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Sleep Quality and Mechanisms of Cardiovascular Risks in Adults With Hypertension

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ClinicalTrials.gov Identifier: NCT04009447
Recruitment Status : Recruiting
First Posted : July 5, 2019
Last Update Posted : March 10, 2021
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Duke University

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.

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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

Resource links provided by the National Library of Medicine


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




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)



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04009447


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
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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
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Principal Investigator: Andrew Sherwood, PhD Duke University
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT04009447    
Other Study ID Numbers: PRO00102036
First Posted: July 5, 2019    Key Record Dates
Last Update Posted: March 10, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases