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出境医 / 临床实验 / Sleep Quality and Mechanisms of Cardiovascular Risks in Adults With Hypertension

Sleep Quality and Mechanisms of Cardiovascular Risks in Adults With Hypertension

Study Description
Brief Summary:
The objective of this study is to elucidate the potential mechanisms responsible for the increased risk of cardiovascular disease among patients with hypertension and comorbid insomnia.

Condition or disease Intervention/treatment Phase
Hypertension Insomnia Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I) Not Applicable

Detailed Description:
The investigators propose to utilize a behavioral intervention to manipulate sleep quality in 150 adults with hypertension and comorbid insomnia, who will receive a 6-week Cognitive Behavioral therapy for Insomnia (CBT-I) intervention, which has been shown to markedly improve sleep quality and promote consolidated sleep in approximately 60% of those treated. A lowering of nighttime blood pressure is one of several proposed mechanisms to be examined.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: All participants will receive the Cognitive Behavioral Therapy for Insomnia
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Sleep Quality and Mechanisms of Cardiovascular Risks in Adults With Hypertension
Actual Study Start Date : February 14, 2020
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : June 2024
Arms and Interventions
Arm Intervention/treatment
Cognitive Behavioral Therapy for Insomnia
Cognitive Behavioral Therapy for Insomnia (CBT-I) 6 sessions of Cognitive Behavioral Training for Insomnia (1 hour each).
 Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)
6-week CBT-I therapy to help improve sleep quality
Outcome Measures
Primary Outcome Measures :
  1. Change in blood pressure during the nighttime sleep period [ Time Frame: Baseline, 6 week, 12 week, 6 month ]
    Average nighttime blood pressure (mm Hg) measured by 24 hour ambulatory blood pressure monitoring before and after CBT-I

  2. Change in sleep during the nighttime sleep period [ Time Frame: Baseline, 6 week, 12 week, 6 month ]
    Sleep efficiency (percent-time asleep during the sleep period) measured by sleep diary and actigraphy before and after CBT-I.

  3. Changes in insomnia severity [ Time Frame: Baseline, 6 week, 12 week, 6 month ]
    Insomnia measured by the Insomnia Severity Index before and after CBT-I.


Secondary Outcome Measures :
  1. Change in awake blood pressure [ Time Frame: Baseline, 6 week, 12 week, 6 month ]
    Average awake blood pressure (mm Hg) measured by 24 hour ambulatory blood pressure monitoring before and after CBT-I

  2. Change in nighttime blood pressure dipping [ Time Frame: Baseline, 6 week, 12 week, 6 month ]
    Average percent change in blood pressure (mm Hg) from awake to nighttime measured by 24 hour ambulatory blood pressure monitoring before and after CBT-I

  3. Change in vascular endothelial function [ Time Frame: Baseline, 6 week, 12 week, 6 month ]
    Percent dilation of the brachial artery to reactive hyperemia measured by flow mediated dilation before and after CBT-I

  4. Change in arterial stiffness [ Time Frame: 6 week, 6 month ]
    Pulse wave velocity (m/s) of the descending aorta measured using the Complior system before and after CBT-I

  5. Change in lipid profile [ Time Frame: Baseline, 6 week, 12 week, 6 month ]
    Lipids (Total, HDL, LDL, Cholesterol and Triglycerides) from fasting venous blood draw measured before and after CBT-I

  6. Change in nighttime sympathetic nervous system activity [ Time Frame: 6 week, 12 week ]
    Measured by 24 hour urine collection (awake and sleep period collection separated) assayed for catecholamines (epinephrine, norepinephrine) and creatinine before and after CBT-I

  7. Change in cardiac structure [ Time Frame: 6 week, 6 month ]
    Cardiac left ventricular mass (g m^-2.7) before and after CBT-I

  8. Change in cardiac function [ Time Frame: 6 week, 6 month ]
    Cardiac left ventricular strain (%) before and after CBT-I

  9. Change in sleep fragmentation during the nighttime sleep period [ Time Frame: Baseline, 6 week, 12 week, 6 month ]
    Sleep Fragmentation Index measured by actigraphy before and after CBT-I.

