Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2026-02-13 @ 11:37 AM
Study NCT ID:
NCT02818569
Status:
COMPLETED
Last Update Posted:
2019-10-02
First Post:
2016-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Repurposing Dexmedetomidine as an Orally Administered Sleep Therapeutic
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': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ojohnsonakeju@partners.org', 'phone': '617-724-7200', 'title': 'Dr. Oluwaseun Johnson-Akeju', 'organization': 'Massachusetts General Hospital'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Length of study conduction through visits 1-4', 'eventGroups': [{'id': 'EG000', 'title': 'Experimental', 'description': 'Oral Dexmedetomidine\n\nDexmedetomidine: Oral form', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo Comparator', 'description': 'Saline\n\nSaline Placebo: Saline Placebo', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Hemodynamic Stability (Phase I)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Dexmedetomidine', 'description': 'Dexmedetomidine\n\nType: Oral'}, {'id': 'OG001', 'title': 'Placebo Comparator', 'description': 'Placebo Comparator\n\nType: Saline'}], 'classes': [{'title': 'SBP < 60 mmHG', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hypertension', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Bradycardia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Active study night, visit 3 or 4', 'description': 'Number of participants with (1) systolic blood pressure (SBP) \\< 60 mmHg, diastolic blood pressure (DBP) \\< 40 mmHg or decrease of SBP by ≥ 50 % from the baseline which is sustained over two consecutive minutes, (2) hypertension: SBP \\> 180 mmHg, DBP \\> 100 mmHg, or increase of SBP by ≥ 50 % from the baseline which is sustained over two minutes and, (3) bradycardia: heart rate (HR) \\< 40 bpm or decrease by ≥ 50 % from the baseline sustained over two consecutive minutes.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Polysomnography Sleep Quality (Phase II).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Dexmedetomidine', 'description': 'Oral Dexmedetomidine'}, {'id': 'OG001', 'title': 'Placebo Comparator', 'description': 'Saline\n\nSaline Placebo: Saline Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Active study night, visit 3 or 4', 'description': 'Number of participants who had EEG features of natural sleep. Relative quantities of spindles and k-complexes were used to assess approximation to natural sleep.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All 15 Participants completed both arms of the study. After being randomized and completing a single arm, they proceeded to complete the second arm thereafter.'}, {'type': 'SECONDARY', 'title': 'Performance on the Psychomotor Vigilance Task (Phase II)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental', 'description': 'Oral Dexmedetomidine\n\nDexmedetomidine: Oral form'}, {'id': 'OG001', 'title': 'Placebo Comparator', 'description': 'Saline\n\nSaline Placebo: Saline Placebo'}], 'classes': [{'title': 'Training (Before Sleep)', 'categories': [{'measurements': [{'value': '5.8', 'spread': '5', 'groupId': 'OG000'}, {'value': '6.5', 'spread': '7', 'groupId': 'OG001'}]}]}, {'title': 'Testing (After Sleep)', 'categories': [{'measurements': [{'value': '14.5', 'spread': '15.5', 'groupId': 'OG000'}, {'value': '12.3', 'spread': '13.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Active study night, visit 3 or 4', 'description': 'The number of responses that were longer than 400 milliseconds (lapse 400).', 'unitOfMeasure': 'lapses', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Performance on the Motor Sequence Task (Phase II)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental', 'description': 'Oral Dexmedetomidine\n\nDexmedetomidine: Oral form'}, {'id': 'OG001', 'title': 'Placebo Comparator', 'description': 'Saline\n\nSaline Placebo: Saline Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Active study night, visit 3 or 4', 'description': 'Number of participants with improved MST score after sleeping.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Subjective Sleep Quality (Phase II)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental', 'description': 'Oral Dexmedetomidine\n\nDexmedetomidine: Oral form'}, {'id': 'OG001', 'title': 'Placebo Comparator', 'description': 'Saline\n\nSaline Placebo: Saline Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '33', 'spread': '24.4', 'groupId': 'OG000'}, {'value': '36.3', 'spread': '27.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Active study night, visit 3 or 4', 'description': 'Self-reported sleep latency.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Oral Dexmedetomidine, Then Placebo', 'description': "This arm will enroll healthy control subjects, who will have an acclimation night followed by a night's sleep with oral dexmedetomidine and then a night's sleep with a placebo comparator."}, {'id': 'FG001', 'title': 'Placebo, Then Oral Dexmedetomidine', 'description': "This arm will enroll healthy control subjects, who will have an acclimation night followed by a night's sleep with a placebo comparator and then a night's sleep with oral dexmedetomidine."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'All 15 patients were enrolled in both study arms, undergoing sleep with oral dex and a placebo.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'All 15 participants completed both arms (dexmedetomidine and placebo) for the study. After being randomized and completing the first arm, patients completed the alternative arm thereafter.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Participants', 'description': 'All study participants who were either randomized to receive either Oral Dexmedetomidine or the placebo comparator initially.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'All 15 Participants completed both arms of the study. After being randomized and completing a single arm, they proceeded to complete the second arm thereafter.'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'All 15 Participants completed both arms of the study. After being randomized and completing a single arm, they proceeded to complete the second arm thereafter.'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'All 15 Participants completed both arms of the study. After being randomized and completing a single arm, they proceeded to complete the second arm thereafter.'