Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-25 @ 8:50 PM
Study NCT ID:
NCT00404456
Status:
COMPLETED
Last Update Posted:
2008-01-29
First Post:
2006-11-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Efficacy of Melatonin in Sleep Problems of Hemodialysis and Peritoneal Dialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020447', 'term': 'Parasomnias'}], 'ancestors': [{'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008550', 'term': 'Melatonin'}], '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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-01', 'completionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-01-28', 'studyFirstSubmitDate': '2006-11-27', 'studyFirstSubmitQcDate': '2006-11-27', 'lastUpdatePostDateStruct': {'date': '2008-01-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-11-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sleep onset latency < 15 minutes'}, {'measure': 'sleep efficiency > 85%'}, {'measure': 'Normalized melatonin rhythm. Dim Light Melatonin Onset (DLMO) 21:00-23:00 hour'}]}, 'conditionsModule': {'conditions': ['Hemodialysis', 'Peritoneal Dialysis', 'Sleep Problems']}, 'referencesModule': {'references': [{'pmid': '19076157', 'type': 'DERIVED', 'citation': 'Koch BC, Nagtegaal JE, Hagen EC, van der Westerlaken MM, Boringa JB, Kerkhof GA, Ter Wee PM. The effects of melatonin on sleep-wake rhythm of daytime haemodialysis patients: a randomized, placebo-controlled, cross-over study (EMSCAP study). Br J Clin Pharmacol. 2009 Jan;67(1):68-75. doi: 10.1111/j.1365-2125.2008.03320.x. Epub 2008 Nov 17.'}]}, 'descriptionModule': {'briefSummary': 'Sleep problems can lead to a bad quality of life and a raise of morbidity, also in dialysis patients. Sleep problems can be caused by a disturbance of circadian rhythms in our body. For a good regulation of these circadian rhythms a uniform external synchronisation is necessary. This is the synchronisation of the biological clock of our body by light and other influences. In case of a disturbance of the external synchronisation, due to for example naps during the day or wake periods at night, internal rhythms can be unlinked. As a result a weakened melatonin rhythm and a problematic sleep-wake cycle can be observed. Most dialysis patients have sleep problems. Their sleep latency is prolonged. They often take a nap during the day and their sleep efficiency is poor. There has only been one study on the melatonin rhythm of dialysis patients. The conclusion of this study was that the melatonin rhythm of dialysis patients is weakened and disturbed, probably caused by renal insufficiency. In this study no link was made between melatonin rhythm and the nature and severity of possible sleep problems. In different studies with non-dialysis patients and a disturbed melatonin rhythm, exogenous melatonin at the right time leads to a recovery of the normal rhythm and the normal biological clock and a better quality of life.\n\nThe aim is to research the endogenous melatonin rhythm and to improve sleep problems of hemodialysis patients with a placebo-controlled study with exogenous melatonin. Next to this a substudy is performed, in which the effect of the change of daytime to nocturnal in hospital hemodialysis on sleep and melatonin is researched.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stable Peritoneal dialysis\n* Stable Hemodialysis\n* Age 18-85 years\n\nExclusion Criteria:\n\n* use of hypnotics, MAO inhibitors or neuroleptics\n* Liver disease\n* Participation in drug investigation \\< 1 months to start\n* Former use of melatonin\n* Severe neurological/psychiatric disease\n* Allergic to melatonin or additives'}, 'identificationModule': {'nctId': 'NCT00404456', 'briefTitle': 'The Efficacy of Melatonin in Sleep Problems of Hemodialysis and Peritoneal Dialysis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Meander Medical Center'}, 'officialTitle': 'The Efficacy of Melatonin in Sleep Problems of Hemodialysis and Peritoneal Dialysis Patients', 'orgStudyIdInfo': {'id': 'EMSCAP'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Melatonin', 'type': 'DRUG', 'description': 'Melatonin 3 mg once-daily'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3818 ES', 'city': 'Amersfoort', 'country': 'Netherlands', 'facility': 'Meander Medical Center', 'geoPoint': {'lat': 52.155, 'lon': 5.3875}}], 'overallOfficials': [{'name': 'Piet ter Wee, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Amsterdam UMC, location VUmc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meander Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dutch Kidney Foundation', 'class': 'OTHER'}]}}}