Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2026-03-02 @ 5:52 PM
Study NCT ID:
NCT04024020
Status:
COMPLETED
Last Update Posted:
2025-01-23
First Post:
2019-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Chronic Insomnia and CSF Markers of Dementia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], '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': 'D013129', 'term': 'Spinal Puncture'}], 'ancestors': [{'id': 'D001706', 'term': 'Biopsy'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003943', 'term': 'Diagnostic Techniques, Neurological'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'philip.gehrman@pennmedicine.upenn.edu', 'phone': '2157463578', 'title': 'Philip Gehrman', 'organization': 'University of Pennsylvania'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'The participants in this study had relatively mild insomnia, so it is not known whether the same pattern would be found for more severe cases. The size of this study is also relatively small so larger studies are needed to have more conclusive results.'}}, 'adverseEventsModule': {'timeFrame': 'up to 1 month', 'eventGroups': [{'id': 'EG000', 'title': 'Individuals With Insomnia', 'description': 'Men and women with chronic insomnia (\\>5 years duration)\n\nlumbar puncture: Subjects will have a lumbar puncture to collect cerebrospinal fluid collection', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Good Sleepers', 'description': 'Men and women with a longstanding pattern of good sleep\n\nlumbar puncture: Subjects will have a lumbar puncture to collect cerebrospinal fluid collection', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 1, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'CSF Markers Related to Dementia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Individuals With Insomnia', 'description': 'Men and women with chronic insomnia (\\>5 years duration)\n\nlumbar puncture: Subjects will have a lumbar puncture to collect cerebrospinal fluid collection'}, {'id': 'OG001', 'title': 'Good Sleepers', 'description': 'Men and women with a longstanding pattern of good sleep\n\nlumbar puncture: Subjects will have a lumbar puncture to collect cerebrospinal fluid collection'}], 'classes': [{'title': 'Abeta40', 'categories': [{'measurements': [{'value': '4332.1', 'spread': '1250.5', 'groupId': 'OG000'}, {'value': '4824.0', 'spread': '2336.0', 'groupId': 'OG001'}]}]}, {'title': 'Abeta42', 'categories': [{'measurements': [{'value': '393.2', 'spread': '122.8', 'groupId': 'OG000'}, {'value': '419.4', 'spread': '201.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'one morning', 'description': 'CSF levels of the proteins Abeta40 and Abeta42', 'unitOfMeasure': 'picograms per milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'CSF Levels of Orexin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Individuals With Insomnia', 'description': 'Men and women with chronic insomnia (\\>5 years duration)\n\nlumbar puncture: Subjects will have a lumbar puncture to collect cerebrospinal fluid collection'}, {'id': 'OG001', 'title': 'Good Sleepers', 'description': 'Men and women with a longstanding pattern of good sleep\n\nlumbar puncture: Subjects will have a lumbar puncture to collect cerebrospinal fluid collection'}], 'classes': [{'categories': [{'measurements': [{'value': '215.5', 'spread': '11.9', 'groupId': 'OG000'}, {'value': '214.5', 'spread': '28.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'one morning', 'description': 'Orexin is a chemical in the brain related to sleep regulation', 'unitOfMeasure': 'picograms per milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Individuals With Insomnia', 'description': 'Men and women with chronic insomnia (\\>5 years duration)\n\nlumbar puncture: Subjects will have a lumbar puncture to collect cerebrospinal fluid collection'}, {'id': 'FG001', 'title': 'Good Sleepers', 'description': 'Men and women with a longstanding pattern of good sleep\n\nlumbar puncture: Subjects will have a lumbar puncture to collect cerebrospinal fluid collection'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Individuals With Insomnia', 'description': 'Men and women with chronic insomnia (\\>5 years duration)\n\nlumbar puncture: Subjects will have a lumbar puncture to collect cerebrospinal fluid collection'}, {'id': 'BG001', 'title': 'Good Sleepers', 'description': 'Men and women with a longstanding pattern of good sleep\n\nlumbar puncture: Subjects will have a lumbar puncture to collect cerebrospinal fluid collection'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.0', 'spread': '9.1', 'groupId': 'BG000'}, {'value': '43.2', 'spread': '9.2', 'groupId': 'BG001'}, {'value': '43.1', 'spread': '9.