Ignite Creation Date:
2025-12-24 @ 11:51 AM
Ignite Modification Date:
2025-12-27 @ 12:05 PM
Study NCT ID:
NCT04956861
Status:
COMPLETED
Last Update Posted:
2025-01-23
First Post:
2021-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
HIV-1, Insufficient Sleep and Vascular Endothelial Dysfunction
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'desouzac@colorado.edu', 'phone': '303-492-2988', 'title': 'Christopher DeSouza Ph.D.', 'organization': 'University of Colorado'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Data was collected for participants while they were enrolled in the study. Each participant was in the study for a maximum of 4 months.', 'description': 'For simplicity in the reporting of the results with regards to the Adverse Event Table, Phase 1 the normal sleep duration group and the short sleep duration group are combined since no adverse events occurred or were reported.', 'eventGroups': [{'id': 'EG000', 'title': 'Phase 1: Cross-sectional Study', 'description': 'Phase 1 is a cross-sectional study to compare endothelial vasodilator (forearm blood flow) and fibrinolytic function (t-PA release) in ART-treated HIV-1-seropositive adults who habitually sleep more than 7 hours/night (normal sleep) and those who habitually sleep less than 7 hours/night (short sleep).', 'otherNumAtRisk': 78, 'deathsNumAtRisk': 78, 'otherNumAffected': 0, 'seriousNumAtRisk': 78, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Phase 2: Intervention Study', 'description': 'Phase 2 is an intervention study to determine the effects of individualized targeted sleep interventions that increase sleep duration and improve sleep quality on endothelial vasodilator (forearm blood flow) and fibrinolytic function (t-PA release) in ART-treated HIV-1-seropositive adults who habitually sleep less than 7 hours/night (short sleep).\n\nParticipants from phase 1 were invited to take part in phase 2.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Phase 1: Forearm Blood Flow (FBF) Response to Acetylcholine (ACh)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Sleep Duration', 'description': 'Normal Sleep Duration group slept \\>7 h/night.'}, {'id': 'OG001', 'title': 'Short Sleep Duration', 'description': 'Short Sleep Duration group slept \\<7h/night.'}], 'classes': [{'title': 'Saline', 'categories': [{'measurements': [{'value': '4.6', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '4.2', 'spread': '0.3', 'groupId': 'OG001'}]}]}, {'title': 'ACh 4.0', 'categories': [{'measurements': [{'value': '11.7', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '9.9', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'ACh 8.0', 'categories': [{'measurements': [{'value': '12.4', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '10.5', 'spread': '0.6', 'groupId': 'OG001'}]}]}, {'title': 'ACh 16.0', 'categories': [{'measurements': [{'value': '14.1', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '12.0', 'spread': '0.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'FBF response to ACh will be measured during Phase 1 at the participants visit 3 which is ~3 weeks from their respective start date.', 'description': 'FBF was measured via strain-gauge venous occlusion plethysmography in response to saline for 5 minutes and then to ACh (4.0, 8.0 and 16.0 ug/100 mL tissue/min; the doses of Acetylcholine infused into the brachial artery) for 5 minutes at each dose. Flows during the last minute of saline and each drug dose were measured and the mean value reported.\n\nValues after saline and after ACh 4.0, 8.0 and 16.0 at week 3 are reported.', 'unitOfMeasure': 'mL/100 mL tissue/min', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The number or participants analyzed is different than the participant flow module as these are the participants who completed visit 3.'}, {'type': 'PRIMARY', 'title': 'Phase 2: FBF Response to Acetylcholine (ACh)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2 Before Sleep Intervention', 'description': 'Phase 2 is an intervention study to determine the effects of individualized targeted sleep interventions that increase sleep duration and improve sleep quality on endothelial vasodilator and fibrinolytic function in Anti-retroviral-treated (ART) HIV-1-seropositive adults who habitually sleep less than 7 hours/night.'}, {'id': 'OG001', 'title': 'Phase 2 After Sleep Intervention', 'description': 'Phase 2 is an intervention study to determine the effects of individualized targeted sleep interventions that increase sleep duration and improve sleep quality on endothelial vasodilator and fibrinolytic function in Anti-retroviral-treated (ART) HIV-1-seropositive adults who habitually sleep less than 7 hours/night.\n\nIndividualized Targeted Sleep: The investigators will employ an 8-week individualized targeted sleep intervention. Individualized targeted interventions have the advantage of improving adherence, reducing attrition, and making the strategy personally meaningful.'