  10. Change in subjective sleep quality [ Time Frame: Baseline, 6 week, 12 week, 6 month ]
    Subjective Sleep Quality measured by Pittsburgh Sleep Quality Index before and after CBT-I.

  11. Change in Office Blood Pressure [ Time Frame: Baseline, 6 week, 12 week, 6 month ]
    Average office seated blood pressure taken by automated clinic blood pressure monitor after 5 minutes rest and based on the average of 3 readings taken at one minute intervals (mm Hg)


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Systolic BP ≥ 130 mm Hg based upon two standardized BP screening assessments
  • A current diagnosis of insomnia disorder as defined in the International Classification of Sleep Disorders (ICSD-3); or undiagnosed, but suspected, insomnia disorder that is confirmed at their screening lab visit

Exclusion Criteria:

  • Uncontrolled hypertension (screening office BP > 160/100 mm Hg)
  • Antihypertensive medication use
  • Cardiovascular medications
  • Previously diagnosed moderate or severe obstructive sleep apnea
  • Severe obesity defined by BMI>40 kg/m2
  • Pacemakers
  • Atrial fibrillation
  • Acute coronary syndrome or coronary revascularization procedure within 6 months of enrollment
  • Congestive heart failure
  • Identifiable cause of hypertension (e.g., primary hyperaldosteronism, renal artery stenosis, untreated hyper- or hypothyroidism, chronic kidney disease, Cushing's disease, pheochromocytoma, coarctation of the aorta)
  • Severe uncorrected valvular heart disease
  • Current pregnancy
  • Active diagnosis of psychosis, bipolar disorder
  • Diabetes
  • Severely impaired hearing or speech
  • Participation in another interventional study to address insomnia
  • Rotating shift workers
  • Prominent suicidal or homicidal ideation (as assessed through a clinical interview)
  • Psychiatric Hospitalization within the past 12 months
  • Alcohol or drug abuse within 12 months
  • Exposure-based PTSD treatment
  • Dementia
  • Unstable comorbid sleep disorder requiring assessment and/or treatment outside of the study protocol
  • Medical or psychiatric conditions judged to be the primary cause of insomnia
  • Inability to comply with the assessment procedures or inability to provide informed consent.
Contacts and Locations

Contacts
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Contact: Kristy Johnson, MPH 919-681-5874 johns121@mc.duke.edu
Contact: Andrew Sherwood, PhD 919-684-8835 sherw002@mc.duke.edu

