Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2026-02-25 @ 5:36 AM
Study NCT ID:
NCT03077620
Status:
COMPLETED
Last Update Posted:
2022-05-17
First Post:
2016-10-17
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Sleep Quality and Amyloid-Beta Kinetics
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058225', 'term': 'Plaque, Amyloid'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C551624', 'term': 'suvorexant'}, {'id': 'D000073893', 'term': 'Sugars'}], 'ancestors': [{'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'luceyb@wustl.edu', 'phone': '314-747-3805', 'title': 'Dr. Brendan Lucey', 'organization': 'Washington University in St Louis School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was collected from when the participants were consented into the study until 48 hours after the lumbar catheter was removed (~3 months).', 'eventGroups': [{'id': 'EG000', 'title': 'Poor Sleep Group Control', 'description': 'Participant will receive placebo for two consecutive nights and sleep as normal under the same controlled conditions in a clinical research unit.\n\nPlacebo: Participants will be given a placebo at bedtime for two consecutive nights that they are spending in a research unit.', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 10, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Poor Sleep Group Treatment 1', 'description': '10mg Suvorexant tablet h.s. for two consecutive nights\n\nSuvorexant: Participants will be given a sleep aid (10mg or 20mg suvorexant) at bedtime for two consecutive nights that they are spending in a research unit.', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 10, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Poor Sleep Group Treatment 2', 'description': '20mg Suvorexant tablet h.s. for two consecutive nights\n\nSuvorexant: Participants will be given a sleep aid (10mg or 20mg suvorexant) at bedtime for two consecutive nights that they are spending in a research unit.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 10, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Good Sleep Group', 'description': 'Participant will receive placebo for two consecutive nights and sleep as normal under the same controlled conditions in a clinical research unit.\n\nPlacebo: Participants will be given a placebo at bedtime for two consecutive nights that they are spending in a research unit.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 4, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache requiring blood patch', 'notes': 'Headache requiring blood patch after removal of lumbar catheter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Presyncope with lumbar catheter placement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Back/neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash, swelling, or bruising at lumbar catheter site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ringing in ears', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Difference in Amyloid-beta (Abeta) Concentration in the CSF (Cerebral Spinal Fluid) of Individuals With Poor Sleep Efficiency Compared to Those With Good Sleep Efficiency as Measured by ng/ml', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Poor Sleep Group Control', 'description': 'Participant will receive placebo for two consecutive nights and sleep as normal under the same controlled conditions in a clinical research unit.\n\nPlacebo: Participants will be given a placebo at bedtime for two consecutive nights that they are spending in a research unit.'}, {'id': 'OG001', 'title': 'Good Sleep Group', 'description': 'Participant will receive placebo for two consecutive nights and sleep as normal under the same controlled conditions in a clinical research unit.\n\nPlacebo: Participants will be given a placebo at bedtime for two consecutive nights that they are spending in a research unit.'