Nctid:
NCT00001546
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-09-05"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000012893", "term"=>"Sleep Wake Disorders"}, {"id"=>"D000020447", "term"=>"Parasomnias"}], "ancestors"=>[{"id"=>"D000009422", "term"=>"Nervous System Diseases"}, {"id"=>"D000009461", "term"=>"Neurologic Manifestations"}, {"id"=>"D000001523", "term"=>"Mental Disorders"}], "browseLeaves"=>[{"id"=>"M22242", "name"=>"Parasomnias", "asFound"=>"Sleep Disorders", "relevance"=>"HIGH"}, {"id"=>"M15696", "name"=>"Sleep Wake Disorders", "asFound"=>"Sleep Disorders", "relevance"=>"HIGH"}, {"id"=>"M12404", "name"=>"Neurologic Manifestations", "relevance"=>"LOW"}, {"id"=>"M4815", "name"=>"Mental Disorders", "relevance"=>"LOW"}, {"id"=>"M14473", "name"=>"Psychotic Disorders", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Behaviors and Mental Disorders", "abbrev"=>"BXM"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M11533", "name"=>"Melatonin", "relevance"=>"LOW"}, {"id"=>"T410", "name"=>"Melatonin", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Central Nervous System Depressants", "abbrev"=>"CNSDep"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Other Dietary Supplements", "abbrev"=>"Ot"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "enrollmentInfo"=>{"count"=>38}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1996-05"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"1999-04", "completionDateStruct"=>{"date"=>"2000-06"}, "lastUpdateSubmitDate"=>"2008-03-03", "studyFirstSubmitDate"=>"1999-11-03", "studyFirstSubmitQcDate"=>"2002-12-09", "lastUpdatePostDateStruct"=>{"date"=>"2008-03-04", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2002-12-10", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["Biochemical Screening", "Body Temperature", "Consent Form", "EEG", "EKG", "Melatonin", "Mood", "Physical Examination", "Psychiatric Examination", "Sleep Duration", "Sleep Disorders"], "conditions"=>["Sleep Disorders"]}, "referencesModule"=>{"references"=>[{"pmid"=>"7185792", "type"=>"BACKGROUND", "citation"=>"Borbely AA. A two process model of sleep regulation. Hum Neurobiol. 1982;1(3):195-204. No abstract available."}, {"pmid"=>"8769783", "type"=>"BACKGROUND", "citation"=>"Aeschbach D, Cajochen C, Landolt H, Borbely AA. Homeostatic sleep regulation in habitual short sleepers and long sleepers. Am J Physiol. 1996 Jan;270(1 Pt 2):R41-53. doi: 10.1152/ajpregu.1996.270.1.R41."}, {"pmid"=>"6165548", "type"=>"BACKGROUND", "citation"=>"Borbely AA, Baumann F, Brandeis D, Strauch I, Lehmann D. Sleep deprivation: effect on sleep stages and EEG power density in man. Electroencephalogr Clin Neurophysiol. 1981 May;51(5):483-95. doi: 10.1016/0013-4694(81)90225-x."}]}, "descriptionModule"=>{"briefSummary"=>"Routine sleep duration varies greatly among individuals. The biological meaning of this variation is unknown.\n\nThe term circadian rhythm refers to the biological clock that regulates the timing of falling asleep, waking up, and secretion of hormones, like melatonin. Melatonin is secreted at night. Previous studies have shown that melatonin may play a role in the regulation of sleep.\n\nThe purpose of this study is to learn whether the duration of nighttime (nocturnal) melatonin secretion is longer in people with long regular sleep duration than people with short sleep duration.\n\nResearchers will compare levels of melatonin and cortisol, body temperature, sleepiness, and sleep in two extreme groups. Group one will be made up of people with short sleep duration lasting less than 6 hours. Group two will be made up of people with long sleep duration lasting more than 9 hours.", "detailedDescription"=>"Habitual sleep duration varies greatly among individuals. The biological meaning of this variation is unknown. The present project proposes that differences in habitual sleep duration are associated with differences in the output of the endogenous circadian pacemaker, which programs the 'internal biological night'. The protocol hypothesizes that the duration of the internal biological night as defined by the nocturnal intervals of detectable plasma melatonin levels, low body temperature, low EEG activity in the high-frequency alpha band, increasing sleepiness and increasing plasma cortisol levels is longer in habitual long sleepers (sleep duration greater than 9 hours) than in short sleepers (less than 6 hours). Since recent results in healthy subjects suggest that melatonin has some soporific or hypnotic properties, we furthermore hypothesize that the level of nocturnal melatonin secretion is higher in long sleepers than in short sleepers. The circadian rhythms of plasma melatonin, body temperature, waking EEG activity, subjective sleepiness and plasma cortisol will be assessed in a \\~40-hour constant routine protocol. In addition, a 36-hour extended bed rest protocol will be carried out in order to study spontaneous sleep duration and sleep structure under ad lib conditions while time cues and social cues are absent. It is hypothesized that as a consequence of differences in the circadian output, long sleepers will sleep more, have a different sleep structure, and spontaneously wake up on a lower level of homeostatic sleep pressure than short sleepers. Finally, we intend to determine whether differences in habitual sleep duration between long and short sleepers are associated with dysthymic and hypomanic characteristics of mood, respectively. We are asking to study a total of 15 long sleepers and 15 short sleepers. Given that we have already studied 9 long sleepers and 9 short sleepers, we anticipate that 72 patient-days per year for one year would be required to complete the study."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "healthyVolunteers"=>true, "eligibilityCriteria"=>"Sleep greater than or equal to 9 hours almost every night.\n\nSleep less than or equal to 6 hours almost every night.\n\nBetween ages 20-30.\n\nNo medications, history of psychiatric illness, history of head injury.\n\nNo sleep disturbances."}, "identificationModule"=>{"nctId"=>"NCT00001546", "briefTitle"=>"Circadian Regulation of Sleep in Habitual Short Sleepers and Long Sleepers", "organization"=>{"class"=>"NIH", "fullName"=>"National Institutes of Health Clinical Center (CC)"}, "officialTitle"=>"Circadian Regulation of Sleep in Habitual Short Sleepers and Long Sleepers", "orgStudyIdInfo"=>{"id"=>"960087"}, "secondaryIdInfos"=>[{"id"=>"96-M-0087"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"20892", "city"=>"Bethesda", "state"=>"Maryland", "country"=>"United States", "facility"=>"National Institute of Mental Health (NIMH)", "geoPoint"=>{"lat"=>38.98067, "lon"=>-77.10026}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Mental Health (NIMH)", "class"=>"NIH"}}}}