}], 'classes': [{'title': 'Saline', 'categories': [{'measurements': [{'value': '4.2', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '0.3', 'groupId': 'OG001'}]}]}, {'title': 'ACh 4.0', 'categories': [{'measurements': [{'value': '9.2', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '11.1', 'spread': '0.7', 'groupId': 'OG001'}]}]}, {'title': 'Ach 8.0', 'categories': [{'measurements': [{'value': '9.9', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '12.2', 'spread': '0.7', 'groupId': 'OG001'}]}]}, {'title': 'Ach 16.0', 'categories': [{'measurements': [{'value': '11.3', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '14.0', 'spread': '0.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'FBF response to ACh will be measured during Phase 2 at the participants visit 9 which is ~11 weeks from their respective start date', 'description': 'FBF to ACh will be measured following the participants 8 week sleep intervention.', 'unitOfMeasure': 'mL/100 mL tissue/min', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Phase 1: Forearm Blood Flow (FBF) Response to Sodium Nitroprusside (NTP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Sleep Duration', 'description': 'Normal Sleep Duration group slept \\>7 h/night.'}, {'id': 'OG001', 'title': 'Short Sleep Duration', 'description': 'Short Sleep Duration group slept \\<7h/night.'}], 'classes': [{'title': 'Saline', 'categories': [{'measurements': [{'value': '4.8', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '0.3', 'groupId': 'OG001'}]}]}, {'title': 'NTP 1.0', 'categories': [{'measurements': [{'value': '13.9', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '12.4', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'NTP 2.0', 'categories': [{'measurements': [{'value': '16.1', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '14.5', 'spread': '0.7', 'groupId': 'OG001'}]}]}, {'title': 'NTP 4.0', 'categories': [{'measurements': [{'value': '17.0', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '16.7', 'spread': '0.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'FBF response to NTP will be measured during Phase 1 at the participants visit 3 which is ~3 weeks from their respective start date.', 'unitOfMeasure': 'mL/100 mL tissue/min', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The number or participants analyzed is different than the participant flow module due to availability of Sodium Nitroprusside.'}, {'type': 'PRIMARY', 'title': 'Phase 2: Forearm Blood Flow (FBF) Response to Sodium Nitroprusside (NTP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2 Before Sleep Intervention', 'description': 'Phase 2 is an intervention study to determine the effects of individualized targeted sleep interventions that increase sleep duration and improve sleep quality on endothelial vasodilator and fibrinolytic function in ART-treated HIV-1-seropositive adults who habitually sleep less than 7 hours/night.'}, {'id': 'OG001', 'title': 'Phase 2 After Sleep Intervention', 'description': 'Phase 2 is an intervention study to determine the effects of individualized targeted sleep interventions that increase sleep duration and improve sleep quality on endothelial vasodilator and fibrinolytic function in ART-treated HIV-1-seropositive adults who habitually sleep less than 7 hours/night.\n\nIndividualized Targeted Sleep: The investigators will employ an 8-week individualized targeted sleep intervention. Individualized targeted interventions have the advantage of improving adherence, reducing attrition, and making the strategy personally meaningful.'}], 'classes': [{'title': 'Saline', 'categories': [{'measurements': [{'value': '3.6', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '4.2', 'spread': '0.6', 'groupId': 'OG001'}]}]}, {'title': 'NTP 1.0', 'categories': [{'measurements': [{'value': '12.0', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '13.8', 'spread': '1.1', 'groupId': 'OG001'}]}]}, {'title': 'NTP 2.0', 'categories': [{'measurements': [{'value': '13.9', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '14.6', 'spread': '1.2', 'groupId': 'OG001'}]}]}, {'title': 'NTP 4.0', 'categories': [{'measurements': [{'value': '15.7', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '15.7', 'spread': '1.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'FBF response to NTP will be measured during Phase 2 at the participants visit 9 which is ~11 weeks from their respective start date', 'description': 'FBF to NTP will me measured following the participants 8 week sleep intervention', 'unitOfMeasure': 'mL/100 mL tissue/min', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Phase 1: Endothelial Tissue Type Plasminogen Activator (t-PA) Release in Response to Bradykinin (BDK)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Sleep Duration', 'description': 'Normal Sleep Duration group slept \\>7 h/night.'}, {'id': 'OG001', 'title': 'Short Sleep Duration', 'description': 'Short Sleep Duration group slept \\<7h/night.'}], 'classes': [{'title': 'Saline', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'BDK 12.5', 'categories': [{'measurements': [{'value': '20.9', 'spread': '3.2', 'groupId': 'OG000'}, {'value': '11.4', 'spread': '2.8', 'groupId': 'OG001'}]}]}, {'title': 'BDK 25.0', 'categories': [{'measurements': [{'value': '33.3', 'spread': '4.7', 'groupId': 'OG000'}, {'value': '23.8', 'spread': '3.2', 'groupId': 'OG001'}]}]}, {'title': 'BDK 50.0', 'categories': [{'measurements': [{'value': '53.5', 'spread': '7.6', 'groupId': 'OG000'}, {'value': '33.4', 'spread': '4.