}], 'classes': [{'title': 'Amyloid-beta-42 concentration at hour 0 (ng/ml)', 'categories': [{'measurements': [{'value': '0.573', 'spread': '0.206', 'groupId': 'OG000'}, {'value': '0.623', 'spread': '0.189', 'groupId': 'OG001'}]}]}, {'title': 'Amyloid-beta-42 concentration at hour 2 (ng/ml)', 'categories': [{'measurements': [{'value': '0.600', 'spread': '0.232', 'groupId': 'OG000'}, {'value': '0.520', 'spread': '0.168', 'groupId': 'OG001'}]}]}, {'title': 'Amyloid-beta-42 concentration at hour 4 (ng/ml)', 'categories': [{'measurements': [{'value': '0.583', 'spread': '0.180', 'groupId': 'OG000'}, {'value': '0.528', 'spread': '0.171', 'groupId': 'OG001'}]}]}, {'title': 'Amyloid-beta-42 concentration at hour 6 (ng/ml)', 'categories': [{'measurements': [{'value': '0.573', 'spread': '0.155', 'groupId': 'OG000'}, {'value': '0.542', 'spread': '0.174', 'groupId': 'OG001'}]}]}, {'title': 'Amyloid-beta-42 concentration at hour 8 (ng/ml)', 'categories': [{'measurements': [{'value': '0.598', 'spread': '0.189', 'groupId': 'OG000'}, {'value': '0.548', 'spread': '0.155', 'groupId': 'OG001'}]}]}, {'title': 'Amyloid-beta-42 concentration at hour 10 (ng/ml)', 'categories': [{'measurements': [{'value': '0.602', 'spread': '0.173', 'groupId': 'OG000'}, {'value': '0.537', 'spread': '0.149', 'groupId': 'OG001'}]}]}, {'title': 'Amyloid-beta-42 concentration at hour 12 (ng/ml)', 'categories': [{'measurements': [{'value': '0.635', 'spread': '0.205', 'groupId': 'OG000'}, {'value': '0.536', 'spread': '0.129', 'groupId': 'OG001'}]}]}, {'title': 'Amyloid-beta-42 concentration at hour 14 (ng/ml)', 'categories': [{'measurements': [{'value': '0.645', 'spread': '0.203', 'groupId': 'OG000'}, {'value': '0.556', 'spread': '0.126', 'groupId': 'OG001'}]}]}, {'title': 'Amyloid-beta-42 concentration at hour 16 (ng/ml)', 'categories': [{'measurements': [{'value': '0.661', 'spread': '0.196', 'groupId': 'OG000'}, {'value': '0.578', 'spread': '0.139', 'groupId': 'OG001'}]}]}, {'title': 'Amyloid-beta-42 concentration at hour 18 (ng/ml)', 'categories': [{'measurements': [{'value': '0.659', 'spread': '0.184', 'groupId': 'OG000'}, {'value': '0.579', 'spread': '0.131', 'groupId': 'OG001'}]}]}, {'title': 'Amyloid-beta-42 concentration at hour 20 (ng/ml)', 'categories': [{'measurements': [{'value': '0.680', 'spread': '0.195', 'groupId': 'OG000'}, {'value': '0.568', 'spread': '0.123', 'groupId': 'OG001'}]}]}, {'title': 'Amyloid-beta-42 concentration at hour 22 (ng/ml)', 'categories': [{'measurements': [{'value': '0.674', 'spread': '0.203', 'groupId': 'OG000'}, {'value': '0.584', 'spread': '0.137', 'groupId': 'OG001'}]}]}, {'title': 'Amyloid-beta-42 concentration at hour 24 (ng/ml)', 'categories': [{'measurements': [{'value': '0.691', 'spread': '0.177', 'groupId': 'OG000'}, {'value': '0.618', 'spread': '0.148', 'groupId': 'OG001'}]}]}, {'title': 'Amyloid-beta-42 concentration at hour 26 (ng/ml)', 'categories': [{'measurements': [{'value': '0.674', 'spread': '0.198', 'groupId': 'OG000'}, {'value': '0.592', 'spread': '0.123', 'groupId': 'OG001'}]}]}, {'title': 'Amyloid-beta-42 concentration at hour 28 (ng/ml)', 'categories': [{'measurements': [{'value': '0.692', 'spread': '0.191', 'groupId': 'OG000'}, {'value': '0.658', 'spread': '0.155', 'groupId': 'OG001'}]}]}, {'title': 'Amyloid-beta-42 concentration at hour 30 (ng/ml)', 'categories': [{'measurements': [{'value': '0.660', 'spread': '0.183', 'groupId': 'OG000'}, {'value': '0.680', 'spread': '0.099', 'groupId': 'OG001'}]}]}, {'title': 'Amyloid-beta-42 concentration at hour 32 (ng/ml)', 'categories': [{'measurements': [{'value': '0.652', 'spread': '0.194', 'groupId': 'OG000'}, {'value': '0.621', 'spread': '0.162', 'groupId': 'OG001'}]}]}, {'title': 'Amyloid-beta-42 concentration at hour 34 (ng/ml)', 'categories': [{'measurements': [{'value': '0.682', 'spread': '0.201', 'groupId': 'OG000'}, {'value': '0.620', 'spread': '0.146', 'groupId': 'OG001'}]}]}, {'title': 'Amyloid-beta-42 concentration at hour 36 (ng/ml)', 'categories': [{'measurements': [{'value': '0.743', 'spread': '0.183', 'groupId': 'OG000'}, {'value': '0.625', 'spread': '0.143', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.119', 'ciLowerLimit': '-0.017', 'ciUpperLimit': '0.256', 'pValueComment': 'Poor sleepers compared to good sleepers with Compound Symmetry covariance structure. Mean difference is poor sleepers minus good sleepers.