Ignite Creation Date:
2025-12-25 @ 1:21 AM
Ignite Modification Date:
2025-12-25 @ 11:30 PM
Study NCT ID:
NCT01485393
Status:
COMPLETED
Last Update Posted:
2019-10-08
First Post:
2011-11-30
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Polysomnographic Study Comparing the Use of Dexmedetomidine and Zolpidem to Induce Natural Sleep
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': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D000077334', 'term': 'Zolpidem'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ojohnsonakeju@partners.org', 'phone': '6177247200', 'title': 'Dr. Johnson-Akeju', 'organization': 'MGH'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Insomniac patients were not conducted as originally proposed due to difficult enrollment.\n\nThe Motor Sequence Task was not performed as originally proposed, so it has been removed as a secondary outcome measure.'}}, 'adverseEventsModule': {'timeFrame': 'Through completion of all three study visits (approximately 2 weeks).', 'eventGroups': [{'id': 'EG000', 'title': 'Zolpidem', 'description': 'This arm reflects the night of Zolpidem-induced sleep for all 10 participants.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Dexmedetomidine', 'description': 'This arm reflects the night of Dexmedetomidine-induced sleep for all 10 participants.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Sleep Quality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zolpidem-Induced Sleep', 'description': 'All healthy control subjects undergo a night of zolpidem-induced sleep.'}, {'id': 'OG001', 'title': 'Dexmedetomidine-Induced Sleep', 'description': 'All healthy control subjects undergo a night of dexmedetomidine-induced sleep.'}], 'classes': [{'title': 'Changes in total non-REM sleep', 'categories': [{'measurements': [{'value': '33.2', 'groupId': 'OG000', 'lowerLimit': '4.6', 'upperLimit': '61.7'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Changes in REM sleep', 'categories': [{'measurements': [{'value': '-35', 'groupId': 'OG000', 'lowerLimit': '-60.3', 'upperLimit': '-9.8'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Changes in N3 sleep', 'categories': [{'measurements': [{'value': '35.8', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '68.9'}, {'value': '26.8', 'groupId': 'OG001', 'lowerLimit': '2.2', 'upperLimit': '51.3'}]}]}, {'title': 'Subjective differences in sleep', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Approximately 8 hours', 'description': 'Sleep quality will be assessed objectively through EEG measures (changes from baseline in length of non-REM sleep, length of REM sleep, and length of N3 sleep--all assessed in minutes) and subjectively, utilizing a post sleep questionnaire to assess the difference in quantity of sleep (minutes) from baseline. Sleep quality is directly related to these measures of sleep quantity.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients undergo both zolpidem- and dexmedetomidine-induced sleep. Data analysis for this cohort was performed irrespective of randomization order.'}, {'type': 'SECONDARY', 'title': 'Performance on a Psychomotor Vigilance Test (PVT) After Waking up From Sleep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zolpidem-Induced Sleep', 'description': 'All healthy control subjects undergo a night of zolpidem-induced sleep.'}, {'id': 'OG001', 'title': 'Dexmedetomidine-Induced Sleep', 'description': 'All healthy control subjects undergo a night of Dexmedetomidine-induced sleep.'}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Approximately 30 minutes after waking up', 'description': 'The PVT is a measure of reaction time. It is measured as Lapse 400, which is the number of responses on the PVT greater than 400 milliseconds.', 'unitOfMeasure': 'responses', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients undergo both zolpidem- and dexmedetomidine-induced sleep. Data analysis for this cohort was performed irrespective of randomization order.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Healthy Control Subjects: Zolpidem, Then Dexmedetomidine', 'description': 'This arm will enroll healthy control subjects, who will receive a regular nights sleep followed by a night of Zolpidem induced-sleep and then a night of Dexmedetomidine induced-sleep.'}, {'id': 'FG001', 'title': 'Healthy Control Subjects: Dexmedetomidine, Then Zolpidem', 'description': 'This arm will enroll healthy control subjects, who will receive a regular nights sleep followed by a night of Dexmedetomidine induced-sleep and then a night of Zolpidem induced-sleep.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Participants', 'description': 'All study participants who were either randomized to receive either Dexmedetomidine or Zolpidem initially.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '23.9', 'groupId': 'BG000', 'lowerLimit': '21', 'upperLimit': '29'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-11-09', 'size': 174301, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-08-01T13:49', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Patients will receive both interventions in a randomized order.