Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 10:11 PM
Study NCT ID:
NCT05880758
Status:
RECRUITING
Last Update Posted:
2025-05-14
First Post:
2023-05-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Yo-Yo Sleep on Cardiometabolic Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Statistician will be blinded to intervention allocation; blinding of study participants is not possible due to the intervention type.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '3-arm, parallel study design'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 72}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2028-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-12', 'studyFirstSubmitDate': '2023-05-17', 'studyFirstSubmitQcDate': '2023-05-25', 'lastUpdatePostDateStruct': {'date': '2025-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fasting Plasma Glucose', 'timeFrame': 'Up to 4 weeks', 'description': 'Insulin resistance will be assessed by measuring fasting plasma glucose levels.'}, {'measure': 'Insulin Level', 'timeFrame': 'Up to 4 weeks', 'description': 'Insulin resistance will be assessed by measuring insulin levels.'}, {'measure': 'Morning Systolic and Diastolic Blood Pressure', 'timeFrame': 'Up to 4 weeks', 'description': 'Ambulatory blood pressure will be measured.'}, {'measure': 'Evening Systolic and Diastolic Blood Pressure', 'timeFrame': 'Up to 4 weeks', 'description': 'Ambulatory blood pressure will be measured.'}, {'measure': 'Fat mass', 'timeFrame': 'Up to 4 weeks', 'description': 'Body composition will be measured using Dual-energy X-ray absorptiometry (DXA) to determine fat mass.'}], 'secondaryOutcomes': [{'measure': 'Low-density Lipoprotein (LDL) Level', 'timeFrame': 'Up to 4 weeks', 'description': 'Lipid panel will be assessed.'}, {'measure': 'High-density Lipoprotein (HDL) Level', 'timeFrame': 'Up to 4 weeks', 'description': 'Lipid panel will be assessed.'}, {'measure': 'Total Cholesterol Level', 'timeFrame': 'Up to 4 weeks', 'description': 'Lipid panel will be assessed.'}, {'measure': 'Triglyceride Level', 'timeFrame': 'Up to 4 weeks', 'description': 'Lipid panel will be assessed.'}, {'measure': 'C-reactive protein (CRP) Level', 'timeFrame': 'Up to 4 weeks', 'description': 'CRP will be measured as an inflammatory marker.'}, {'measure': 'Interleukin 6 (IL-6)', 'timeFrame': 'Up to 4 weeks', 'description': 'IL-6 will be measured as an inflammatory marker.'}, {'measure': 'Tumor necrosis factor alpha (TNF-alpha)', 'timeFrame': 'Up to 4 weeks', 'description': 'TNF-alpha will be measured as an inflammatory marker.'}, {'measure': 'Total daily energy expenditure', 'timeFrame': 'Baseline and endpoint (4 weeks)', 'description': 'Energy expenditure will be measured using doubly-labeled water over 14 days'}, {'measure': 'Energy Intake', 'timeFrame': 'Baseline and endpoint (4 weeks)', 'description': 'Energy intake will be measured to assess diet quality using daily food records for 7 days.'}, {'measure': 'Total Ghrelin', 'timeFrame': '2 hours post meal at baseline and endpoint (4 weeks)', 'description': 'Total ghrelin will be assessed using radioimmunoassay (RIA).'}, {'measure': 'Serum Leptin', 'timeFrame': '2 hours post meal at baseline and endpoint (4 weeks)', 'description': 'Serum leptin will be measured using a double-antibody RIA.'}, {'measure': 'Adiponectin Level', 'timeFrame': 'Up to 4 weeks', 'description': 'Adiponectin levels will be analyzed using RIA.'}, {'measure': 'Glucagon-like peptide 1 (GLP-1) Level', 'timeFrame': '2 hours post meal at baseline and endpoint (4 weeks)', 'description': 'GLP-1 will be measured by RIA after plasma extraction with 95% ethanol.'}, {'measure': 'Change in Nuclear factor kappa B (NFkB) Level', 'timeFrame': 'Baseline and endpoint (4 weeks)', 'description': 'NFkB will be measured to assess endothelial cell inflammation.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sleep', 'Circadian Rhythms', 'Cardiometabolic Health'], 'conditions': ['Cardiometabolic Syndrome', 'Obesity']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to test the impact of repeated intermittent short sleep, with short sleep maintained 5 days per week followed by 2 days of prolonged sleep, compared to daily adequate sleep, on energy balance and cardiometabolic risk. A secondary goal of this research is to determine if maintaining a constant midpoint of sleep while undergoing intermittent short sleep, leads to better outcomes than intermittent short sleep with a 2-hour delay in sleep midpoint. The aims of this research will be tested in the context of a 3-group, parallel-arm, outpatient intervention of 4 weeks in duration, in young-to-middle-aged adults (aged 18-49 years).', 'detailedDescription': 'A large portion of the U.S. adult population reports insufficient sleep on a nightly basis. It has been shown that sustained insufficient sleep leads to adverse cardiometabolic risk profile and positive energy balance. However, sleep patterns in real life are not consistent over weeks. Individuals not obtaining sufficient sleep during the week may compensate by sleeping longer on weekends. The differences in sleep duration between week and weekend nights is approximately 1 hour, mostly due to delaying wake times rather than advancing bedtimes. A drawback of such behaviors is resultant change in sleep midpoint, which has been associated with adverse cardiometabolic health and obesity. However, very few studies have attempted to determine whether recovery sleep on weekends results in reversal of adverse health effects of insufficient sleep during the week. Available studies suggest that recovery sleep does not revert health markers to pre-sleep restriction (SR) levels. But these studies are short, usually involving only one cycle of SR followed by recovery sleep, and fail to use appropriate and robust statistical methods. Therefore, the goal of the current investigation is to evaluate the impact of repeated intermittent short sleep, with short sleep maintained 5 days/week followed by 2 days of recovery sleep, relative to daily adequate sleep, on energy balance and cardiometabolic risk markers. A secondary goal of this research is to determine if maintaining a constant sleep timing while undergoing intermittent short sleep, leads to better outcomes than intermittent short sleep in conjunction with shifts in sleep times.