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.064', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '36 hours of CSF collection', 'description': 'Mean difference in amyloid-beta-42 concentration between individuals with poor sleep efficiency (Poor sleep group control) compared to those with good sleep efficiency (Good sleep group)', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Difference in Amyloid-beta (Abeta) Concentration in the CSF (Cerebral Spinal Fluid) of Individuals With Poor Sleep Efficiency Treated With Placebo, Suvorexant 10 mg, or Suvorexant 20 mg as Measured by ng/ml', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Poor Sleep Group Control', 'description': 'Participant will receive placebo for two consecutive nights and sleep as normal under the same controlled conditions in a clinical research unit.\n\nPlacebo: Participants will be given a placebo at bedtime for two consecutive nights that they are spending in a research unit.'}, {'id': 'OG001', 'title': 'Poor Sleep Group Treatment 1', 'description': '10mg Suvorexant tablet h.s. for two consecutive nights\n\nSuvorexant: Participants will be given a sleep aid (10mg or 20mg suvorexant) at bedtime for two consecutive nights that they are spending in a research unit.'}, {'id': 'OG002', 'title': 'Poor Sleep Group Treatment 2', 'description': '20mg Suvorexant tablet h.s. for two consecutive nights\n\nSuvorexant: Participants will be given a sleep aid (10mg or 20mg suvorexant) at bedtime for two consecutive nights that they are spending in a research unit.'}], 'classes': [{'title': 'Amyloid-beta-42 concentration at hour 0 (ng/ml)', 'categories': [{'measurements': [{'value': '0.573', 'spread': '0.206', 'groupId': 'OG000'}, {'value': '0.519', 'spread': '0.171', 'groupId': 'OG001'}, {'value': '0.648', 'spread': '0.146', 'groupId': 'OG002'}]}]}, {'title': 'Amyloid-beta-42 concentration at hour 2 (ng/ml)', 'categories': [{'measurements': [{'value': '0.600', 'spread': '0.232', 'groupId': 'OG000'}, {'value': '0.520', 'spread': '0.182', 'groupId': 'OG001'}, {'value': '0.648', 'spread': '0.129', 'groupId': 'OG002'}]}]}, {'title': 'Amyloid-beta-42 concentration at hour 4 (ng/ml)', 'categories': [{'measurements': [{'value': '0.583', 'spread': '0.180', 'groupId': 'OG000'}, {'value': '0.536', 'spread': '0.205', 'groupId': 'OG001'}, {'value': '0.679', 'spread': '0.129', 'groupId': 'OG002'}]}]}, {'title': 'Amyloid-beta-42 concentration at hour 6 (ng/ml)', 'categories': [{'measurements': [{'value': '0.573', 'spread': '0.155', 'groupId': 'OG000'}, {'value': '0.544', 'spread': '0.207', 'groupId': 'OG001'}, {'value': '0.678', 'spread': '0.139', 'groupId': 'OG002'}]}]}, {'title': 'Amyloid-beta-42 concentration at hour 8 (ng/ml)', 'categories': [{'measurements': [{'value': '0.598', 'spread': '0.189', 'groupId': 'OG000'}, {'value': '0.546', 'spread': '0.217', 'groupId': 'OG001'}, {'value': '0.670', 'spread': '0.122', 'groupId': 'OG002'}]}]}, {'title': 'Amyloid-beta-42 concentration at hour 10 (ng/ml)', 'categories': [{'measurements': [{'value': '0.602', 'spread': '0.173', 'groupId': 'OG000'}, {'value': '0.544', 'spread': '0.222', 'groupId': 'OG001'}, {'value': '0.679', 'spread': '0.124', 'groupId': 'OG002'}]}]}, {'title': 'Amyloid-beta-42 concentration at hour 12 (ng/ml)', 'categories': [{'measurements': [{'value': '0.635', 'spread': '0.205', 'groupId': 'OG000'}, {'value': '0.558', 'spread': '0.222', 'groupId': 'OG001'}, {'value': '0.660', 'spread': '0.121', 'groupId': 'OG002'}]}]}, {'title': 'Amyloid-beta-42 concentration at hour 14 (ng/ml)', 'categories': [{'measurements': [{'value': '0.645', 'spread': '0.203', 'groupId': 'OG000'}, {'value': '0.583', 'spread': '0.223', 'groupId': 'OG001'}, {'value': '0.679', 'spread': '0.111', 'groupId': 'OG002'}]}]}, {'title': 'Amyloid-beta-42 concentration at hour 16 (ng/ml)', 'categories': [{'measurements': [{'value': '0.661', 'spread': '0.196', 'groupId': 'OG000'}, {'value': '0.619', 'spread': '0.233', 'groupId': 'OG001'}, {'value': '0.685', 'spread': '0.120', 'groupId': 'OG002'}]}]}, {'title': 'Amyloid-beta-42 concentration at hour 18 (ng/ml)', 'categories': [{'measurements': [{'value': '0.659', 'spread': '0.184', 'groupId': 'OG000'}, {'value': '0.614', 'spread': '0.205', 'groupId': 'OG001'}, {'value': '0.697', 'spread': '0.140', 'groupId': 'OG002'}]}]}, {'title': 'Amyloid-beta-42 concentration at hour 20 (ng/ml)', 'categories': [{'measurements': [{'value': '0.680', 'spread': '0.195', 'groupId': 'OG000'}, {'value': '0.615', 'spread': '0.197', 'groupId': 'OG001'}, {'value': '0.707', 'spread': '0.139', 'groupId': 'OG002'}]}]}, {'title': 'Amyloid-beta-42 concentration at hour 22 (ng/ml)', 'categories': [{'measurements': [{'value': '0.674', 