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 't-PA release will be measured during Phase 1 at the participants visit 3 which is ~3 weeks from their respective start date.', 'description': 'Net endothelial release of t-PA antigen in response to BDK was calculated using the following equation:\n\nNet release = (Cv-Ca) x (FBF x \\[101-hematocrit/100\\]) where Cv and Ca represent the concentration in the vein and artery respectively. A positive difference indicated a net release and a negative difference, net uptake. Arterial and venous blood samples were collected simultaneously at the end of saline and each dose of BDK (12.5, 25.0 and 50.0 ng/100mL tissue/min). Enzyme immunoassay was used to determine t-PA antigen concentrations. Hematocrit was measured in triplicate using the standard microhematocrit technique and corrected for trapped plasma volume within the red blood cells.', 'unitOfMeasure': 'ng/100 mL tissue/min', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed is different than reported in the participant flow module due to the availability of BDK during the clinical trial.'}, {'type': 'PRIMARY', 'title': 'Phase 2: Endothelial t-PA Release in Response to Bradykinin (BDK)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2 Before Sleep Intervention', 'description': 'Phase 2 is an intervention study to determine the effects of individualized targeted sleep interventions that increase sleep duration and improve sleep quality on endothelial vasodilator and fibrinolytic function in ART-treated HIV-1-seropositive adults who habitually sleep less than 7 hours/night.'}, {'id': 'OG001', 'title': 'Phase 2 After Sleep Intervention', 'description': 'Phase 2 is an intervention study to determine the effects of individualized targeted sleep interventions that increase sleep duration and improve sleep quality on endothelial vasodilator and fibrinolytic function in ART-treated HIV-1-seropositive adults who habitually sleep less than 7 hours/night.\n\nIndividualized Targeted Sleep: The investigators will employ an 8-week individualized targeted sleep intervention. Individualized targeted interventions have the advantage of improving adherence, reducing attrition, and making the strategy personally meaningful.'}], 'classes': [{'title': 'Saline', 'categories': [{'measurements': [{'value': '-1.8', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '-2.1', 'spread': '2.5', 'groupId': 'OG001'}]}]}, {'title': 'BDK 12.5', 'categories': [{'measurements': [{'value': '15.1', 'spread': '7.1', 'groupId': 'OG000'}, {'value': '25.4', 'spread': '5.8', 'groupId': 'OG001'}]}]}, {'title': 'BDK 25.0', 'categories': [{'measurements': [{'value': '20.6', 'spread': '6.3', 'groupId': 'OG000'}, {'value': '50.1', 'spread': '14.6', 'groupId': 'OG001'}]}]}, {'title': 'BDK 50.0', 'categories': [{'measurements': [{'value': '38.9', 'spread': '8.4', 'groupId': 'OG000'}, {'value': '78.8', 'spread': '16.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 't-PA release will be measured during Phase 2 at the participants visit 9 which is ~11 weeks from their respective start date', 'description': 'Endothelial t-PA release will me measured following the participants 8 week sleep intervention. Net endothelial release of t-PA antigen in response to BDK was calculated using the following equation:\n\nNet release = (Cv-Ca) x (FBF x \\[101-hematocrit/100\\]) where Cv and Ca represent the concentration in the vein and artery respectively. A positive difference indicated a net release and a negative difference, net uptake. Arterial and venous blood samples were collected simultaneously at the end of saline and each dose of BDK (12.5, 25.0 and 50.0 ng/100mL tissue/min). Enzyme immunoassay was used to determine t-PA antigen concentrations. Hematocrit was measured in triplicate using the standard microhematocrit technique and corrected for trapped plasma volume within the red blood cells.', 'unitOfMeasure': 'ng/100 mL tissue/min', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Phase 1: FBF Response to ACh+Ng-monomethyl-L-arginine (L-NMMA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Sleep Duration (ACh)', 'description': 'Normal Sleep Duration group slept \\>7 h/night.\n\nForearm blood flow (FBF) measured in response to Acetylcholine.'}, {'id': 'OG001', 'title': 'Normal Sleep Duration (ACh+L-NMMA)', 'description': 'Normal Sleep Duration group slept \\>7 h/night.\n\nFBF measured in response to Acetylcholine+L-NMMA.'}, {'id': 'OG002', 'title': 'Short Sleep Duration (ACh)', 'description': 'Short Sleep Duration group slept \\<7h/night.\n\nForearm blood flow (FBF) measured in response to Acetylcholine.'}, {'id': 'OG003', 'title': 'Short Sleep Duration (ACh+L-NMMA)', 'description': 'Short Sleep Duration group slept \\<7h/night.\n\nFBF measured in response to Acetylcholine+L-NMMA.'