Clinical trial NCT02202811: Circadian Rhythms and Cardiovascular Risk
Official title: Circadian Rhythms and Cardiovascular Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2014-07-29
Enrollment: 39
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to understand how behaviors and the effects of the body's internal clock (called the circadian pacemaker) affect the control of the heart and blood pressure.

People with Obstructive Sleep Apnea (OSA) are hypothesized to have altered circadian amplitudes in certain key indices of cardiovascular (CV) and an abnormally advanced circadian phase in some of the same key indices of CV risk. The investigators hypothesize that such changes, taken together, may explain the different timing of heart attack and sudden cardiac death in OSA.


Eligibility criteria: * BMI less than 40
* Moderate to severe OSA (AHI)\>15
* No current or previous pharmacological treatment for hypertension

Primary outcomes:
measure: Primary dependent variable: Circadian rhythm amplitude of plasma epinephrine concentration
timeFrame: Over 5 days
measure: Primary dependent variable: Circadian rhythm phase of plasma epinephrine concentration
timeFrame: Over 5 days
measure: Primary dependent variable: Circadian rhythm amplitude of plasma epinephrine reactivity to exercise
timeFrame: Over 5 days
measure: Primary dependent variable: Circadian rhythm phase of plasma epinephrine reactivity to exercise
timeFrame: Over 5 days
measure: Primary dependent variable: Circadian rhythm amplitude of plasma epinephrine reactivity to change in posture
timeFrame: Over 5 days
measure: Primary dependent variable: Circadian rhythm phase of plasma epinephrine reactivity to change in posture
timeFrame: Over 5 days
measure: Primary dependent variable: Circadian rhythm amplitude of blood pressure (BP)
timeFrame: Over 5 days
measure: Primary dependent variable: Circadian rhythm phase of blood pressure (BP)
timeFrame: Over 5 days
measure: Primary dependent variable: Circadian rhythm amplitude of blood pressure (BP) reactivity to exercise
timeFrame: Over 5 days
measure: Primary dependent variable: Circadian rhythm phase of blood pressure (BP) reactivity to exercise
timeFrame: Over 5 days
measure: Primary dependent variable: Circadian rhythm amplitude of blood pressure (BP) reactivity to change in posture
timeFrame: Over 5 days
measure: Primary dependent variable: Circadian rhythm phase of blood pressure (BP) reactivity to change in posture
timeFrame: Over 5 days
measure: Primary dependent variable: Circadian rhythm amplitude of plasma cortisol concentration
timeFrame: Over 5 days
measure: Primary dependent variable: Circadian rhythm phase of plasma cortisol concentration
timeFrame: Over 5 days
measure: Primary dependent variable: Circadian rhythm amplitude of plasma cortisol reactivity to exercise
timeFrame: Over 5 days
measure: Primary dependent variable: Circadian rhythm phase of plasma cortisol reactivity to exercise
timeFrame: Over 5 days
measure: Primary dependent variable: Circadian rhythm amplitude of plasma cortisol reactivity to change in posture
timeFrame: Over 5 days
measure: Primary dependent variable: Circadian rhythm phase of plasma cortisol reactivity to change in posture
timeFrame: Over 5 days
measure: Primary dependent variable: Circadian rhythm amplitude of heart rate
timeFrame: Over 5 days
measure: Primary dependent variable: Circadian rhythm phase of heart rate
timeFrame: Over 5 days
measure: Primary dependent variable: Circadian rhythm amplitude of heart rate reactivity to exercise
timeFrame: Over 5 days
measure: Primary dependent variable: Circadian rhythm phase of heart rate reactivity to exercise
timeFrame: Over 5 days
measure: Primary dependent variable: Circadian rhythm amplitude of heart rate reactivity to change in posture
timeFrame: Over 5 days
measure: Primary dependent variable: Circadian rhythm phase of heart rate reactivity to change in posture
timeFrame: Over 5 days
measure: Primary dependent variable: Circadian rhythm amplitude of cardiac vagal tone
timeFrame: Over 5 days
measure: Primary dependent variable: Circadian rhythm phase of cardiac vagal tone
timeFrame: Over 5 days
measure: Primary dependent variable: Circadian rhythm amplitude of cardiac vagal tone reactivity to exercise
timeFrame: Over 5 days
measure: Primary dependent variable: Circadian rhythm phase of cardiac vagal tone reactivity to exercise
timeFrame: Over 5 days
measure: Primary dependent variable: Circadian rhythm amplitude of cardiac vagal tone reactivity to change in posture
timeFrame: Over 5 days
