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Clinical Trials/NCT02202811
NCT02202811
Completed
Not Applicable

Circadian Rhythms and Cardiovascular Risk

Oregon Health and Science University1 site in 1 country39 target enrollmentAugust 1, 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obstructive Sleep Apnea
Sponsor
Oregon Health and Science University
Enrollment
39
Locations
1
Primary Endpoint
Primary dependent variable: Circadian rhythm phase of plasma epinephrine concentration
Status
Completed
Last Updated
10 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2014
End Date
March 9, 2020
Last Updated
10 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Saurabh Thosar

Saurabh S. Thosar, PhD

Oregon Health and Science University

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Primary dependent variable: Circadian rhythm phase of plasma epinephrine concentration

Time Frame: Over 5 days

Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian phase of plasma epinephrine concentration during resting baseline conditions. Circadian rhythm phase will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases and stated in relation to the reported habitual sleep time.

Primary dependent variable: Circadian rhythm amplitude of plasma epinephrine concentration

Time Frame: Over 5 days

Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of plasma epinephrine concentration during resting baseline conditions. Circadian rhythm amplitude will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases.

Primary dependent variable: Circadian rhythm phase of plasma epinephrine reactivity to exercise

Time Frame: Over 5 days

Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma epinephrine concentration from resting baseline to end of 15 minute of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.

Primary dependent variable: Circadian rhythm phase of heart rate

Time Frame: Over 5 days

Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian phase of heart rate during resting baseline conditions. Circadian rhythm phase will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases and stated in relation to the reported habitual sleep time.

Primary dependent variable: Circadian rhythm amplitude of plasma epinephrine reactivity to exercise

Time Frame: Over 5 days

Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma epinephrine concentration from resting baseline to end of 15 minutes of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.

Primary dependent variable: Circadian rhythm phase of blood pressure (BP)

Time Frame: Over 5 days

Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian phase of systolic and diastolic BP during resting baseline conditions. Circadian rhythm phase will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases and stated in relation to the reported habitual sleep time.

Primary dependent variable: Circadian rhythm phase of plasma cortisol reactivity to exercise

Time Frame: Over 5 days

Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma cortisol concentration from resting baseline to end of 15 minute of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.

Primary dependent variable: Circadian rhythm phase of heart rate reactivity to exercise

Time Frame: Over 5 days

Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in heart rate from resting baseline to end of 15 minute of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.

Primary dependent variable: Circadian rhythm phase of cardiac vagal tone reactivity to exercise

Time Frame: Over 5 days

Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in cardiac vagal tone from resting baseline to end of 15 minute of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.

Primary dependent variable: Circadian rhythm amplitude of plasma epinephrine reactivity to change in posture

Time Frame: Over 5 days

Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma epinephrine concentration from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.

Primary dependent variable: Circadian rhythm phase of plasma epinephrine reactivity to change in posture

Time Frame: Over 5 days

Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma epinephrine concentration from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.

Primary dependent variable: Circadian rhythm amplitude of blood pressure (BP) reactivity to exercise

Time Frame: Over 5 days

Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in systolic and diastolic BP from resting baseline to end of 15 minutes of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.

Primary dependent variable: Circadian rhythm phase of blood pressure (BP) reactivity to change in posture

Time Frame: Over 5 days

Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in systolic and diastolic BP from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.

Primary dependent variable: Circadian rhythm amplitude of blood pressure (BP)

Time Frame: Over 5 days

Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of systolic and diastolic BP during resting baseline conditions. Circadian rhythm amplitude will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases.

Primary dependent variable: Circadian rhythm amplitude of blood pressure (BP) reactivity to change in posture

Time Frame: Over 5 days

Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in systolic and diastolic BP from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.

Primary dependent variable: Circadian rhythm phase of plasma cortisol reactivity to change in posture

Time Frame: Over 5 days

Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma cortisol concentration from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.

Primary dependent variable: Circadian rhythm phase of heart rate reactivity to change in posture

Time Frame: Over 5 days

Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in heart rate from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.

Primary dependent variable: Circadian rhythm phase of blood pressure (BP) reactivity to exercise

Time Frame: Over 5 days

Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in systolic and diastolic BP from resting baseline to end of 15 minute of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.

Primary dependent variable: Circadian rhythm amplitude of plasma cortisol concentration

Time Frame: Over 5 days

Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of plasma cortisol concentration during resting baseline conditions. Circadian rhythm amplitude will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases.

Primary dependent variable: Circadian rhythm phase of plasma cortisol concentration

Time Frame: Over 5 days

Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian phase of plasma cortisol concentration during resting baseline conditions. Circadian rhythm phase will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases and stated in relation to the reported habitual sleep time.

Primary dependent variable: Circadian rhythm amplitude of plasma cortisol reactivity to exercise

Time Frame: Over 5 days

Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma cortisol concentration from resting baseline to end of 15 minutes of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.

Primary dependent variable: Circadian rhythm amplitude of plasma cortisol reactivity to change in posture

Time Frame: Over 5 days

Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma cortisol concentration from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.

Primary dependent variable: Circadian rhythm amplitude of heart rate

Time Frame: Over 5 days

Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of heart rate during resting baseline conditions. Circadian rhythm amplitude will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases.