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18 to 49 years\n* BMI 20-29.9 kg/m2\n* Habitually sleeping 7-9 hours/night without sleep aids or naps\n\nExclusion Criteria:\n\n* Sleep disorders\n* Psychiatric disorders (including eating disorders) and seasonal affective disorder\n* Pregnancy (current/prior year)\n* Breastfeeding\n* Smokers (Any cigarette smoking or ex-smokers \\<3years)\n* Diabetes\n* Elevated blood pressure, taking beta-blockers\n* Individuals taking anti-coagulants or anti-platelets\n* Recent weight change or participation in a weight loss program or have ever had bariatric surgery or other weight loss or gastrointestinal procedure.\n* Travel across time zones; shift work (non-traditional hours)'}, 'identificationModule': {'nctId': 'NCT05880758', 'briefTitle': 'Impact of Yo-Yo Sleep on Cardiometabolic Health', 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': 'Impact of Yo-Yo Sleep on Cardiometabolic Health', 'orgStudyIdInfo': {'id': 'AAAU3694'}, 'secondaryIdInfos': [{'id': 'R35HL155670', 'link': 'https://reporter.nih.gov/quickSearch/R35HL155670', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Stable Adequate Sleep (SAS)', 'description': 'Participants will go to bed and wake up at the same time every night, maintaining adequate sleep duration.', 'interventionNames': ['Behavioral: Sustained Adequate Sleep (SAS)']}, {'type': 'EXPERIMENTAL', 'label': 'ISS_Alone', 'description': 'Intermittent short sleep (ISS) 5 nights of 5.5 hours time in bed 2 nights of 9.5 hours time in bed with advanced bedtimes and delayed wake times', 'interventionNames': ['Behavioral: Intermittent Short Sleep (ISS)']}, {'type': 'EXPERIMENTAL', 'label': 'ISS_SJL', 'description': 'Intermittent short sleep with short jetlag (SJL) 5 nights of 5.5 hours time in bed 2 nights of 9.5 hours time in bed with constant bedtimes and delayed wake times', 'interventionNames': ['Behavioral: Intermittent Short Sleep (ISS)', 'Behavioral: Social Jetlag (SJL)']}], 'interventions': [{'name': 'Intermittent Short Sleep (ISS)', 'type': 'BEHAVIORAL', 'otherNames': ['ISS'], 'description': 'Restricted sleep duration of \\<5.5 h/night for 5 nights (SR) followed by 2 nights of 9.5 hours of time in bed (TIB) (recover sleep) each week.', 'armGroupLabels': ['ISS_Alone', 'ISS_SJL']}, {'name': 'Social Jetlag (SJL)', 'type': 'BEHAVIORAL', 'otherNames': ['SJL'], 'description': '2-hour delayed sleep timing.', 'armGroupLabels': ['ISS_SJL']}, {'name': 'Sustained Adequate Sleep (SAS)', 'type': 'BEHAVIORAL', 'otherNames': ['SAS'], 'description': 'Goal of ≥7 hours of sleep/night with 8 hours of time in bed (TIB).', 'armGroupLabels': ['Stable Adequate Sleep (SAS)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Marie-Pierre St-Onge, PhD', 'role': 'CONTACT', 'email': 'ms2554@cumc.columbia.edu', 'phone': '212-305-9549'}, {'name': 'Marie-Pierre St-Onge, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Sanja Jelic, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Columbia University Irving Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'centralContacts': [{'name': 'Marie-Pierre St-Onge, PhD', 'role': 'CONTACT', 'email': 'ms2554@cumc.columbia.edu', 'phone': '212-305-9549'}, {'name': 'Greiby Mercedes', 'role': 'CONTACT', 'email': 'gdm2130@cumc.columbia.edu', 'phone': '646-761-3455'}], 'overallOfficials': [{'name': 'Marie-Pierre St-Onge, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Data will become available after results of the main aims from the final dataset have been accepted for publication.', 'ipdSharing': 'YES', 'description': "Data from this study will be available for sharing with other investigators. Data sharing requests should be made in writing and sent directly to the investigator(s) who generated the data. The purposes for using shared data should be stated in the request, and the data can only be used for research purposes. Data sharing agreements should be developed and accepted by both parties before data sharing takes place. Protecting the rights and privacy of human subjects and maintaining the study participants' confidentiality will be the first priority of our data sharing plan. HIPAA privacy rule for de-identification of a dataset will be followed before transferring data.", 'accessCriteria': 'Contact PI for information on data availability and data sharing.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Columbia University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Icahn School of Medicine at Mount Sinai', 'class': 'OTHER'}, {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, {'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Marie-Pierre St-Onge', 'investigatorAffiliation': 'Columbia University'}}}}