Ignite Creation Date:
2025-12-25 @ 4:41 AM
Ignite Modification Date:
2026-02-22 @ 6:46 PM
Study NCT ID:
NCT03066518
Status:
COMPLETED
Last Update Posted:
2017-02-28
First Post:
2017-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Melatonin on Sleep Quality in Patients Dementia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D003704', 'term': 'Dementia'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008550', 'term': 'Melatonin'}, {'id': 'C005589', 'term': 'pyrithyldione'}], 'ancestors': [{'id': 'D014363', 'term': 'Tryptamines'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Selection for a treatment group was determined by a computer-generated randomization list, in a 1:1 ratio using the randomized permuted blocks method.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A randomized, double-blinded, placebo-controlled study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2017-01-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-23', 'studyFirstSubmitDate': '2017-02-19', 'studyFirstSubmitQcDate': '2017-02-23', 'lastUpdatePostDateStruct': {'date': '2017-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pittsburgh Sleep Quality Index', 'timeFrame': '8 weeks', 'description': 'A self-administered questionnaire that provides an overall rating of sleep quality.'}], 'secondaryOutcomes': [{'measure': 'Minimental test', 'timeFrame': 'baseline and to the 8 weeks', 'description': 'The original purpose is to allow physicians to standardize and quantify cognitive status.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['melatonin', 'sleep', 'dementia', 'cognition'], 'conditions': ['Sleep Disorders', 'Dementia']}, 'referencesModule': {'references': [{'pmid': '21225347', 'type': 'BACKGROUND', 'citation': 'Crowley K. Sleep and sleep disorders in older adults. Neuropsychol Rev. 2011 Mar;21(1):41-53. doi: 10.1007/s11065-010-9154-6. Epub 2011 Jan 12.'}, {'pmid': '19738366', 'type': 'BACKGROUND', 'citation': 'Neikrug AB, Ancoli-Israel S. Sleep disorders in the older adult - a mini-review. Gerontology. 2010;56(2):181-9. doi: 10.1159/000236900. Epub 2009 Sep 9.'}, {'pmid': '19426575', 'type': 'BACKGROUND', 'citation': 'Beaulieu-Bonneau S, Hudon C. Sleep disturbances in older adults with mild cognitive impairment. Int Psychogeriatr. 2009 Aug;21(4):654-66. doi: 10.1017/S1041610209009120. Epub 2009 May 11.'}, {'pmid': '21417189', 'type': 'BACKGROUND', 'citation': 'Woods DL, Phillips LR, Martin JL. Biological basis for sleep disturbance and behavioral symptoms in dementia: a biobehavioral model. Res Gerontol Nurs. 2011 Oct;4(4):281-93. doi: 10.3928/19404921-20110302-01. Epub 2011 Mar 16.'}, {'pmid': '26742676', 'type': 'BACKGROUND', 'citation': 'Guarnieri B, Cerroni G, Sorbi S. Sleep disturbances and cognitive decline: recommendations on clinical assessment and the management. Arch Ital Biol. 2015 Jun-Sep;153(2-3):225-30. doi: 10.12871/0003982920152347.'}, {'pmid': '27476067', 'type': 'BACKGROUND', 'citation': 'Ooms S, Ju YE. Treatment of Sleep Disorders in Dementia. Curr Treat Options Neurol. 2016 Sep;18(9):40. doi: 10.1007/s11940-016-0424-3.'}, {'pmid': '25614508', 'type': 'BACKGROUND', 'citation': 'Xu J, Wang LL, Dammer EB, Li CB, Xu G, Chen SD, Wang G. Melatonin for sleep disorders and cognition in dementia: a meta-analysis of randomized controlled trials. Am J Alzheimers Dis Other Demen. 2015 Aug;30(5):439-47. doi: 10.1177/1533317514568005.'}, {'pmid': '27851868', 'type': 'BACKGROUND', 'citation': 'McCleery J, Cohen DA, Sharpley AL. Pharmacotherapies for sleep disturbances in dementia. Cochrane Database Syst Rev. 2016 Nov 16;11(11):CD009178. doi: 10.1002/14651858.CD009178.pub3.'}, {'pmid': '25515275', 'type': 'BACKGROUND', 'citation': 'Chien MY, Chen HC. Poor sleep quality is independently associated with physical disability in older adults. J Clin Sleep Med. 2015 Mar 15;11(3):225-32. doi: 10.5664/jcsm.4532.'}, {'pmid': '34674490', 'type': 'DERIVED', 'citation': 'Morales-Delgado R, Camara-Lemarroy CR, Salinas-Martinez R, Gamez-Trevino D, Arredondo-Jaime A, Hernandez-Maldonado E, Guajardo-Alvarez G. A randomized placebo-controlled trial evaluating the effect of melatonin on sleep quality in patients with mild-moderate dementia. Eur Geriatr Med. 2018 Aug;9(4):449-454. doi: 10.1007/s41999-018-0068-9. Epub 2018 May 24.'