Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2026-02-23 @ 12:21 PM
Study NCT ID:
NCT02117193
Status:
COMPLETED
Last Update Posted:
2016-12-21
First Post:
2014-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Combined and Isolated Effects of Sleep Deprivation and Alcohol Intake on Exercise Performance in Humans.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000428', 'term': 'Alcohol Drinking'}, {'id': 'D012892', 'term': 'Sleep Deprivation'}], 'ancestors': [{'id': 'D004327', 'term': 'Drinking Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'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': 'D000431', 'term': 'Ethanol'}], 'ancestors': [{'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'marcovaz@esef.ufrgs.br', 'phone': '555133085860', 'title': 'Dr Marco Aurélio Vaz', 'organization': 'Federal University of Rio Grande do Sul'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Alcohol Intake + Normal Sleep', 'description': '1 g/kg of etanol combined with 8 hours of normal sleep', 'otherNumAtRisk': 10, 'otherNumAffected': 5, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Alcohol Intake + Sleep Deprivation', 'description': '1 g/kg of etanol combined with 8 hours of sleep deprivation', 'otherNumAtRisk': 10, 'otherNumAffected': 8, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo Intake + Normal Sleep', 'description': 'Placebo (beer without alcohol in the same volume to beer with alcohol) combined with 8 hours of normal sleep', 'otherNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Placebo Intake + Sleep Deprivation', 'description': 'Placebo (beer without alcohol in the same volume to beer with alcohol) combined with 8 hours of sleep deprivation', 'otherNumAtRisk': 10, 'otherNumAffected': 3, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 3}], 'organSystem': 'Nervous system disorders'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 3}], 'organSystem': 'Nervous system disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Aerobic Performance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sequence 1', 'description': 'Alcohol intake + Normal Sleep\n\nAlcohol intake: The subjects will be drink beer (1g/kg of ethanol) before sleep.\n\nNormal sleep: One night of normal sleep (8h)'}, {'id': 'OG001', 'title': 'Sequence 2', 'description': 'Alcohol intake + Sleep deprivation\n\nAlcohol intake: The subjects will be drink beer (1g/kg of ethanol) before sleep.\n\nSleep deprivation: One night of sleep deprivation (8h)'}, {'id': 'OG002', 'title': 'Sequence 3', 'description': 'Placebo intake + Normal Sleep\n\nPlacebo intake: The subjects will be drink beer (zero alcohol) before sleep.\n\nNormal sleep: One night of normal sleep (8h)'}, {'id': 'OG003', 'title': 'Sequence 4', 'description': 'Placebo intake + Sleep deprivation\n\nPlacebo intake: The subjects will be drink beer (zero alcohol) before sleep.\n\nSleep deprivation: One night of sleep deprivation (8h)'}], 'classes': [{'categories': [{'measurements': [{'value': '172', 'spread': '12.19', 'groupId': 'OG000'}, {'value': '173', 'spread': '9.2', 'groupId': 'OG001'}, {'value': '175', 'spread': '6.5', 'groupId': 'OG002'}, {'value': '176', 'spread': '11.4', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'After each sequence, up to 8 hours', 'description': "Aerobic performance will be determined through the subject's heart rate", 'unitOfMeasure': 'bpm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Neuromuscular Performance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sequence 1', 'description': 'Alcohol intake + Normal Sleep\n\nAlcohol intake: The subjects will be drink beer (1g/kg ethanol) before sleep.\n\nNormal sleep: One night of normal sleep (8h)'}, {'id': 'OG001', 'title': 'Sequence 2', 'description': 'Alcohol intake + Sleep deprivation\n\nAlcohol intake: The subjects will be drink beer (1g/kg ethanol) before sleep.\n\nSleep deprivation: One night of sleep deprivation (8h)'}, {'id': 'OG002', 'title': 'Sequence 3', 'description': 'Placebo intake + Normal Sleep\n\nPlacebo intake: The subjects will be drink beer (zero alcohol) before sleep.\n\nNormal sleep: One night of normal sleep (8h)'}, {'id': 'OG003', 'title': 'Sequence 4', 'description': 'Placebo intake + Sleep deprivation\n\nPlacebo intake: The subjects will be drink beer (zero alcohol) before sleep.