'spread': '0.203', 'groupId': 'OG000'}, {'value': '0.631', 'spread': '0.199', 'groupId': 'OG001'}, {'value': '0.776', 'spread': '0.161', 'groupId': 'OG002'}]}]}, {'title': 'Amyloid-beta-42 concentration at hour 24 (ng/ml)', 'categories': [{'measurements': [{'value': '0.691', 'spread': '0.177', 'groupId': 'OG000'}, {'value': '0.646', 'spread': '0.198', 'groupId': 'OG001'}, {'value': '0.738', 'spread': '0.158', 'groupId': 'OG002'}]}]}, {'title': 'Amyloid-beta-42 concentration at hour 26 (ng/ml)', 'categories': [{'measurements': [{'value': '0.674', 'spread': '0.198', 'groupId': 'OG000'}, {'value': '0.653', 'spread': '0.193', 'groupId': 'OG001'}, {'value': '0.737', 'spread': '0.169', 'groupId': 'OG002'}]}]}, {'title': 'Amyloid-beta-42 concentration at hour 28 (ng/ml)', 'categories': [{'measurements': [{'value': '0.692', 'spread': '0.191', 'groupId': 'OG000'}, {'value': '0.652', 'spread': '0.191', 'groupId': 'OG001'}, {'value': '0.759', 'spread': '0.166', 'groupId': 'OG002'}]}]}, {'title': 'Amyloid-beta-42 concentration at hour 30 (ng/ml)', 'categories': [{'measurements': [{'value': '0.660', 'spread': '0.183', 'groupId': 'OG000'}, {'value': '0.631', 'spread': '0.189', 'groupId': 'OG001'}, {'value': '0.707', 'spread': '0.125', 'groupId': 'OG002'}]}]}, {'title': 'Amyloid-beta-42 concentration at hour 32 (ng/ml)', 'categories': [{'measurements': [{'value': '0.652', 'spread': '0.194', 'groupId': 'OG000'}, {'value': '0.627', 'spread': '0.215', 'groupId': 'OG001'}, {'value': '0.726', 'spread': '0.16', 'groupId': 'OG002'}]}]}, {'title': 'Amyloid-beta-42 concentration at hour 34 (ng/ml)', 'categories': [{'measurements': [{'value': '0.682', 'spread': '0.201', 'groupId': 'OG000'}, {'value': '0.627', 'spread': '0.226', 'groupId': 'OG001'}, {'value': '0.714', 'spread': '0.159', 'groupId': 'OG002'}]}]}, {'title': 'Amyloid-beta-42 concentration at hour 36 (ng/ml)', 'categories': [{'measurements': [{'value': '0.743', 'spread': '0.183', 'groupId': 'OG000'}, {'value': '0.624', 'spread': '0.217', 'groupId': 'OG001'}, {'value': '0.724', 'spread': '0.126', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.004', 'ciLowerLimit': '-0.078', 'ciUpperLimit': '0.087', 'pValueComment': 'After corrected for multiple comparisons with Bonferroni test, treatment groups 1 and 2 compared to placebo with Compound Symmetry covariance structure. Mean difference is placebo minus treatment group.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.033', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.05', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.033', 'ciLowerLimit': '-0.051', 'ciUpperLimit': '0.117', 'pValueComment': 'After corrected for multiple comparisons with Bonferroni test, treatment groups 1 and 2 compared to placebo with Compound Symmetry covariance structure. Mean difference is placebo minus treatment group.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.033', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '36 hours of CSF collection', 'description': 'Mean difference in amyloid-beta-42 concentration between individuals with poor sleep efficiency who were treated with placebo (Poor sleep group control), Suvorexant 10 mg (Poor sleep group treatment 1), and Suvorexant 20 mg (Poor sleep group treatment 2)', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Poor Sleep Group Control', 'description': 'Participant will receive placebo for two consecutive nights and sleep as normal under the same controlled conditions in a clinical research unit.\n\nPlacebo: Participants will be given a placebo at bedtime for two consecutive nights that they are spending in a research unit.'}, {'id': 'FG001', 'title': 'Poor Sleep Group Treatment 1', 'description': '10mg Suvorexant tablet h.s. for two consecutive nights\n\nSuvorexant: Participants will be given a sleep aid (10mg or 20mg suvorexant) at bedtime for two consecutive nights that they are spending in a research unit.'}, {'id': 'FG002', 'title': 'Poor Sleep Group Treatment 2', 'description': '20mg Suvorexant tablet h.s. for two consecutive nights\n\nSuvorexant: Participants will be given a sleep aid (10mg or 20mg suvorexant) at bedtime for two consecutive nights that they are spending in a research unit.'}, {'id': 'FG003', 'title': 'Good Sleep Group', 'description': 'Participant will receive placebo for two consecutive nights and sleep as normal under the same controlled conditions in a clinical research unit.