attentiveness. The PVT involves pressing a button after hearing a specific tone or seeing a flashing light. This test takes approximately 10 minutes to complete. The PVT testing will be done at the first clinic visit, then before any treatments, and finally after treatments have taken place. Outcome Measure is full completion of the PVT testing.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis of each participant is based on the timing between hearing a specific tone or seeing a flashing light and the pressing of the button to record the alertness and attentiveness. Finalized analysis is not completed as the study was ended early and data not analyzed to compare groups.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Achieved Criteria of No Sleep Complaints in the PVT Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group', 'description': 'PVT subjects with sleep complaints/Obstructive Sleep Apnea.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'PVT subjects without sleep complaints.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '10-20 minute session, 1 session', 'description': 'Subjects in the control group without clinical signs and symptoms of sleep apnea will only undergo PVT for one session. Your child will be asked to complete some noninvasive tests at this session. These tests consist of Psychomotor Vigilance Task testing. A Psychomotor Vigilance Task (PVT) will measure your level of alertness and attentiveness. The PVT involves pressing a button after hearing a specific tone or seeing a flashing light. This test takes approximately 10 minutes to complete. Outcome Measure is full completion of the PVT testing.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis of each participant is based on the timing between hearing a specific tone or seeing a flashing light and the pressing of the button to record the alertness and attentiveness. Finalized analysis is not completed as the study was ended early and data not analyzed to compare groups.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment Group', 'description': 'PVT subjects with sleep complaints.'}, {'id': 'FG001', 'title': 'Control Group', 'description': 'PVT subjects without sleep complaints.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment Group', 'description': 'PVT subjects with sleep complaints.Control subjects will be asked to participate in one session. Treatment subjects will be asked to participate in 3 sessions.'}, {'id': 'BG001', 'title': 'Control Group', 'description': 'PVT subjects without sleep complaints.Control subjects will be asked to participate in one session. Treatment subjects will be asked to participate in 3 sessions.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '6-18 years', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-03', 'studyFirstSubmitDate': '2011-01-12', 'resultsFirstSubmitDate': '2019-09-03', 'studyFirstSubmitQcDate': '2011-01-12', 'lastUpdatePostDateStruct': {'date': '2021-05-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-05-26', 'studyFirstPostDateStruct': {'date': '2011-01-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Achieved Criteria of Obstructive Sleep Apnea in the PVT Assessment', 'timeFrame': '10-20 minutes each session, 3 sessions total', 'description': 'Subjects with obstructive sleep apnea will be asked to participate in 3 sessions. Your child will be asked to complete some noninvasive tests at each session. These tests consist of Psychomotor Vigilance Task testing. A Psychomotor Vigilance Task (PVT) will measure your level of alertness and attentiveness. The PVT involves pressing a button after hearing a specific tone or seeing a flashing light. This test takes approximately 10 minutes to complete. The PVT testing will be done at the first clinic visit, then before any treatments, and finally after treatments have taken place. Outcome Measure is full completion of the PVT testing.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Who Achieved Criteria of No Sleep Complaints in the PVT Assessment', 'timeFrame': '10-20 minute session, 1 session', 'description': 'Subjects in the control group without clinical signs and symptoms of sleep apnea will only undergo PVT for one session. Your child will be asked to complete some noninvasive tests at this session. These tests consist of Psychomotor Vigilance Task testing. A Psychomotor Vigilance Task (PVT) will measure your level of alertness and attentiveness. The PVT involves pressing a button after hearing a specific tone or seeing a flashing light. This test takes approximately 10 minutes to complete. Outcome Measure is full completion of the PVT testing.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Obstructive Sleep Apnea', 'Pediatric Obstructive Sleep Apnea', 'OSA', 'PVT', 'Psychomotor Vigilance Testing', 'Psychomotor Vigilance Task'], 'conditions': ['Pediatric Obstructive Sleep Apnea']}, 'descriptionModule': {'briefSummary': "Obstructive sleep apnea results in decreased attentiveness and response times in patients. The objective of this study is to quantify these consequences in pediatric OSA patients using an already established tool for examining the results of sleep deprivation and fragmentation: psychomotor vigilance testing. PVT has been used in children, but has not been studied in pediatric OSA patients. This study aims to employ PVT along the normal course of diagnosis and treatment of pediatric OSA patients in our clinical practice at Arkansas Children's Hospital. The investigators hypothesize that pediatric OSA patients will exhibit decreased PVT scoring when compared to children without OSA, and that PVT can be used to diagnose and monitor treatment outcomes in these patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy pediatric patients ages 6-18 years old\n* with symptoms of OSA (snoring, pauses in sleep breathing, restless sleep, frequent arousals, excellive daytime sleepiness, morning headaches)\n* with physical exam findings consistent with adenotonsillar hypertrophy\n* those identified as good candidates for adenotonsillectomy\n* who are to undergo a polysomnogram as part of their preoperative work-up\n\nExclusion Criteria:\n\n* History of attention deficit disorder, developmental delay, or mental retardation\n* Children taking any neurotropic medications (including antiepileptics, antidepressives, and stimulants)\n* Children previously treated for OSA (surgically or medically)\n* Children with significant comorbidities including other sleep-related disorders'}, 'identificationModule': {'nctId': 'NCT01276860', 'acronym': 'PVT', 'briefTitle': 'The Use of Psychomotor Vigilance Testing in the Assessment of Pediatric Obstructive Sleep Apnea', 'organization': {'class': 'OTHER', 'fullName': 'University of Arkansas'}, 'officialTitle': 'The Use of Psychomotor Vigilance Testing in the Assessment of Pediatric Obstructive Sleep Apnea', 'orgStudyIdInfo': {'id': '112316'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Psychomotor Vigilance Testing', 'description': 'The purpose of this study is to examine the use of psychomotor vigilance testing (PVT) as a tool in the diagnosis and prediction of pediatric obstructive sleep apnea. PVT simply involves responding to a light by pressing a button on a small handheld device. It is a simple measure of reaction time.', 'interventionNames': ['Device: Psychomotor Vigilance Testing']}], 'interventions': [{'name': 'Psychomotor Vigilance Testing', 'type': 'DEVICE', 'description': 'The purpose of this study is to examine the use of psychomotor vigilance testing (PVT) as a tool in the diagnosis and prediction of pediatric obstructive sleep apnea. PVT simply involves responding to a light by pressing a button on a small handheld device. It is a simple measure of reaction time.', 'armGroupLabels': ['Psychomotor Vigilance Testing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72202', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': "Arkansas Children's Hospital", 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}], 'overallOfficials': [{'name': 'Gresham T Richter, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UAMS, ACH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Arkansas', 'class': 'OTHER'}, 'collaborators': [{'name': "Arkansas Children's Hospital Research Institute", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}