}], 'classes': [{'title': 'Saline', 'categories': [{'measurements': [{'value': '4.6', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '0.3', 'groupId': 'OG001'}, {'value': '4.2', 'spread': '0.3', 'groupId': 'OG002'}, {'value': '3.3', 'spread': '0.2', 'groupId': 'OG003'}]}]}, {'title': 'ACh 4.0', 'categories': [{'measurements': [{'value': '11.7', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '9.2', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '9.9', 'spread': '0.5', 'groupId': 'OG002'}, {'value': '8.8', 'spread': '0.5', 'groupId': 'OG003'}]}]}, {'title': 'ACh 8.0', 'categories': [{'measurements': [{'value': '12.4', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '9.9', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '10.6', 'spread': '0.6', 'groupId': 'OG002'}, {'value': '9.6', 'spread': '0.6', 'groupId': 'OG003'}]}]}, {'title': 'ACh 16.0', 'categories': [{'measurements': [{'value': '14.1', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '12.1', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '12.0', 'spread': '0.6', 'groupId': 'OG002'}, {'value': '11.1', 'spread': '0.6', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'FBF response to ACh+L-NMMA will be measured during Phase 1 at the participants visit 3 which is ~3 weeks from their respective start date.', 'description': 'To determine the contribution of nitric oxide to ACh-mediated vasodilation, FBF to ACh was quantified before and after infusion of L-NMMA. After ACh was infused as described in Outcome measure 1 the ACh dose response was repeated with the continuous infusion of L-NMMA.', 'unitOfMeasure': 'mL/100 mL tissue/min', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Phase 1: FBF Response to ACh+Vitamin C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Sleep Duration (ACh)', 'description': 'Normal Sleep Duration group slept \\>7 h/night.\n\nForearm blood flow (FBF) measured in response to Acetylcholine.'}, {'id': 'OG001', 'title': 'Normal Sleep Duration (ACh+Vitamin C)', 'description': 'Normal Sleep Duration group slept \\>7 h/night.\n\nFBF measured in response to Acetylcholine+Vitamin C.'}, {'id': 'OG002', 'title': 'Short Sleep Duration (ACh)', 'description': 'Short Sleep Duration group slept \\<7h/night.\n\nForearm blood flow (FBF) measured in response to Acetylcholine.'}, {'id': 'OG003', 'title': 'Short Sleep Duration (ACh+Vitamin C)', 'description': 'Short Sleep Duration group slept \\<7h/night.\n\nFBF measured in response to Acetylcholine+Vitamin C.'}], 'classes': [{'title': 'Saline', 'categories': [{'measurements': [{'value': '4.6', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '5.1', 'spread': '0.4', 'groupId': 'OG001'}, {'value': '4.2', 'spread': '0.3', 'groupId': 'OG002'}, {'value': '4.4', 'spread': '0.3', 'groupId': 'OG003'}]}]}, {'title': 'Ach 4.0', 'categories': [{'measurements': [{'value': '11.7', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '14.3', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '9.9', 'spread': '0.5', 'groupId': 'OG002'}, {'value': '13.3', 'spread': '0.6', 'groupId': 'OG003'}]}]}, {'title': 'Ach 8.0', 'categories': [{'measurements': [{'value': '12.4', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '15.2', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '10.5', 'spread': '0.6', 'groupId': 'OG002'}, {'value': '14.0', 'spread': '0.7', 'groupId': 'OG003'}]}]}, {'title': 'Ach 16.0', 'categories': [{'measurements': [{'value': '14.1', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '16.7', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '12.0', 'spread': '0.6', 'groupId': 'OG002'}, {'value': '15.9', 'spread': '0.7', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'FBF response to ACh+Vitamin C will be measured during Phase 1 at the participants visit 3 which is ~3 weeks from their respective start date.', 'description': 'After allowing sufficient time (45 minutes) for FBF to return to levels similar to that of saline Vitamin C was infused at a constant rate (12 mg/100 mL tissue/min) for 5 minutes. This vitamin C concentration has been show to improve endothelium dependent vasodilation in conditions associated with oxidative stress. Vitamin C infusion was maintained at the same rate while the ACh dose response was repeated.', 'unitOfMeasure': 'mL/100 mL tissue/min', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Phase 2: FBF Response to ACh+L-NMMA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Short Sleep Duration (ACh) Before Intervention', 'description': 'Short Sleep Duration group slept \\<7h/night.\n\nBefore Intervention: Forearm blood flow (FBF) measured in response to Acetylcholine.'}, {'id': 'OG001', 'title': 'Short Sleep Duration (ACh+L-NMMA) Before Intervention', 'description': 'Short Sleep Duration group slept \\<7h/night.\n\nBefore Intervention: FBF measured in response to Acetylcholine+L-NMMA.'}, {'id': 'OG002', 'title': 'Short Sleep Duration (ACh) After Intervention', 'description': 'Short Sleep Duration group slept \\<7h/night.\n\nAfter Intervention: Forearm blood flow (FBF) measured in response to Acetylcholine.'