\n\nSleep deprivation: One night of sleep deprivation (8h)'}], 'classes': [{'categories': [{'measurements': [{'value': '260.8', 'spread': '27.9', 'groupId': 'OG000'}, {'value': '242.3', 'spread': '34.3', 'groupId': 'OG001'}, {'value': '258.9', 'spread': '31.3', 'groupId': 'OG002'}, {'value': '249.5', 'spread': '33.9', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'After each sequence, up to 8 hours', 'description': 'knee extensor isometric torque', 'unitOfMeasure': 'Nm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Biochemical Responses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Alcohol Intake + Normal Sleep', 'description': '1g/kg of alcohol (beer) combined with 8 hours of normal sleep'}, {'id': 'OG001', 'title': 'Alcohol Intake + Sleep Deprivation', 'description': '1g/kg of alcohol (beer) combined with 8 hours of sleep deprivation'}, {'id': 'OG002', 'title': 'Placebo Intake + Normal Sleep', 'description': 'Placebo (beer without alcohol in the same volume to beer with alcohol) combined with 8 hours of normal sleep'}, {'id': 'OG003', 'title': 'Placebo Intake + Sleep Deprivation', 'description': 'Placebo (beer without alcohol in the same volume to beer with alcohol) combined with 8 hours of sleep deprivation'}], 'classes': [{'categories': [{'measurements': [{'value': '89.82', 'spread': '6.60', 'groupId': 'OG000'}, {'value': '84.76', 'spread': '4.03', 'groupId': 'OG001'}, {'value': '92.77', 'spread': '5.13', 'groupId': 'OG002'}, {'value': '92.85', 'spread': '8.26', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'After each sequence, up to 8 hours', 'description': 'Glucose after each situation in the morning', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hydration Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sequence 1', 'description': 'Alcohol intake + Normal Sleep\n\nAlcohol intake: The subjects will be drink beer (1g/kg of ethanol) before sleep.\n\nNormal sleep: One night of normal sleep (8h)'}, {'id': 'OG001', 'title': 'Sequence 2', 'description': 'Alcohol intake + Sleep Deprivation\n\nAlcohol intake: The subjects will be drink beer (1g/kg of ethanol) before sleep.\n\nSleep deprivation: One night of sleep deprivation (8h)'}, {'id': 'OG002', 'title': 'Sequence 3', 'description': 'Placebo intake + Normal Sleep\n\nPlacebo intake: The subjects will be drink beer (zero alcohol, in the same volume that alcohol intake) before sleep.\n\nNormal sleep: One night of normal sleep (8h)'}, {'id': 'OG003', 'title': 'Sequence 4', 'description': 'Placebo intake + Sleep deprivation\n\nPlacebo intake: The subjects will be drink beer (zero alcohol, in the same volume that alcohol intake) before sleep.\n\nSleep deprivation: One night of sleep deprivation (8h)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.017', 'spread': '0.006', 'groupId': 'OG000'}, {'value': '1.017', 'spread': '0.005', 'groupId': 'OG001'}, {'value': '1.015', 'spread': '0.003', 'groupId': 'OG002'}, {'value': '1.011', 'spread': '0.006', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'After each sequence, up to 8 hours', 'description': 'Urine Specific Gravity', 'unitOfMeasure': 'g/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Profile of Mood States', 'timeFrame': '6 months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Breath Alcohol', 'timeFrame': '6 months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Study Participants', 'description': 'This is a cross-over study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'Alcohol Intake + Normal Sleep', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'Placebo Intake + Normal Sleep', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'Alcohol Intake + Sleep Deprivation', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'Placebo Intake + Sleep Deprivation', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Participants', 'description': 'Received Alcohol intake + Normal Sleep Received Alcohol intake + Sleep Deprivation Received Placebo intake + Normal Sleep Received Placebo intake + Sleep Deprivation'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '23.5', 'spread': '3.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Brazil', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'maximal oxygen uptake', 'classes': [{'categories': [{'measurements': [{'value': '44.8', 'spread': '2.