Primary dependent variable: Circadian rhythm amplitude of heart rate reactivity to exercise

Time Frame: Over 5 days

Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in heart rate from resting baseline to end of 15 minutes of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.

Primary dependent variable: Circadian rhythm amplitude of cardiac vagal tone

Time Frame: Over 5 days

Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of cardiac vagal tone during resting baseline conditions. Circadian rhythm amplitude will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases.

Primary dependent variable: Circadian rhythm amplitude of cardiac vagal tone reactivity to exercise

Time Frame: Over 5 days

Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in cardiac vagal tone from resting baseline to end of 15 minutes of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.

Primary dependent variable: Circadian rhythm amplitude of heart rate reactivity to change in posture

Time Frame: Over 5 days

Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in heart rate from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.

Primary dependent variable: Circadian rhythm phase of cardiac vagal tone

Time Frame: Over 5 days

Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian phase of cardiac vagal tone during resting baseline conditions. Circadian rhythm phase will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases and stated in relation to the reported habitual sleep time.

Primary dependent variable: Circadian rhythm amplitude of cardiac vagal tone reactivity to change in posture

Time Frame: Over 5 days

Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in cardiac vagal tone from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.

Primary dependent variable: Circadian rhythm phase of cardiac vagal tone reactivity to change in posture

Time Frame: Over 5 days

Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in cardiac vagal tone from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.

Secondary Outcomes

  • Secondary dependent variable: Circadian rhythm amplitude of plasma MDA reactivity to exercise(Over 5 days)
  • Secondary dependent variable: Circadian rhythm amplitude of plasma tPA reactivity to change in posture(Over 5 days)
  • Secondary dependent variable: Circadian rhythm amplitude of vascular endothelial function(Over 5 days)
  • Secondary dependent variable: Circadian rhythm amplitude of plasma PAI-1 reactivity to change in posture(Over 5 days)
  • Secondary dependent variable: Circadian rhythm phase of plasma MDA concentration(Over 5 days)
  • Secondary dependent variable: Circadian rhythm phase of vascular endothelial function(Over 5 days)
  • Secondary dependent variable: Circadian rhythm phase of vascular endothelial function reactivity to exercise(Over 5 days)
  • Secondary dependent variable: Circadian rhythm amplitude of plasma plasminogen activator inhibitor 1 (PAI-1) concentration(Over 5 days)
  • Secondary dependent variable: Circadian rhythm amplitude of plasma PAI-1 reactivity to exercise(Over 5 days)
  • Secondary dependent variable: Circadian rhythm amplitude of plasma MDA concentration(Over 5 days)
  • Secondary dependent variable: Circadian rhythm phase of plasma malondialdehyde (MDA) reactivity to exercise(Over 5 days)
  • Secondary dependent variable: Circadian rhythm phase of plasma 8-isoprostane reactivity to change in posture(Over 5 days)
  • Secondary dependent variable: Circadian rhythm amplitude of plasma tPA reactivity to exercise(Over 5 days)
  • Secondary dependent variable: Circadian rhythm phase of plasma tPA reactivity to exercise(Over 5 days)
  • Secondary dependent variable: Circadian rhythm phase of plasma PAI-1 concentration reactivity to exercise(Over 5 days)
  • Secondary dependent variable: Circadian rhythm phase of plasma PAI-1 reactivity to change in posture(Over 5 days)
  • Secondary dependent variable: Circadian rhythm amplitude of plasma MDA concentration reactivity to change in posture(Over 5 days)
  • Secondary dependent variable: Circadian rhythm phase of plasma malondialdehyde (MDA) reactivity to change in posture(Over 5 days)
  • Secondary dependent variable: Circadian rhythm amplitude of plasma 8-isoprostane concentration(Over 5 days)
  • Secondary dependent variable: Circadian rhythm amplitude of plasma 8-isoprostane reactivity to change in posture(Over 5 days)
  • Secondary dependent variable: Circadian rhythm amplitude of plasma tissue plasminogen activator inhibitor (tPA) concentration(Over 5 days)
  • Secondary dependent variable: Circadian rhythm phase of plasma tPA concentration(Over 5 days)
  • Secondary dependent variable: Circadian rhythm phase of plasma tPA reactivity to change in posture(Over 5 days)
  • Secondary dependent variable: Circadian rhythm amplitude of vascular endothelial function reactivity to exercise(Over 5 days)
  • Secondary dependent variable: Circadian rhythm amplitude of vascular endothelial function reactivity to change in posture(Over 5 days)
  • Secondary dependent variable: Circadian rhythm phase of vascular endothelial function reactivity to change in posture(Over 5 days)
  • Secondary dependent variable: Circadian rhythm phase of plasma PAI-1 concentration(Over 5 days)
  • Secondary dependent variable: Circadian rhythm phase of plasma 8-isoprostane concentration(Over 5 days)
  • Secondary dependent variable: Circadian rhythm phase of plasma 8-isoprostane reactivity to exercise(Over 5 days)
  • Secondary dependent variable: Circadian rhythm amplitude of plasma 8-isoprostane reactivity to exercise(Over 5 days)

Study Sites (1)

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