Ignite Creation Date:
2025-12-24 @ 12:34 PM
Ignite Modification Date:
2025-12-31 @ 8:22 AM
Study NCT ID:
NCT01493661
Status:
COMPLETED
Last Update Posted:
2016-02-03
First Post:
2011-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chronic Sleep Restriction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012892', 'term': 'Sleep Deprivation'}], 'ancestors': [{'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012890', 'term': 'Sleep'}], 'ancestors': [{'id': 'D009424', 'term': 'Nervous System Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-02', 'studyFirstSubmitDate': '2011-12-14', 'studyFirstSubmitQcDate': '2011-12-15', 'lastUpdatePostDateStruct': {'date': '2016-02-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Sleep', 'Polysomnography', 'Reaction Time', 'Sleep Deprivation', 'Psychophysiology', 'Chronic sleep restriction', 'healthy', 'without sleep complaints'], 'conditions': ['Other Conditions That May Be A Focus of Clinical Attention']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.fapesp.br/', 'label': 'Fundação de Amparo à Pesquisa do Estado de São Paulo'}]}, 'descriptionModule': {'briefSummary': 'Sleep is a physiological state considered essential for health and human survival. The prevalence of chronic sleep restriction has increased in modern society, as well as the effects of the same health concerns about various aspects, including the physiological and neurobehavioral. The objective of this study is to identify the neurobehavioral and physiological responses of healthy men with different needs of total sleep time (TST) submitted to chronic sleep restriction. Participants in this study will be 30 male volunteers, aged between 20 and 35 years, divided into three groups: Group 1 (n = 10) with TST ≤ 6 hours (h), Group 2 (n = 10) with TST ≥ 9h and Group 3 (n = 10): TST with between 7 and 8h. The TST will be established by the constant and continuous use of actigraphy for 10 days prior to the onset of the experimental protocol. All volunteers will undergo medical and polysomnography (PSG) examination to detect the presence or not of changes in sleep as well as other health problem that prevents their participation in the study. The experimental protocol consists of a basal night of sleep, five consecutive nights of chronic sleep restriction to 25% of TST in the beginning night and a night of recovery, which will be allowed to sleep the sleep pattern. Each night will have PSG monitoring and when wake up in each day, the volunteer will undergo tests to assess the physiological and neurobehavioral variables. The significance level will be 5% (p ≤ 0.05).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Community sample, residents of Sao Paulo city', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body Mass Index ≤ 25 kg/m2\n* Physically active individuals\n* 8 years of school education.\n\nExclusion Criteria:\n\n* High level of anxiety - State-Trait Anxiety Inventory (STAI-T) ≥ 35\n* High level of anxiety - Beck Depression Inventory ≥ 19\n* PSQI - Pittsburgh Sleep Quality Index ≥ 11\n* ESS - Epworth Sleepiness Scale ≥ 15\n* Irregular rhythm of sleep identified by actigraphy\n* Sleep disturbance by polysomnography\n* Shift worker or nocturnal worker;\n* Obesity;\n* Smoker;\n* Alcohol Intake of more than 3 drinks per day;\n* Taking sleep medications or illicit drugs.'}, 'identificationModule': {'nctId': 'NCT01493661', 'acronym': 'CSR', 'briefTitle': 'Chronic Sleep Restriction', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of São Paulo'}, 'officialTitle': 'Chronic Sleep Restriction: Neurobehavioral and Physiological Responses', 'orgStudyIdInfo': {'id': 'CEPE2011SSQueiroz'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'Men with Total Sleep Time ≤ 6h that will undergo 25 percent of chronic sleep restriction of their TST', 'interventionNames': ['Other: Chronic Sleep Restriction']}, {'label': 'Group 2', 'description': 'Men with Total Sleep Time (range 7-8h)that will undergo 25 percent of chronic sleep restriction of their TST', 'interventionNames': ['Other: Chronic Sleep Restriction']}, {'label': 'Group 3', 'description': 'Men with Total Sleep Time ≥ 9h that will undergo 25 percent of chronic sleep restriction of their TST', 'interventionNames': ['Other: Chronic Sleep Restriction']}], 'interventions': [{'name': 'Chronic Sleep Restriction', 'type': 'OTHER', 'otherNames': ['Chronic', 'Sleep', 'Restriction'], 'description': 'All volunteers will undergo 25% of sleep restriction of their total sleep time at the beginning sleep for five consecutive days. The nights will be monitored by polysomnography.', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04020-050', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Federal University of Sao Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Marco T De Mello, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federal University of São Paulo'}, {'name': 'Juliana MS Prado, Ph.D', 'role': 'STUDY_CHAIR', 'affiliation': 'Federal University of São Paulo'}, {'name': 'Patricia Rzezak, Ph.D', 'role': 'STUDY_CHAIR', 'affiliation': 'Federal University of São Paulo'}, {'name': 'Sergio Tufik, Ph.D', 'role': 'STUDY_CHAIR', 'affiliation': 'Federal University of São Paulo'}, {'name': 'Sandra S De Queiroz', 'role': 'STUDY_CHAIR', 'affiliation': 'Federal University of São Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of São Paulo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Associação Fundo de Incentivo à Pesquisa', 'class': 'OTHER'}, {'name': 'Fundação de Amparo à Pesquisa do Estado de São Paulo', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ph.D', 'investigatorFullName': 'Marco Tulio de Mello', 'investigatorAffiliation': 'Federal University of São Paulo'}}}}