Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2026-01-15 @ 10:28 AM
Study NCT ID:
NCT05313932
Status:
UNKNOWN
Last Update Posted:
2022-04-06
First Post:
2022-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Sleep Deprivation on Physiological and Perceptual Responses During Exercise
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-04-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-09-26', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-29', 'studyFirstSubmitDate': '2022-03-29', 'studyFirstSubmitQcDate': '2022-03-29', 'lastUpdatePostDateStruct': {'date': '2022-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oxygen uptake', 'timeFrame': 'From baseline to completion, up to 31 days', 'description': 'Change from baseline in oxygen uptake measured breath-by-breath using an online gas analyzer during submaximal and maximal incremental exercise'}, {'measure': 'Respiratory exchange ratio', 'timeFrame': 'From baseline to completion, up to 31 days', 'description': 'Change from baseline in respiratory exchange ratio measured breath-by-breath using an online gas analyzer during submaximal and maximal incremental exercise'}, {'measure': 'Breathing frequency', 'timeFrame': 'From baseline to completion, up to 31 days', 'description': 'Change from baseline in breathing frequency measured breath-by-breath using an online gas analyzer during submaximal and maximal incremental exercise'}, {'measure': 'Minute ventilation', 'timeFrame': 'From baseline to completion, up to 31 days', 'description': 'Change from baseline in minute ventilation measured breath-by-breath using an online gas analyzer during submaximal and maximal incremental exercise'}, {'measure': 'Blood lactate concentration', 'timeFrame': 'From baseline to completion, up to 31 days', 'description': 'Change from baseline in blood lactate concentration measured using capillary puncture during submaximal and maximal incremental exercise'}, {'measure': 'Rating of perceived exertion', 'timeFrame': 'From baseline to completion, up to 31 days', 'description': 'Change from baseline in ratings of perceived exertion measured using a 15-point (6-20) scale during submaximal and maximal incremental exercise'}, {'measure': 'Heart rate', 'timeFrame': 'From baseline to completion, up to 31 days', 'description': 'Change from baseline in heart rate measured using a heart rate monitor during submaximal and maximal incremental exercise'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sleep Deprivation']}, 'descriptionModule': {'briefSummary': 'Sleep deprivation has been found to impact exercise performance. The effects of both partial (several hours) and full (24+ hours) sleep deprivation on exercise performance has shown effects on rating of perceived exertion, rate of oxygen consumption, respiratory exchange ratio, and heart rate. A common practice with athletes is to perform regular physiological testing (submaximal and maximal) in order to assess their fitness and to determine training intensities. However, the effects of sleep deprivation on those same physiological test results has not been investigated Therefore, the purpose of this study is to investigate the effects of partial sleep deprivation on physiological test results.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Injury-free, trained, male runners\n\nExclusion Criteria:\n\n* Female, untrained, injured'}, 'identificationModule': {'nctId': 'NCT05313932', 'briefTitle': 'The Effects of Sleep Deprivation on Physiological and Perceptual Responses During Exercise', 'organization': {'class': 'OTHER', 'fullName': "St Mary's University College"}, 'officialTitle': 'The Effects of Partial Sleep Restriction on Physiological and Perceptual Responses During Submaximal and Maximal Exercise in Trained Runners', 'orgStudyIdInfo': {'id': 'StMarysUC4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sleep deprivation', 'description': 'Two hours of sleep deprivation (Six hours of sleep)', 'interventionNames': ['Other: Sleep deprivation']}, {'type': 'NO_INTERVENTION', 'label': 'No intervention', 'description': 'No sleep deprivation (Eight hours of sleep)'}], 'interventions': [{'name': 'Sleep deprivation', 'type': 'OTHER', 'description': 'Participants wake after six hours so that they are deprived of 2 hours of sleep', 'armGroupLabels': ['Sleep deprivation']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St Mary's University College", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}