Locations
Layout table for location information
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Principal Investigator: Andrew Sherwood, PhD         
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Kristy S Johnson, MPH    919-681-5874    johns121@mc.duke.edu   
Contact: Andrew Sherwood, PhD    919-684-8835    sherw002@mc.duke.edu   
Principal Investigator: Andrew Sherwood, PhD         
Sponsors and Collaborators
Duke University
National Institutes of Health (NIH)
Investigators
Layout table for investigator information
Principal Investigator: Andrew Sherwood, PhD Duke University
Tracking Information
First Submitted Date  ICMJE July 3, 2019
First Posted Date  ICMJE July 5, 2019
Last Update Posted Date March 10, 2021
Actual Study Start Date  ICMJE February 14, 2020
Estimated Primary Completion Date June 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 10, 2020)
  • Change in blood pressure during the nighttime sleep period [ Time Frame: Baseline, 6 week, 12 week, 6 month ]
    Average nighttime blood pressure (mm Hg) measured by 24 hour ambulatory blood pressure monitoring before and after CBT-I
  • Change in sleep during the nighttime sleep period [ Time Frame: Baseline, 6 week, 12 week, 6 month ]
    Sleep efficiency (percent-time asleep during the sleep period) measured by sleep diary and actigraphy before and after CBT-I.
  • Changes in insomnia severity [ Time Frame: Baseline, 6 week, 12 week, 6 month ]
    Insomnia measured by the Insomnia Severity Index before and after CBT-I.
Original Primary Outcome Measures  ICMJE
 (submitted: July 3, 2019)
  • Change in blood pressure during the nighttime sleep period [ Time Frame: Baseline, 6 week, 12 week, 6 month ]
    Average nighttime blood pressure (mmHg) measured by 24 hour ambulatory blood pressure monitoring before and after CBT-I
  • Change in sleep quality measured by actigraphy during the nighttime sleep period [ Time Frame: Baseline, 6 week, 12 week, 6 month ]
    Sleep efficiency (percent-time asleep during the sleep period) measured by actigraphy before and after CBT-I
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 6, 2020)
  • Change in awake blood pressure [ Time Frame: Baseline, 6 week, 12 week, 6 month ]
    Average awake blood pressure (mm Hg) measured by 24 hour ambulatory blood pressure monitoring before and after CBT-I
  • Change in nighttime blood pressure dipping [ Time Frame: Baseline, 6 week, 12 week, 6 month ]
    Average percent change in blood pressure (mm Hg) from awake to nighttime measured by 24 hour ambulatory blood pressure monitoring before and after CBT-I
  • Change in vascular endothelial function [ Time Frame: Baseline, 6 week, 12 week, 6 month ]
    Percent dilation of the brachial artery to reactive hyperemia measured by flow mediated dilation before and after CBT-I
  • Change in arterial stiffness [ Time Frame: 6 week, 6 month ]
    Pulse wave velocity (m/s) of the descending aorta measured using the Complior system before and after CBT-I
  • Change in lipid profile [ Time Frame: Baseline, 6 week, 12 week, 6 month ]
    Lipids (Total, HDL, LDL, Cholesterol and Triglycerides) from fasting venous blood draw measured before and after CBT-I
  • Change in nighttime sympathetic nervous system activity [ Time Frame: 6 week, 12 week ]
    Measured by 24 hour urine collection (awake and sleep period collection separated) assayed for catecholamines (epinephrine, norepinephrine) and creatinine before and after CBT-I
  • Change in cardiac structure [ Time Frame: 6 week, 6 month ]
    Cardiac left ventricular mass (g m^-2.7) before and after CBT-I
  • Change in cardiac function [ Time Frame: 6 week, 6 month ]
    Cardiac left ventricular strain (%) before and after CBT-I
  • Change in sleep fragmentation during the nighttime sleep period [ Time Frame: Baseline, 6 week, 12 week, 6 month ]
    Sleep Fragmentation Index measured by actigraphy before and after CBT-I.
  • Change in subjective sleep quality [ Time Frame: Baseline, 6 week, 12 week, 6 month ]
    Subjective Sleep Quality measured by Pittsburgh Sleep Quality Index before and after CBT-I.
  • Change in Office Blood Pressure [ Time Frame: Baseline, 6 week, 12 week, 6 month ]
    Average office seated blood pressure taken by automated clinic blood pressure monitor after 5 minutes rest and based on the average of 3 readings taken at one minute intervals (mm Hg)
Original Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2019)
  • Change in awake blood pressure [ Time Frame: Baseline, 6 week, 12 week, 6 month ]
    Average awake blood pressure (mmHg) measured by 24 hour ambulatory blood pressure monitoring before and after CBT-I
  • Change in nighttime blood pressure dipping [ Time Frame: Baseline, 6 week, 12 week, 6 month ]
    Average percent change in blood pressure (mmHg) from awake to nighttime measured by 24 hour ambulatory blood pressure monitoring before and after CBT-I
  • Change in vascular endothelial function [ Time Frame: Baseline, 6 week, 12 week, 6 month ]
    Percent dilation of the brachial artery to reactive hyperemia measured by flow mediated dilation before and after CBT-I
  • Change in arterial stiffness [ Time Frame: Baseline, 6 week, 12 week, 6 month ]
    Pulse wave velocity (m/s) of the descending aorta measured using the Complior system before and after CBT-I
  • Change in lipid profile [ Time Frame: Baseline, 6 week, 12 week, 6 month ]
    Lipids (Total, HDL, LDL, Cholesterol and Triglycerides) from fasting venous blood draw measured before and after CBT-I
  • Change in nighttime sympathetic nervous system activity [ Time Frame: Baseline, 6 week, 12 week, 6 month ]
    Measured by 24 hour urine collection (awake and sleep period collection separated) assayed for catecholamines (epinephrine, norepinephrine) before and after CBT-I
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sleep Quality and Mechanisms of Cardiovascular Risks in Adults With Hypertension
Official Title  ICMJE Sleep Quality and Mechanisms of Cardiovascular Risks in Adults With Hypertension
Brief Summary The objective of this study is to elucidate the potential mechanisms responsible for the increased risk of cardiovascular disease among patients with hypertension and comorbid insomnia.
Detailed Description The investigators propose to utilize a behavioral intervention to manipulate sleep quality in 150 adults with hypertension and comorbid insomnia, who will receive a 6-week Cognitive Behavioral therapy for Insomnia (CBT-I) intervention, which has been shown to markedly improve sleep quality and promote consolidated sleep in approximately 60% of those treated. A lowering of nighttime blood pressure is one of several proposed mechanisms to be examined.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
All participants will receive the Cognitive Behavioral Therapy for Insomnia
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Hypertension
  • Insomnia
Intervention  ICMJE Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)
6-week CBT-I therapy to help improve sleep quality
Study Arms  ICMJE Cognitive Behavioral Therapy for Insomnia
Cognitive Behavioral Therapy for Insomnia (CBT-I) 6 sessions of Cognitive Behavioral Training for Insomnia (1 hour each).
Intervention: Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 3, 2019) 		150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2024
Estimated Primary Completion Date June 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Systolic BP ≥ 130 mm Hg based upon two standardized BP screening assessments
  • A current diagnosis of insomnia disorder as defined in the International Classification of Sleep Disorders (ICSD-3); or undiagnosed, but suspected, insomnia disorder that is confirmed at their screening lab visit