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Insomnia Severity Index', 'classes': [{'categories': [{'measurements': [{'value': '16.5', 'spread': '4.3', 'groupId': 'BG000'}, {'value': '3.6', 'spread': '3.7', 'groupId': 'BG001'}, {'value': '10.1', 'spread': '4.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'This scale provides a measure of overall severity of insomnia, with higher scores indicating more severe symptoms. Scores range from 0 to 28.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-11-15', 'size': 686852, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-12-09T14:58', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-16', 'studyFirstSubmitDate': '2019-07-15', 'resultsFirstSubmitDate': '2024-10-14', 'studyFirstSubmitQcDate': '2019-07-15', 'lastUpdatePostDateStruct': {'date': '2025-01-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-12-16', 'studyFirstPostDateStruct': {'date': '2019-07-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CSF Markers Related to Dementia', 'timeFrame': 'one morning', 'description': 'CSF levels of the proteins Abeta40 and Abeta42'}], 'secondaryOutcomes': [{'measure': 'CSF Levels of Orexin', 'timeFrame': 'one morning', 'description': 'Orexin is a chemical in the brain related to sleep regulation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Insomnia Chronic']}, 'descriptionModule': {'briefSummary': 'The longstanding view has been that insomnia, and other forms of sleep disturbance, emerge as a consequence of dementia and are the result of progressive neuronal damage. However, there is growing evidence that the direction of causation may go both ways, with sleep disturbance potentially increasing vulnerability to dementia. Longitudinal studies have found that sleep disturbance often precedes and increases risk for dementia by several years.The purpose of this study is to examine the relationship between chronic insomnia and dementia biomarkers and orexin levels found in cerebrospinal fluid (CSF). Fifteen adults age 30-50 with chronic insomnia and age- and gender-matched good sleepers will undergo overnight polysomnography and CSF sampling in the morning.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '30 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adults with chronic insomnia and matched good sleepers', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 30-50\n* Men and women\n* To be included in the insomnia group, subjects must meet the following DSM5 Diagnostic Criteria for insomnia disorder: dissatisfaction with sleep quantity or quality (difficulty initiating or maintaining sleep, or waking up too early) despite adequate opportunity for sleep; sleep disturbance causes clinical significant distress or impairment in functioning; present at least 3 times per week for at least 3 months; sleep disturbance is not better explained by a medical or psychiatric condition or based on the effects of a substance\n\nExclusion Criteria:\n\n* Diagnosis or evidence of sleep disorders other than insomnia as determined by the screening questionnaires and clinical history\n* Women who have been pregnant or lactating within the past six months\n* Non-fluency in spoken or written English\n* Current or past month shiftwork defined as working during the evening or night shift\n* Current use of medications or OTC products that impact sleep\n* Evidence of neurological abnormalities that could include the risks associated with lumbar puncture (e.g.papilledema, mass lesion, Chiari malformation).'}, 'identificationModule': {'nctId': 'NCT04024020', 'briefTitle': 'Chronic Insomnia and CSF Markers of Dementia', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Chronic Insomnia and CSF Markers of Dementia', 'orgStudyIdInfo': {'id': '829221'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Individuals with insomnia', 'description': 'Men and women with chronic insomnia (\\>5 years duration)', 'interventionNames': ['Other: lumbar puncture']}, {'label': 'Good sleepers', 'description': 'Men and women with a longstanding pattern of good sleep', 'interventionNames': ['Other: lumbar puncture']}], 'interventions': [{'name': 'lumbar puncture', 'type': 'OTHER', 'description': 'Subjects will have a lumbar puncture to collect cerebrospinal fluid collection', 'armGroupLabels': ['Good sleepers', 'Individuals with insomnia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Philip Gehrman, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}