measure: Primary dependent variable: Circadian rhythm phase of cardiac vagal tone reactivity to change in posture
timeFrame: Over 5 days
Secondary outcomes:
measure: Secondary dependent variable: Circadian rhythm amplitude of plasma tissue plasminogen activator inhibitor (tPA) concentration
timeFrame: Over 5 days
measure: Secondary dependent variable: Circadian rhythm phase of plasma tPA concentration
timeFrame: Over 5 days
measure: Secondary dependent variable: Circadian rhythm amplitude of plasma tPA reactivity to exercise
timeFrame: Over 5 days
measure: Secondary dependent variable: Circadian rhythm phase of plasma tPA reactivity to exercise
timeFrame: Over 5 days
measure: Secondary dependent variable: Circadian rhythm amplitude of plasma tPA reactivity to change in posture
timeFrame: Over 5 days
measure: Secondary dependent variable: Circadian rhythm phase of plasma tPA reactivity to change in posture
timeFrame: Over 5 days
measure: Secondary dependent variable: Circadian rhythm amplitude of vascular endothelial function
timeFrame: Over 5 days
measure: Secondary dependent variable: Circadian rhythm phase of vascular endothelial function
timeFrame: Over 5 days
measure: Secondary dependent variable: Circadian rhythm amplitude of vascular endothelial function reactivity to exercise
timeFrame: Over 5 days
measure: Secondary dependent variable: Circadian rhythm phase of vascular endothelial function reactivity to exercise
timeFrame: Over 5 days
measure: Secondary dependent variable: Circadian rhythm amplitude of vascular endothelial function reactivity to change in posture
timeFrame: Over 5 days
measure: Secondary dependent variable: Circadian rhythm phase of vascular endothelial function reactivity to change in posture
timeFrame: Over 5 days
measure: Secondary dependent variable: Circadian rhythm amplitude of plasma plasminogen activator inhibitor 1 (PAI-1) concentration
timeFrame: Over 5 days
measure: Secondary dependent variable: Circadian rhythm phase of plasma PAI-1 concentration
timeFrame: Over 5 days
measure: Secondary dependent variable: Circadian rhythm amplitude of plasma PAI-1 reactivity to exercise
timeFrame: Over 5 days
measure: Secondary dependent variable: Circadian rhythm phase of plasma PAI-1 concentration reactivity to exercise
timeFrame: Over 5 days
measure: Secondary dependent variable: Circadian rhythm amplitude of plasma PAI-1 reactivity to change in posture
timeFrame: Over 5 days
measure: Secondary dependent variable: Circadian rhythm phase of plasma PAI-1 reactivity to change in posture
timeFrame: Over 5 days
measure: Secondary dependent variable: Circadian rhythm amplitude of plasma MDA concentration
timeFrame: Over 5 days
measure: Secondary dependent variable: Circadian rhythm phase of plasma MDA concentration
timeFrame: Over 5 days
measure: Secondary dependent variable: Circadian rhythm amplitude of plasma MDA reactivity to exercise
timeFrame: Over 5 days
measure: Secondary dependent variable: Circadian rhythm phase of plasma malondialdehyde (MDA) reactivity to exercise
timeFrame: Over 5 days
measure: Secondary dependent variable: Circadian rhythm amplitude of plasma MDA concentration reactivity to change in posture
timeFrame: Over 5 days
measure: Secondary dependent variable: Circadian rhythm phase of plasma malondialdehyde (MDA) reactivity to change in posture
timeFrame: Over 5 days
measure: Secondary dependent variable: Circadian rhythm amplitude of plasma 8-isoprostane concentration
timeFrame: Over 5 days
measure: Secondary dependent variable: Circadian rhythm phase of plasma 8-isoprostane concentration
timeFrame: Over 5 days
measure: Secondary dependent variable: Circadian rhythm amplitude of plasma 8-isoprostane reactivity to exercise
timeFrame: Over 5 days
measure: Secondary dependent variable: Circadian rhythm phase of plasma 8-isoprostane reactivity to exercise
timeFrame: Over 5 days
measure: Secondary dependent variable: Circadian rhythm amplitude of plasma 8-isoprostane reactivity to change in posture
timeFrame: Over 5 days
measure: Secondary dependent variable: Circadian rhythm phase of plasma 8-isoprostane reactivity to change in posture
timeFrame: Over 5 days
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Steven A Shea, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thosar SS, Berman AM, Herzig MX, McHill AW, Bowles NP, Swanson CM, Clemons NA, Butler MP, Clemons AA, Emens JS, Shea SA. Circadian Rhythm of Vascular Function in Midlife Adults. Arterioscler Thromb Vasc Biol. 2019 Jun;39(6):1203-1211. doi: 10.1161/ATVBAHA.119.312682.