}, {'id': 'OG003', 'title': 'Short Sleep Duration (ACh+L-NMMA) After Intervention', 'description': 'Short Sleep Duration group slept \\<7h/night.\n\nAfter Intervention: FBF measured in response to Acetylcholine+L-NMMA.'}], 'classes': [{'title': 'Saline', 'categories': [{'measurements': [{'value': '4.2', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '0.3', 'groupId': 'OG001'}, {'value': '4.0', 'spread': '0.3', 'groupId': 'OG002'}, {'value': '3.8', 'spread': '0.5', 'groupId': 'OG003'}]}]}, {'title': 'ACh 4.0', 'categories': [{'measurements': [{'value': '9.2', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '9.0', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '11.1', 'spread': '0.7', 'groupId': 'OG002'}, {'value': '7.6', 'spread': '0.6', 'groupId': 'OG003'}]}]}, {'title': 'ACh 8.0', 'categories': [{'measurements': [{'value': '9.9', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '9.7', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '12.2', 'spread': '0.7', 'groupId': 'OG002'}, {'value': '10.1', 'spread': '1.1', 'groupId': 'OG003'}]}]}, {'title': 'ACh 16.0', 'categories': [{'measurements': [{'value': '11.3', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '10.8', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '14.0', 'spread': '0.6', 'groupId': 'OG002'}, {'value': '10.8', 'spread': '1.0', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'FBF response to ACh+L-NMMA will be measured during Phase 2 at the participants visit 9 which is ~11 weeks from their respective start date', 'description': 'FBF to ACh+L-NMMA will me measured following the participants 8 week sleep intervention. To determine the contribution of nitric oxide to ACh-mediated vasodilation, FBF to ACh was quantified before and after infusion of L-NMMA. After ACh was infused as described in Outcome measure 1 the ACh dose response was repeated with the continuous infusion of L-NMMA.', 'unitOfMeasure': 'mL/100 mL tissue/min', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Phase 2: FBF Response to ACh+Vitamin C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Short Sleep Duration (ACh) Before Intervention', 'description': 'Short Sleep Duration group slept \\<7h/night.\n\nBefore Intervention: Forearm blood flow (FBF) measured in response to Acetylcholine.'}, {'id': 'OG001', 'title': 'Short Sleep Duration (ACh+Vitamin C) Before Intervention', 'description': 'Short Sleep Duration group slept \\<7h/night.\n\nBefore Intervention: FBF measured in response to Acetylcholine+Vitamin C.'}, {'id': 'OG002', 'title': 'Short Sleep Duration (ACh) After Intervention', 'description': 'Short Sleep Duration group slept \\<7h/night.\n\nAfter Intervention: Forearm blood flow (FBF) measured in response to Acetylcholine.'}, {'id': 'OG003', 'title': 'Short Sleep Duration (ACh+Vitamin C) After Intervention', 'description': 'Short Sleep Duration group slept \\<7h/night.\n\nAfter Intervention: FBF measured in response to Acetylcholine+Vitamin C.'}], 'classes': [{'title': 'Saline', 'categories': [{'measurements': [{'value': '4.2', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '4.3', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '4.0', 'spread': '0.3', 'groupId': 'OG002'}, {'value': '4.8', 'spread': '0.6', 'groupId': 'OG003'}]}]}, {'title': 'ACh 4.0', 'categories': [{'measurements': [{'value': '9.2', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '12.6', 'spread': '1.3', 'groupId': 'OG001'}, {'value': '11.1', 'spread': '0.7', 'groupId': 'OG002'}, {'value': '12.4', 'spread': '1.7', 'groupId': 'OG003'}]}]}, {'title': 'ACh 8.0', 'categories': [{'measurements': [{'value': '9.9', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '13.5', 'spread': '1.3', 'groupId': 'OG001'}, {'value': '12.2', 'spread': '0.7', 'groupId': 'OG002'}, {'value': '13.0', 'spread': '1.5', 'groupId': 'OG003'}]}]}, {'title': 'ACh 16.0', 'categories': [{'measurements': [{'value': '11.3', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '14.8', 'spread': '1.5', 'groupId': 'OG001'}, {'value': '14.0', 'spread': '0.6', 'groupId': 'OG002'}, {'value': '14.2', 'spread': '1.5', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'FBF response to ACh+Vitamin C will be measured during Phase 2 at the participants visit 9 which is ~11 weeks from their respective start date', 'description': 'FBF to ACh+Vitamin C will me measured following the participants 8 week sleep intervention. After allowing sufficient time (45 minutes) for FBF to return to levels similar to that of saline Vitamin C was infused at a constant rate (12 mg/100 mL tissue/min) for 5 minutes. This vitamin C concentration has been show to improve endothelium dependent vasodilation in conditions associated with oxidative stress. Vitamin C infusion was maintained at the same rate while the ACh dose response was repeated.', 'unitOfMeasure': 'mL/100 mL tissue/min', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Nightly Sleep Duration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Sleep Duration', 'description': 'Normal Sleep Duration group slept \\>7 h/night.'}, {'id': 'OG001', 'title': 'Short Sleep Duration', 'description': 'Short Sleep Duration group slept \\<7h/night.