Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-31 @ 11:57 AM
Study NCT ID:
NCT02884505
Status:
COMPLETED
Last Update Posted:
2019-08-22
First Post:
2016-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving the Assessment of Hypersomnolence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006970', 'term': 'Disorders of Excessive Somnolence'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005072', 'term': 'Evoked Potentials, Auditory'}], 'ancestors': [{'id': 'D005071', 'term': 'Evoked Potentials'}, {'id': 'D000071080', 'term': 'Cortical Excitability'}, {'id': 'D055724', 'term': 'Electrophysiological Phenomena'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D000084323', 'term': 'Vestibulocochlear Physiological Phenomena'}, {'id': 'D009424', 'term': 'Nervous System Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 132}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-20', 'studyFirstSubmitDate': '2016-08-16', 'studyFirstSubmitQcDate': '2016-08-25', 'lastUpdatePostDateStruct': {'date': '2019-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Patients Categorized with Hypersomnolence', 'timeFrame': '2 Years', 'description': 'Multiple measurements will be aggregated to arrive at the primary outcome of proportion of patients categorized as having hypersomnolence using either standard assessments or standard assessments plus additional novel hypersomnolence measures of pupillometry, psychomotor vigilance task, and auditory evoked potentials. Proportion of patients with hypersomnolence using standard measures will be calculated as number of patients with mean sleep latency (MSL) on multiple sleep latency test (MSLT) \\<8 minutes divided by total number of patients. Proportion of patients categorized as having hypersomnolence with additional novel hypersomnolence measures will be calculated as the number of patients with MSL\\<8 minutes, and/or pupillary unrest index (PUI) \\>8.9 on pupillometry, and/or PVT lapses \\>3, and/or P300 delay/sleep negativity during auditory evoked potentials divided by total number of patients.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Disorders of Excessive Somnolence']}, 'descriptionModule': {'briefSummary': 'The overall purpose of this study is to employ a pragmatic, multidimensional assessment of hypersomnolence that "piggybacks" on routine clinical care in patients with suspected disorders of central nervous system (CNS) hypersomnia, to determine whether these additional objective and subjective assessments are useful in the diagnosis and management of these patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients referred for polysomnography and multiple sleep latency test at the University of Wisconsin-Madison', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-89\n* Referred for polysomnography/multiple sleep latency test at Wisconsin Sleep, the sleep medicine clinic and laboratory of the University of Wisconsin-Madison\n\nExclusion Criteria:\n\n* unstable medical condition that, in the opinion of the investigators, would make it unsafe for the subject to participate'}, 'identificationModule': {'nctId': 'NCT02884505', 'briefTitle': 'Improving the Assessment of Hypersomnolence', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'Improving the Assessment of Hypersomnolence', 'orgStudyIdInfo': {'id': '2015-1462'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with Hypersomnolence', 'description': 'Patients referred for polysomnography and multiple sleep latency test', 'interventionNames': ['Device: Pupillometry', 'Behavioral: Psychomotor Vigilance Task', 'Other: Auditory Evoked Potential', 'Behavioral: Hypersomnia Severity Index']}], 'interventions': [{'name': 'Pupillometry', 'type': 'DEVICE', 'description': 'Measures pupillary dynamics in darkness and light conditions', 'armGroupLabels': ['Patients with Hypersomnolence']}, {'name': 'Psychomotor Vigilance Task', 'type': 'BEHAVIORAL', 'description': 'Response time task measuring neurobehavioral alertness', 'armGroupLabels': ['Patients with Hypersomnolence']}, {'name': 'Auditory Evoked Potential', 'type': 'OTHER', 'description': 'Measure of electroencephalographic response to standardized auditory tones', 'armGroupLabels': ['Patients with Hypersomnolence']}, {'name': 'Hypersomnia Severity Index', 'type': 'BEHAVIORAL', 'description': 'Self-report measure of hypersomnolence', 'armGroupLabels': ['Patients with Hypersomnolence']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53719', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin-Madison, Department of Psychiatry', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'David T Plante, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin, Madison'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}