\n\nPlacebo: Participants will be given a placebo at bedtime for two consecutive nights that they are spending in a research unit.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Unable to place lumbar catheter', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '43', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Poor Sleep Group Control', 'description': 'Participant will receive placebo for two consecutive nights and sleep as normal under the same controlled conditions in a clinical research unit.\n\nPlacebo: Participants will be given a placebo at bedtime for two consecutive nights that they are spending in a research unit.'}, {'id': 'BG001', 'title': 'Poor Sleep Group Treatment 1', 'description': '10mg Suvorexant tablet h.s. for two consecutive nights\n\nSuvorexant: Participants will be given a sleep aid (10mg or 20mg suvorexant) at bedtime for two consecutive nights that they are spending in a research unit.'}, {'id': 'BG002', 'title': 'Poor Sleep Group Treatment 2', 'description': '20mg Suvorexant tablet h.s. for two consecutive nights\n\nSuvorexant: Participants will be given a sleep aid (10mg or 20mg suvorexant) at bedtime for two consecutive nights that they are spending in a research unit.'}, {'id': 'BG003', 'title': 'Good Sleep Group', 'description': 'Participant will receive placebo for two consecutive nights and sleep as normal under the same controlled conditions in a clinical research unit.\n\nPlacebo: Participants will be given a placebo at bedtime for two consecutive nights that they are spending in a research unit.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '43', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.94', 'spread': '6.1', 'groupId': 'BG000'}, {'value': '56.95', 'spread': '4.35', 'groupId': 'BG001'}, {'value': '54.30', 'spread': '5.66', 'groupId': 'BG002'}, {'value': '59.18', 'spread': '7.24', 'groupId': 'BG003'}, {'value': '56.23', 'spread': '5.69', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '31', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}]}]}], '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'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '35', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '43', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'There was a 6th participant in the Good sleep group that had a lumbar catheter placed. However, minimal CSF was collected at a majority of the timepoints. There was insufficient samples of CSF collected to measure amyloid-beta (minimum volume needed was 0.5 ml at each timepoint). The participant agreed to continue the study for collection of blood and to try and continue collecting CSF, but would not agree to replacing the lumbar catheter.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-03-03', 'size': 382163, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-03-28T19:18', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-16', 'studyFirstSubmitDate': '2016-10-17', 'resultsFirstSubmitDate': '2022-03-29', 'studyFirstSubmitQcDate': '2017-03-06', 'lastUpdatePostDateStruct': {'date': '2022-05-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-05-16', 'studyFirstPostDateStruct': {'date': '2017-03-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in Amyloid-beta (Abeta) Concentration in the CSF (Cerebral Spinal Fluid) of Individuals With Poor Sleep Efficiency Compared to Those With Good Sleep Efficiency as Measured by ng/ml', 'timeFrame': '36 hours of CSF collection', 'description': 'Mean difference in amyloid-beta-42 concentration between individuals with poor sleep efficiency (Poor sleep group control) compared to those with good sleep efficiency (Good sleep group)'}, {'measure': 'Difference in Amyloid-beta (Abeta) Concentration in the CSF (Cerebral Spinal Fluid) of Individuals With Poor Sleep Efficiency Treated With Placebo, Suvorexant 10 mg, or Suvorexant 20 mg as Measured by ng/ml', 'timeFrame': '36 hours of CSF collection', 'description': 'Mean difference in amyloid-beta-42 concentration between individuals with poor sleep efficiency who were treated with placebo (Poor sleep group control), Suvorexant 10 mg (Poor sleep group treatment 1), and Suvorexant 20 mg (Poor sleep group treatment 2)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Amyloid-beta']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to change the concentration of amyloid-beta in human cerebrospinal fluid (CSF) by modification of sleep efficiency.', 'detailedDescription': 'The purpose of the study is to investigate whether or not increasing sleep efficiency will change the concentration of amyloid-beta in cerebrospinal fluid (CSF).