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.8', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '5.8', 'spread': '0.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Nightly sleep duration was calculated as the weighted average of weeknights and weekend values \\[(5 x weekday sleep duration)+(2 x weekend sleep duration)/7\\].', 'unitOfMeasure': 'hours/night', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Nightly sleep duration was measured during Phase 1 at the participants initial visit.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'No Intervention: Phase 1 Normal Sleep Group', 'description': 'Phase 1 is a cross-sectional study designed to compare endothelial vasodilator (forearm blood flow) and fibrinolytic function (t-PA release) in ART-treated HIV-1-seropositive adults who habitually sleep more than 7 hours/night (normal sleep) and those who habitually sleep less than 7 hours/night (short sleep).'}, {'id': 'FG001', 'title': 'No Intervention: Phase 1 Short Sleep Group', 'description': 'Phase 1 is a cross-sectional study designed to compare endothelial vasodilator (forearm blood flow) and fibrinolytic function (t-PA release) in ART-treated HIV-1-seropositive adults who habitually sleep more than 7 hours/night (normal sleep) and those who habitually sleep less than 7 hours/night (short sleep).'}, {'id': 'FG002', 'title': 'Experimental: Phase 2', 'description': 'Phase 2 is an intervention study designed to determine the effects of individualized targeted sleep interventions that increase sleep duration and improve sleep quality on endothelial vasodilator (forearm blood flow) and fibrinolytic function (t-PA release) in ART-treated HIV-1-seropositive adults who habitually sleep less than 7 hours/night.\n\n.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '42'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '33'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Based on the participants nightly sleep duration they were enrolled either in Phase 1: No Intervention: Normal Sleep Group or Phase 1: No Intervention: Short Sleep Group. 10 participants with short nightly sleep duration were recruited separately and enrolled into Phase 2. After participants sign the informed consent, they complete a blood draw and a graded exercise stress test.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '88', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'No Intervention: Phase 1 Normal Sleep Group', 'description': 'Phase 1 is a cross-sectional study designed to compare endothelial vasodilator (forearm blood flow) and fibrinolytic function (t-PA release) in ART-treated HIV-1-seropositive adults who habitually sleep more than 7 hours/night (normal sleep) and those who habitually sleep less than 7 hours/night (short sleep).'}, {'id': 'BG001', 'title': 'No Intervention: Phase 1 Short Sleep Group', 'description': 'Phase 1 is a cross-sectional study designed to compare endothelial vasodilator (forearm blood flow) and fibrinolytic function (t-PA release) in ART-treated HIV-1-seropositive adults who habitually sleep more than 7 hours/night (normal sleep) and those who habitually sleep less than 7 hours/night (short sleep).'}, {'id': 'BG002', 'title': 'Experimental: Phase 2 Sleep Intervention Study', 'description': 'Phase 2 is an intervention study designed to determine the effects of individualized targeted sleep interventions that increase sleep duration and improve sleep quality on endothelial vasodilator (forearm blood flow) and fibrinolytic function (t-PA release) in ART-treated HIV-1-seropositive adults who habitually sleep less than 7 hours/night.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '88', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '75', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '74', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '83', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '88', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'After participants sign the informed consent, they complete a blood draw and a graded exercise stress test. Based on the participants nightly sleep duration they were either in Phase 1: No Intervention: Normal Sleep Group or Phase 1: No Intervention: Short Sleep Group. 10 participants with short nightly sleep duration were recruited separately and enrolled in Phase 2. These 10 participants are only counted in the Phase 2 Sleep Intervention Study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-03-08', 'size': 325228, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-11-05T12:33', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2020-08-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-03', 'studyFirstSubmitDate': '2021-06-23', 'resultsFirstSubmitDate': '2021-11-05', 'studyFirstSubmitQcDate': '2021-06-30', 'lastUpdatePostDateStruct': {'date': '2025-01-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-12-03', 'studyFirstPostDateStruct': {'date': '2021-07-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phase 1: Forearm Blood Flow (FBF) Response to Acetylcholine (ACh)', 'timeFrame': 'FBF response to ACh will be measured during Phase 1 at the participants visit 3 which is ~3 weeks from their respective start date.', 'description': 'FBF was measured via strain-gauge venous occlusion plethysmography in response to saline for 5 minutes and then to ACh (4.0, 8.0 and 16.0 ug/100 mL tissue/min; the doses of Acetylcholine infused into the brachial artery) for 5 minutes at each dose. Flows during the last minute of saline and each drug dose were measured and the mean value reported.