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'All 15 Participants completed both arms of the study. After being randomized and completing a single arm, they proceeded to complete the second arm thereafter.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All 15 Participants completed both arms of the study. After being randomized and completing a single arm, they proceeded to complete the second arm thereafter.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-07-12', 'size': 249822, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-08-01T15:20', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Patients will receive both the oral dexmedetomidine intervention and placebo comparator in a randomized order.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2018-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-01', 'studyFirstSubmitDate': '2016-06-13', 'resultsFirstSubmitDate': '2019-08-15', 'studyFirstSubmitQcDate': '2016-06-27', 'lastUpdatePostDateStruct': {'date': '2019-10-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-10-01', 'studyFirstPostDateStruct': {'date': '2016-06-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-10-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hemodynamic Stability (Phase I)', 'timeFrame': 'Active study night, visit 3 or 4', 'description': 'Number of participants with (1) systolic blood pressure (SBP) \\< 60 mmHg, diastolic blood pressure (DBP) \\< 40 mmHg or decrease of SBP by ≥ 50 % from the baseline which is sustained over two consecutive minutes, (2) hypertension: SBP \\> 180 mmHg, DBP \\> 100 mmHg, or increase of SBP by ≥ 50 % from the baseline which is sustained over two minutes and, (3) bradycardia: heart rate (HR) \\< 40 bpm or decrease by ≥ 50 % from the baseline sustained over two consecutive minutes.'}, {'measure': 'Polysomnography Sleep Quality (Phase II).', 'timeFrame': 'Active study night, visit 3 or 4', 'description': 'Number of participants who had EEG features of natural sleep. Relative quantities of spindles and k-complexes were used to assess approximation to natural sleep.'}], 'secondaryOutcomes': [{'measure': 'Performance on the Psychomotor Vigilance Task (Phase II)', 'timeFrame': 'Active study night, visit 3 or 4', 'description': 'The number of responses that were longer than 400 milliseconds (lapse 400).'}, {'measure': 'Performance on the Motor Sequence Task (Phase II)', 'timeFrame': 'Active study night, visit 3 or 4', 'description': 'Number of participants with improved MST score after sleeping.'}, {'measure': 'Subjective Sleep Quality (Phase II)', 'timeFrame': 'Active study night, visit 3 or 4', 'description': 'Self-reported sleep latency.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Sleep', 'Insomnia']}, 'descriptionModule': {'briefSummary': 'The broad objective of this investigation is to assess the safety and efficacy of oral therapy with dexmedetomidine for the induction and maintenance of restful sleep.', 'detailedDescription': 'Sleep is a basic human function that occupies approximately one-third of our lives. Much of what is known about the benefits of sleep in humans has been obtained from studies of patients with insomnia, the most common sleep disorder with a reported prevalence of 10 to 15%. Unfortunately, insomnia is an independent risk factor for acute myocardial infarction, coronary heart disease, heart failure, hypertension, diabetes, and death. More so, sleep disturbances lead to neurocognitive deficits such as delirium and psychosis. However, the principal medications (i.e. benzodiazepines, zolpidem) currently used to treat insomnia are associated with side effects such as daytime sedation, delirium, anterograde memory disturbance, and complex sleep-related behaviors. We recently found that a nighttime intravenous bolus administration of dexmedetomidine was associated with normal sleep architecture comprising of rapid eye movement (REM) and non-REM (N1, N2, N3) sleep, with improved next-day psychomotor vigilance performance compared to zolpidem. Presently, dexmedetomidine is only available in an intravenous formulation. The goal of this project is to develop dexmedetomidine, an alpha-2 receptor agonist, into an oral sleep therapeutic with a neurocognitive sparing profile.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18-50\n* Native English speaking\n* ASA physical status classification P1 and P2 (stable chronic condition)\n* Normal body habitus.\n\nExclusion Criteria:\n\n* Abnormal sleep habits\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\n* Waking up before 5:00 AM or after 10:00 AM on a regular basis.\n* Takes medication that alters sleep, cognitive function, or both. -Has a history of a known neurological or psychiatric problem.\n* Younger than 18 or older than 50 years of age.\n* Known or suspected sleep disorder(s).'}, 'identificationModule': {'nctId': 'NCT02818569', 'briefTitle': 'Repurposing Dexmedetomidine as an Orally Administered Sleep Therapeutic', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Repurposing Dexmedetomidine as an Orally Administered Sleep Therapeutic', 'orgStudyIdInfo': {'id': '2016P000269'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oral Dexmedetomidine, Then Placebo', 'description': "This arm will enroll healthy control subjects, who will have an acclimation night followed by a night's sleep with oral dexmedetomidine and then a night's sleep with a placebo comparator.", 'interventionNames': ['Drug: Dexmedetomidine', 'Other: Saline Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo, Then Oral Dexmedetomidine', 'description': "This arm will enroll healthy control subjects, who will have an acclimation night followed by a night's sleep with a placebo comparator and then a night's sleep with oral dexmedetomidine .", 'interventionNames': ['Drug: Dexmedetomidine', 'Other: Saline Placebo']}], 'interventions': [{'name': 'Dexmedetomidine', 'type': 'DRUG', 'otherNames': ['Precedex'], 'description': 'Oral form', 'armGroupLabels': ['Oral Dexmedetomidine, Then Placebo', 'Placebo, Then Oral Dexmedetomidine']}, {'name': 'Saline Placebo', 'type': 'OTHER', 'otherNames': ['Saline'], 'description': 'Saline Placebo', 'armGroupLabels': ['Oral Dexmedetomidine, Then Placebo', 'Placebo, Then Oral Dexmedetomidine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'We are undecided.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor in Anesthesia', 'investigatorFullName': 'Oluwaseun Johnson-Akeju, MD, MMSc', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}