Exclusion Criteria:

  • Uncontrolled hypertension (screening office BP > 160/100 mm Hg)
  • Antihypertensive medication use
  • Cardiovascular medications
  • Previously diagnosed moderate or severe obstructive sleep apnea
  • Severe obesity defined by BMI>40 kg/m2
  • Pacemakers
  • Atrial fibrillation
  • Acute coronary syndrome or coronary revascularization procedure within 6 months of enrollment
  • Congestive heart failure
  • Identifiable cause of hypertension (e.g., primary hyperaldosteronism, renal artery stenosis, untreated hyper- or hypothyroidism, chronic kidney disease, Cushing's disease, pheochromocytoma, coarctation of the aorta)
  • Severe uncorrected valvular heart disease
  • Current pregnancy
  • Active diagnosis of psychosis, bipolar disorder
  • Diabetes
  • Severely impaired hearing or speech
  • Participation in another interventional study to address insomnia
  • Rotating shift workers
  • Prominent suicidal or homicidal ideation (as assessed through a clinical interview)
  • Psychiatric Hospitalization within the past 12 months
  • Alcohol or drug abuse within 12 months
  • Exposure-based PTSD treatment
  • Dementia
  • Unstable comorbid sleep disorder requiring assessment and/or treatment outside of the study protocol
  • Medical or psychiatric conditions judged to be the primary cause of insomnia
  • Inability to comply with the assessment procedures or inability to provide informed consent.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kristy Johnson, MPH 919-681-5874 johns121@mc.duke.edu
Contact: Andrew Sherwood, PhD 919-684-8835 sherw002@mc.duke.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04009447
Other Study ID Numbers  ICMJE PRO00102036
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE National Institutes of Health (NIH)
Investigators  ICMJE
Principal Investigator: Andrew Sherwood, PhD Duke University
PRS Account Duke University
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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