\n\nValues after saline and after ACh 4.0, 8.0 and 16.0 at week 3 are reported.'}, {'measure': 'Phase 2: FBF Response to Acetylcholine (ACh)', 'timeFrame': 'FBF response to ACh will be measured during Phase 2 at the participants visit 9 which is ~11 weeks from their respective start date', 'description': 'FBF to ACh will be measured following the participants 8 week sleep intervention.'}, {'measure': 'Phase 1: Forearm Blood Flow (FBF) Response to Sodium Nitroprusside (NTP)', 'timeFrame': 'FBF response to NTP will be measured during Phase 1 at the participants visit 3 which is ~3 weeks from their respective start date.'}, {'measure': 'Phase 2: Forearm Blood Flow (FBF) Response to Sodium Nitroprusside (NTP)', 'timeFrame': 'FBF response to NTP will be measured during Phase 2 at the participants visit 9 which is ~11 weeks from their respective start date', 'description': 'FBF to NTP will me measured following the participants 8 week sleep intervention'}, {'measure': 'Phase 1: Endothelial Tissue Type Plasminogen Activator (t-PA) Release in Response to Bradykinin (BDK)', 'timeFrame': 't-PA release will be measured during Phase 1 at the participants visit 3 which is ~3 weeks from their respective start date.', 'description': 'Net endothelial release of t-PA antigen in response to BDK was calculated using the following equation:\n\nNet release = (Cv-Ca) x (FBF x \\[101-hematocrit/100\\]) where Cv and Ca represent the concentration in the vein and artery respectively. A positive difference indicated a net release and a negative difference, net uptake. Arterial and venous blood samples were collected simultaneously at the end of saline and each dose of BDK (12.5, 25.0 and 50.0 ng/100mL tissue/min). Enzyme immunoassay was used to determine t-PA antigen concentrations. Hematocrit was measured in triplicate using the standard microhematocrit technique and corrected for trapped plasma volume within the red blood cells.'}, {'measure': 'Phase 2: Endothelial t-PA Release in Response to Bradykinin (BDK)', 'timeFrame': 't-PA release will be measured during Phase 2 at the participants visit 9 which is ~11 weeks from their respective start date', 'description': 'Endothelial t-PA release will me measured following the participants 8 week sleep intervention. Net endothelial release of t-PA antigen in response to BDK was calculated using the following equation:\n\nNet release = (Cv-Ca) x (FBF x \\[101-hematocrit/100\\]) where Cv and Ca represent the concentration in the vein and artery respectively. A positive difference indicated a net release and a negative difference, net uptake. Arterial and venous blood samples were collected simultaneously at the end of saline and each dose of BDK (12.5, 25.0 and 50.0 ng/100mL tissue/min). Enzyme immunoassay was used to determine t-PA antigen concentrations. Hematocrit was measured in triplicate using the standard microhematocrit technique and corrected for trapped plasma volume within the red blood cells.'}, {'measure': 'Phase 1: FBF Response to ACh+Ng-monomethyl-L-arginine (L-NMMA)', 'timeFrame': 'FBF response to ACh+L-NMMA will be measured during Phase 1 at the participants visit 3 which is ~3 weeks from their respective start date.', 'description': 'To determine the contribution of nitric oxide to ACh-mediated vasodilation, FBF to ACh was quantified before and after infusion of L-NMMA. After ACh was infused as described in Outcome measure 1 the ACh dose response was repeated with the continuous infusion of L-NMMA.'}, {'measure': 'Phase 1: FBF Response to ACh+Vitamin C', 'timeFrame': 'FBF response to ACh+Vitamin C will be measured during Phase 1 at the participants visit 3 which is ~3 weeks from their respective start date.', 'description': 'After allowing sufficient time (45 minutes) for FBF to return to levels similar to that of saline Vitamin C was infused at a constant rate (12 mg/100 mL tissue/min) for 5 minutes. This vitamin C concentration has been show to improve endothelium dependent vasodilation in conditions associated with oxidative stress. Vitamin C infusion was maintained at the same rate while the ACh dose response was repeated.'}, {'measure': 'Phase 2: FBF Response to ACh+L-NMMA', 'timeFrame': 'FBF response to ACh+L-NMMA will be measured during Phase 2 at the participants visit 9 which is ~11 weeks from their respective start date', 'description': 'FBF to ACh+L-NMMA will me measured following the participants 8 week sleep intervention. To determine the contribution of nitric oxide to ACh-mediated vasodilation, FBF to ACh was quantified before and after infusion of L-NMMA. After ACh was infused as described in Outcome measure 1 the ACh dose response was repeated with the continuous infusion of L-NMMA.'