}, {'pmid': '33189083', 'type': 'DERIVED', 'citation': 'McCleery J, Sharpley AL. Pharmacotherapies for sleep disturbances in dementia. Cochrane Database Syst Rev. 2020 Nov 15;11(11):CD009178. doi: 10.1002/14651858.CD009178.pub4.'}]}, 'descriptionModule': {'briefSummary': 'Introduction: Patients with dementia may suffer from poor sleep quality. Disturbance in the metabolism melatonin may have a role in the pathogenesis of sleep-wake cycle alterations in dementia.\n\nObjective: To evaluate the efficacy of low dose exogenous melatonin in improving sleep quality.\n\nDesign: A single-center randomized, double-blinded, placebo-controlled study carried out on outpatients with dementia and sleep alterations.\n\nParticipants: The investigators calculated a 40 individuals aged 65 years or over with a diagnosis of mild-moderate dementia (Clinical Dementia Rating 1-2).\n\nIntervention: Patients were randomized to receive either 5 mg of melatonin or placebo every night for 8 weeks.\n\nMeasurements: The primary outcome was sleep quality according to the Pittsburgh Sleep Quality Index (PSQI).', 'detailedDescription': 'This is a single-center study. The study protocol, informed consents, and amendments were approved in writing by the appropriate local site Independent Ethics Committee (IEC)/Institutional Review Boards (IRB) (Ethics Committee of the Universidad Autónoma de Nuevo León, School of Medicine).\n\nThe patients were recruited as outpatients from the Geriatrics Clinic. A total of 67 patients were screened out of which 40 male and female patients diagnosed with mild to moderate dementia were recruited to the study. Following inclusion, all patients underwent randomization to treatment with melatonin (5 mg orally) or placebo for 8 weeks. To prevent bias, matching placebo tablets, which were identical in appearance, taste, and odor, were used. The treatment was double-blinded, with two parallel treatment groups. Selection for a treatment group was determined by a computer-generated randomization list, in a 1:1 ratio using the randomized permuted blocks method.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Older than 60 years;\n* Circadian cycle sleep disorder with insomnia (according to Diagnostic and Statistical Manual of Mental Disorders- V criteria);\n* Mild or moderate dementia (clinical dementia rating 1 and 2);\n* Medications such as anti-depressants, acetylcholinesterase inhibitors, antipsychotics or memantine were allowed as long as they were initiated for over 8 weeks.\n\nExclusion Criteria:\n\n* They had other diagnoses of sleep disorders, known hypersensitivity to melatonin, use of stimulants or hypnotics, recent diagnosis (within 8 weeks) of mood disorders or neuropsychiatric symptoms.'}, 'identificationModule': {'nctId': 'NCT03066518', 'briefTitle': 'Effect of Melatonin on Sleep Quality in Patients Dementia', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitario Dr. Jose E. Gonzalez'}, 'officialTitle': 'A Randomized Placebo-controlled Trial Evaluating the Effect of Melatonin on Sleep Quality in Patients With Dementia', 'orgStudyIdInfo': {'id': 'GE15-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Melatonin', 'description': 'Melatonin 5 mg, daily, eight weeks', 'interventionNames': ['Drug: Melatonin 5 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'Placebo, daily, eight weeks', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Melatonin 5 mg', 'type': 'DRUG', 'otherNames': ['Benedorm'], 'armGroupLabels': ['Melatonin']}, {'name': 'Placebo', 'type': 'OTHER', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Guillermo Guajardo, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'HUGonzález'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitario Dr. Jose E. Gonzalez', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Rocio Morales Delgado', 'investigatorAffiliation': 'Hospital Universitario Dr. Jose E. Gonzalez'}}}}