Ignite Creation Date:
2025-12-24 @ 1:40 PM
Ignite Modification Date:
2026-01-01 @ 6:52 PM
Study NCT ID:
NCT03165695
Status:
WITHDRAWN
Last Update Posted:
2020-01-22
First Post:
2017-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ramelteon vs Placebo for Prevention of Delirium and Improvement of Sleep in Hospitalized Older Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003693', 'term': 'Delirium'}, {'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C495910', 'term': 'ramelteon'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Never funded', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-01-19', 'studyFirstSubmitDate': '2017-05-22', 'studyFirstSubmitQcDate': '2017-05-23', 'lastUpdatePostDateStruct': {'date': '2020-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of delirium', 'timeFrame': '7 days or less depending on the length of hospital stay', 'description': 'Incidence of delirium measured by DRS-98R'}], 'secondaryOutcomes': [{'measure': 'Severity of delirium', 'timeFrame': '7 days or less depending on the length of hospital stay', 'description': 'Decreased mean DRS-98R score'}, {'measure': 'Sleep improvement', 'timeFrame': '7 days or less depending on the length of hospital stay', 'description': 'Improvement in sleep metrics: increased duration of sleep as measured by Actigraphy'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Delirium', 'Insomnia', 'Ramelteon'], 'conditions': ['Delirium in Old Age']}, 'descriptionModule': {'briefSummary': 'This study evaluates whether Ramelteon can prevent delirium, decrease the severity of incident delirium and improve sleep wake cycle in hospitalized elderly surgical patients. Half of the patients will be assigned to Ramelteon, while other half will be assigned to placebo.', 'detailedDescription': 'Delirium is a common clinical syndrome characterized by acute cognitive dysfunction with core features of inattention, disorganized thinking, perceptual disturbances and sleep-wake cycle disruption. It is typically multifactorial and can be triggered by acute infection, metabolic derangements, surgery, and certain medications. Older adults have a much higher incidence of delirium. Delirium increases in-hospital mortality, length of stay, rate of institutionalization and may cause or exacerbate cognitive impairment. The present pilot study investigates sleep loss as potentially important contributing factors in delirium and an opportunity for intervention. Sleep disruption is prevalent among hospitalized patients. Sufficient sleep is important for recovery from illness, management of pain, wound healing, and a variety of other biologic functions integral to recovery in addition to its putative role in delirium prevention. Melatonin plays an important role in circadian rhythms and sleep-wake cycle regulation. Melatonin secretion is altered in hospitalized older patients in comparison with community-living older individuals. Melatonin and the melatonin-receptor agonist Ramelteon have been studied and have shown promise in delirium prevention, in addition to promoting sleep. We propose to test the use of Ramelteon to decrease delirium and improve sleep/wake cycles in the elderly surgical patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 65 years of age or older.\n* Admitted to BWH vascular surgical service.\n* Able to provide informed consent or a surrogate is available to provide informed consent.\n* Absence of delirium at time of consent.\n\nExclusion Criteria:\n\n* Expected stay or life expectancy less than 48 hours\n* Unable to take medications orally\n* Advanced liver disease (Child-Pugh class B or worse)\n* Active treatment with Fluvoxamine\n* Active treatment with antipsychotic medications, benzodiazepines or other hypnotic agents (i.e. Trazodone, Mirtazapine, Zolpidem, Zaleplon)\n* Known or suspected diagnosis of Lewy body dementia\n* Any dermatological condition that may be aggravated by using a wrist sensor.\n* Known pre-existing sleep disorder other than insomnia.'}, 'identificationModule': {'nctId': 'NCT03165695', 'briefTitle': 'Ramelteon vs Placebo for Prevention of Delirium and Improvement of Sleep in Hospitalized Older Adults', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'Ramelteon vs Placebo for Prevention of Delirium and Improvement of Sleep in Hospitalized Older Adults', 'orgStudyIdInfo': {'id': '2017P000656'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ramelteon Arm', 'description': 'Ramelteon tablet 8 mg orally at 21:00 for 7 days or until discharge whichever comes first.', 'interventionNames': ['Drug: Ramelteon']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Arm', 'description': 'Sugar pill manufactured to mimic Ramelteon 8 mg tablet orally at 21:00 for 7 days or until discharge whichever comes first.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Ramelteon', 'type': 'DRUG', 'otherNames': ['Rozerem'], 'description': 'Ramelteon 8 mg tablet orally at 21:00 for 7 days or until discharge whichever comes first', 'armGroupLabels': ['Ramelteon Arm']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo, 1 tablet orally at 21:00 or until discharge whichever comes first', 'armGroupLabels': ['Placebo Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Elizabeth B Klerman, M.D.,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine, Harvard Medical School', 'investigatorFullName': 'Elizabeth B. Klerman', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}