}, {'measure': 'Phase 2: FBF Response to ACh+Vitamin C', 'timeFrame': 'FBF response to ACh+Vitamin C will be measured during Phase 2 at the participants visit 9 which is ~11 weeks from their respective start date', 'description': 'FBF to ACh+Vitamin C will me measured following the participants 8 week sleep intervention. After allowing sufficient time (45 minutes) for FBF to return to levels similar to that of saline Vitamin C was infused at a constant rate (12 mg/100 mL tissue/min) for 5 minutes. This vitamin C concentration has been show to improve endothelium dependent vasodilation in conditions associated with oxidative stress. Vitamin C infusion was maintained at the same rate while the ACh dose response was repeated.'}], 'secondaryOutcomes': [{'measure': 'Nightly Sleep Duration', 'timeFrame': 'Baseline', 'description': 'Nightly sleep duration was calculated as the weighted average of weeknights and weekend values \\[(5 x weekday sleep duration)+(2 x weekend sleep duration)/7\\].'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sleep'], 'conditions': ['HIV-1']}, 'descriptionModule': {'briefSummary': 'The investigators hypothesize that chronic insufficient sleep is associated with diminished endothelium-dependent nitric oxide-mediated vasodilation and tissue-type plasminogen activator release in anti-retroviral (ART)-treated HIV-1-seropositive adults. Furthermore, the investigators hypothesize that the postulated diminishment in endothelial vasodilator and fibrinolytic function with insufficient sleep will be due, at least in part, to increased oxidative stress. Moreover, increasing sleep duration and improving sleep quality will increase both endothelium-dependent nitric oxide-mediated vasodilation and endothelial tissue-type plasminogen activator release in ART-treated HIV-1-seropositive adults. Increases in endothelial vasodilator and fibrinolytic function will be due, at least in part, to reduced oxidative stress.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects will be men and women of all races and ethnic backgrounds aged 40-75 years with documented HIV-1 infection.\n* Subjects will be HIV-1-seropositive individuals on a stable DHHS approved ART regimen for at least 6 months, with documented virologic suppression (\\<50 copies HIV-1 RNA/mL) for at least 3 months.\n* All subjects must have CD4+ T cell counts \\>200 cells/mm3 at the time of study entry.\n* Subjects will be free of overt CVD as assessed by: a) medical history; b) physical examination; c) electrocardiogram and BP at rest and maximal exercise; d) complete blood chemistries, lipid and lipoprotein, glucose, insulin and hematological evaluation.\n* All candidates will be sedentary as determined from the Stanford Physical Activity Questionnaire (\\<35 kcal/wk) and will not have engaged in any program of regular physical activity for at least 6 months prior to the study.\n\nExclusion Criteria:\n\n* Receiving hormone replacement therapy (HRT) currently or in the preceding 3-year period.\n* Pre- or peri-menopausal women'}, 'identificationModule': {'nctId': 'NCT04956861', 'briefTitle': 'HIV-1, Insufficient Sleep and Vascular Endothelial Dysfunction', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Boulder'}, 'officialTitle': 'HIV-1, Insufficient Sleep and Vascular Endothelial Dysfunction', 'orgStudyIdInfo': {'id': '150465'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Phase 1', 'description': 'Phase 1 is a cross-sectional study to compare endothelial vasodilator and fibrinolytic function in ART-treated HIV-1-seropositive adults who habitually sleep more than 7 hours/night (normal sleep) and those who habitually sleep less than 7 hours/night (short sleep).'}, {'type': 'EXPERIMENTAL', 'label': 'Phase 2', 'description': 'Phase 2 is an intervention study to determine the effects of individualized targeted sleep interventions that increase sleep duration and improve sleep quality on endothelial vasodilator and fibrinolytic function in ART-treated HIV-1-seropositive adults who habitually sleep less than 7 hours/night.', 'interventionNames': ['Behavioral: Individualized Targeted Sleep']}], 'interventions': [{'name': 'Individualized Targeted Sleep', 'type': 'BEHAVIORAL', 'description': 'The investigators will employ an 8-week individualized targeted sleep intervention. Individualized targeted interventions have the advantage of improving adherence, reducing attrition, and making the strategy personally meaningful.', 'armGroupLabels': ['Phase 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80309', 'city': 'Boulder', 'state': 'Colorado', 'country': 'United States', 'facility': 'UC-Boulder Clinical and Translational Research Center', 'geoPoint': {'lat': 40.01499, 'lon': -105.27055}}], 'overallOfficials': [{'name': 'Christopher DeSouza, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Boulder'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Boulder', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Christopher DeSouza', 'investigatorAffiliation': 'University of Colorado, Boulder'}}}}