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'ml.kg-1.min-1', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-27', 'studyFirstSubmitDate': '2014-04-14', 'resultsFirstSubmitDate': '2016-05-10', 'studyFirstSubmitQcDate': '2014-04-15', 'lastUpdatePostDateStruct': {'date': '2016-12-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-08-01', 'studyFirstPostDateStruct': {'date': '2014-04-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Aerobic Performance', 'timeFrame': 'After each sequence, up to 8 hours', 'description': "Aerobic performance will be determined through the subject's heart rate"}, {'measure': 'Neuromuscular Performance', 'timeFrame': 'After each sequence, up to 8 hours', 'description': 'knee extensor isometric torque'}, {'measure': 'Biochemical Responses', 'timeFrame': 'After each sequence, up to 8 hours', 'description': 'Glucose after each situation in the morning'}], 'secondaryOutcomes': [{'measure': 'Hydration Status', 'timeFrame': 'After each sequence, up to 8 hours', 'description': 'Urine Specific Gravity'}, {'measure': 'Profile of Mood States', 'timeFrame': '6 months'}, {'measure': 'Breath Alcohol', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Alcohol Intake', 'Sleep Deprivation']}, 'descriptionModule': {'briefSummary': 'Although the effects of acute alcohol intake and sleep deprivation on exercise performance lacks evidence in the literature, in many situations, they occur simultaneously. Once the alcohol affects physiological processes, the processes that occur during sleep can be impaired, such as: suppression of GH release, action of neurotransmitters and neuromodulators in the CNS, changes in the proportion of sleep stages and may lead to suppression of REM sleep. These changes promote a significant functional impairment such as a reduction in alertness and modification in reaction time, which affects the performance of any activity of daily and professional life. However, the combined effects on the physical performance variables, such as aerobic and neuromuscular performance lack of evidence in the literature.', 'detailedDescription': 'Ten subjects were randomized in four situations after familiarization and control situation: (1) alcohol intake combined with sleep normal; (2) alcohol intake combined with sleep deprivation; (3) placebo intake combined with sleep normal and (4) placebo intake combined with sleep deprivation.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Physical active men\n\nExclusion Criteria:\n\n* AUDIT questionnaire above 15 points\n* Nocturnal Chronotype\n* Skeletal muscle injuries in upper and lower limb\n* Metabolic and cardiovascular disease'}, 'identificationModule': {'nctId': 'NCT02117193', 'briefTitle': 'Combined and Isolated Effects of Sleep Deprivation and Alcohol Intake on Exercise Performance in Humans.', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of Rio Grande do Sul'}, 'officialTitle': 'Combined and Isolated Effects of Sleep Deprivation and Alcohol Intake on Cardiorrespiratory, Neuromuscular and Hormonal Responses in Healthy Males.', 'orgStudyIdInfo': {'id': 'UFRGS 366465'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Alcohol intake', 'description': '1 g/kg of etanol combined. Beer without alcohol in the same volume will be used to placebo condition.', 'interventionNames': ['Other: Alcohol intake', 'Other: Sleep deprivation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'sleep deprivation', 'description': 'one night of sleep deprivation will be compared to 8h of normal sleep.', 'interventionNames': ['Other: Alcohol intake', 'Other: Sleep deprivation']}], 'interventions': [{'name': 'Alcohol intake', 'type': 'OTHER', 'description': 'The subjects will be drink beer (with or without alcohol) before sleep intervention (normal sleep and sleep deprivation).', 'armGroupLabels': ['Alcohol intake', 'sleep deprivation']}, {'name': 'Sleep deprivation', 'type': 'OTHER', 'description': 'One night of sleep deprivation or one night of normal sleep.', 'armGroupLabels': ['Alcohol intake', 'sleep deprivation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90690200', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Exercise Research Laboratory', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}], 'overallOfficials': [{'name': 'Rodrigo Rodrigues, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federal University of Rio Grande do Sul'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of Rio Grande do Sul', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil', 'class': 'OTHER'}, {'name': 'Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Marco Aurélio Vaz, PhD', 'investigatorAffiliation': 'Federal University of Rio Grande do Sul'}}}}