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 45-65 years\n* Any sex\n* Any race/ethnicity\n* Mini-Mental Status Examination score (MMSE) \\>=27\n* Sleep efficiency measured by actigraphy to determine good sleeper or poor sleeper\n\nExclusion Criteria:\n\n* Cognitive impairment as determined by history of MMSE \\< 27\n* Inability to speak or understand English\n* BMI \\>35\n* Any sleep disorders other than insomnia\n* history of sleep-disordered breathing\n* STOP-Bang score \\> 3\n* History or reported symptoms suggestive of restless legs syndrome, narcolepsy or other sleep disorders\n* Sleep schedule outside the range of bedtime 8PM-12AM and wake time 4AM-9AM\n* Contraindication to lumbar catheter (anticoagulants; bleeding disorder; allergy to lidocaine or disinfectant; prior central nervous system or lower back surgery)\n* Cardiovascular disease requiring medication except for controlled hypertension (PI discretion)\n* Stroke\n* Hepatic or renal impairment\n* Pulmonary disease (PI discretion)\n* Type 1 diabetes\n* HIV or AIDS\n* Neurologic or psychiatric disorder requiring medication (PI discretion)\n* Alcohol or tobacco use (PI discretion)\n* Use of sedating medications\n* Inability to get out of bed independently\n* Abnormal movement of the non-dominant arm (would affect actigraphy data in unpredictable ways)\n* Abnormal physical examination\n* Current pregnancy\n* History of migraine headaches (PI discretion)\n* History of drug abuse in the past 6 months\n* Urinary or fecal incontinence\n* Difficulty sleeping in an unfamiliar environment (good sleep quality group only)\n* History or presence of any clinically significant medication condition, behavioral or psychiatric condition (including suicidal ideation), or surgical history based on medical record or patient report that could affect the safety of the subject or interfere with study assessments or in the judgment of the PI is not a good candidate'}, 'identificationModule': {'nctId': 'NCT03077620', 'briefTitle': 'Sleep Quality and Amyloid-Beta Kinetics', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Sleep Quality and Amyloid-Beta Kinetics', 'orgStudyIdInfo': {'id': '201602165'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Poor sleep group treatment 1', 'description': '10mg Suvorexant tablet h.s. for two consecutive nights', 'interventionNames': ['Drug: Suvorexant']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Poor sleep group control', 'description': 'Participant will receive placebo for two consecutive nights and sleep as normal under the same controlled conditions in a clinical research unit.', 'interventionNames': ['Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Good sleep group', 'description': 'Participant will receive placebo for two consecutive nights and sleep as normal under the same controlled conditions in a clinical research unit.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Poor sleep group treatment 2', 'description': '20mg Suvorexant tablet h.s. for two consecutive nights', 'interventionNames': ['Drug: Suvorexant']}], 'interventions': [{'name': 'Suvorexant', 'type': 'DRUG', 'otherNames': ['Belsomra'], 'description': 'Participants will be given a sleep aid (10mg or 20mg suvorexant) at bedtime for two consecutive nights that they are spending in a research unit.', 'armGroupLabels': ['Poor sleep group treatment 1', 'Poor sleep group treatment 2']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['sugar pill'], 'description': 'Participants will be given a placebo at bedtime for two consecutive nights that they are spending in a research unit.', 'armGroupLabels': ['Good sleep group', 'Poor sleep group control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63144', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Brendan Lucey, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University Medical School'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}