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2018-06-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-07', 'studyFirstSubmitDate': '2011-11-30', 'resultsFirstSubmitDate': '2019-01-04', 'studyFirstSubmitQcDate': '2011-12-01', 'lastUpdatePostDateStruct': {'date': '2019-10-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-10-07', 'studyFirstPostDateStruct': {'date': '2011-12-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Sleep Quality', 'timeFrame': 'Approximately 8 hours', 'description': 'Sleep quality will be assessed objectively through EEG measures (changes from baseline in length of non-REM sleep, length of REM sleep, and length of N3 sleep--all assessed in minutes) and subjectively, utilizing a post sleep questionnaire to assess the difference in quantity of sleep (minutes) from baseline. Sleep quality is directly related to these measures of sleep quantity.'}], 'secondaryOutcomes': [{'measure': 'Performance on a Psychomotor Vigilance Test (PVT) After Waking up From Sleep', 'timeFrame': 'Approximately 30 minutes after waking up', 'description': 'The PVT is a measure of reaction time. It is measured as Lapse 400, which is the number of responses on the PVT greater than 400 milliseconds.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Insomnia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether dexmedetomidine can be used to induce normal physiological sleep in humans.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary Inclusion Criteria for "Insomniac" subjects:\n\nSubjects will be deemed "Insomniacs" if they suffer from any of the following:\n\n1. Subject will be required to meet the criteria for insomnia, set by the International Classification of Sleep Disorders, which requires that a patient have difficulty initiating or maintaining sleep that is not accounted for by another sleep disorder, neurologic or psychiatric disorder or substance or medication.\n2. Subject will be required to not be on any current pharmacological sleep disorder treatment.\n3. Between the ages of 18 and 35 years.\n4. Not taking any prescription medications that alter sleep, cognitive functions, or both.\n\nExclusion Criteria:\n\nPrimary Exclusion Criteria for "Healthy" control subjects:\n\n1. Abnormal sleep habits:\n\n * sleeping less than 5 hours each night;\n * going to sleep before 9:00 PM or after 2:00 AM on a regular basis; or\n * Waking up before 5:00 AM or after 10:00 AM on a regular basis. This will be objectively assessed by wrist actigraphy measured for a 1-week duration prior to the first study night.\n2. A sleep latency greater than 60 minutes, greater than 3 awakenings per night. This will also be objectively assessed by wrist actigraphy.\n3. A score greater than or equal to 10 on the Epworth Sleepiness Scale.\n4. Takes medication that alters sleep, cognitive function, or both.\n5. Has a history of a known neurological or psychiatric problem.\n6. Younger than 18 or older than 35 years of age.\n7. Known or suspected sleep disorder(s).'}, 'identificationModule': {'nctId': 'NCT01485393', 'briefTitle': 'Polysomnographic Study Comparing the Use of Dexmedetomidine and Zolpidem to Induce Natural Sleep', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Pilot Study Comparing the Use of Dexmedetomidine and Zolpidem to Induce Natural Sleep', 'orgStudyIdInfo': {'id': '2011P-000715'}, 'secondaryIdInfos': [{'id': 'DP1OD003646', 'link': 'https://reporter.nih.gov/quickSearch/DP1OD003646', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healthy Control Subjects: Zolpidem, Then Dexmedetomidine', 'description': 'This arm will enroll healthy control subjects, who will receive a regular nights sleep followed by a night of Zolpidem induced-sleep and then a night of Dexmedetomidine induced-sleep.', 'interventionNames': ['Drug: Dexmedetomidine', 'Drug: Zolpidem']}, {'type': 'EXPERIMENTAL', 'label': 'Healthy Control Subjects: Dexmedetomidine, Then Zolpidem', 'description': 'This arm will enroll healthy control subjects, who will receive a regular nights sleep followed by a night of Dexmedetomidine induced-sleep and then a night of Zolpidem induced-sleep.', 'interventionNames': ['Drug: Dexmedetomidine', 'Drug: Zolpidem']}], 'interventions': [{'name': 'Dexmedetomidine', 'type': 'DRUG', 'otherNames': ['Precedex'], 'description': 'A dose of dexmedetomidine will be administered at 1mcg/kg over 10 minutes. Subjects will never receive active drugs (Zolpidem or dexmedetomidine concurrently).', 'armGroupLabels': ['Healthy Control Subjects: Dexmedetomidine, Then Zolpidem', 'Healthy Control Subjects: Zolpidem, Then Dexmedetomidine']}, {'name': 'Zolpidem', 'type': 'DRUG', 'description': '12.5 mg of oral Ambien CR. Subjects will never receive active drugs (Zolpidem/Ambien or dexmedetomidine concurrently).', 'armGroupLabels': ['Healthy Control Subjects: Dexmedetomidine, Then Zolpidem', 'Healthy Control Subjects: Zolpidem, Then Dexmedetomidine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant in Anesthaesia', 'investigatorFullName': 'Oluwaseun Johnson-Akeju, MD, MMSc', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}