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Sleep Quality and Mechanisms of Cardiovascular Risks in Adults With Hypertension

Primary Purpose

Hypertension, Insomnia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy for Insomnia (CBT-I)
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hypertension

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Duke University Medical CenterRecruiting
  • Duke University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Cognitive Behavioral Therapy for Insomnia

Arm Description

Cognitive Behavioral Therapy for Insomnia (CBT-I) 6 sessions of Cognitive Behavioral Training for Insomnia (1 hour each).

Outcomes

Primary Outcome Measures

Change in blood pressure during the nighttime sleep period
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
Sleep efficiency (percent-time asleep during the sleep period) measured by sleep diary and actigraphy before and after CBT-I.
Changes in insomnia severity
Insomnia measured by the Insomnia Severity Index before and after CBT-I.

Secondary Outcome Measures

Change in awake blood pressure
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
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
Percent dilation of the brachial artery to reactive hyperemia measured by flow mediated dilation before and after CBT-I
Change in arterial stiffness
Pulse wave velocity (m/s) of the descending aorta measured using the Complior system before and after CBT-I
Change in lipid profile
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
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
Cardiac left ventricular mass (g m^-2.7) before and after CBT-I
Change in cardiac function
Cardiac left ventricular strain (%) before and after CBT-I
Change in sleep fragmentation during the nighttime sleep period
Sleep Fragmentation Index measured by actigraphy before and after CBT-I.
Change in subjective sleep quality
Subjective Sleep Quality measured by Pittsburgh Sleep Quality Index before and after CBT-I.
Change in Office Blood Pressure
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)

Full Information

First Posted
July 3, 2019
Last Updated
April 17, 2023
Sponsor
Duke University
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT04009447
Brief Title
Sleep Quality and Mechanisms of Cardiovascular Risks in Adults With Hypertension
Official Title
Sleep Quality and Mechanisms of Cardiovascular Risks in Adults With Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 14, 2020 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
National Institutes of Health (NIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Insomnia

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All participants will receive the Cognitive Behavioral Therapy for Insomnia
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Behavioral Therapy for Insomnia
Arm Type
Other
Arm Description
Cognitive Behavioral Therapy for Insomnia (CBT-I) 6 sessions of Cognitive Behavioral Training for Insomnia (1 hour each).
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy for Insomnia (CBT-I)
Intervention Description
6-week CBT-I therapy to help improve sleep quality
Primary Outcome Measure Information:
Title
Change in blood pressure during the nighttime sleep period
Description
Average nighttime blood pressure (mm Hg) measured by 24 hour ambulatory blood pressure monitoring before and after CBT-I
Time Frame
Baseline, 6 week, 12 week, 6 month
Title
Change in sleep during the nighttime sleep period
Description
Sleep efficiency (percent-time asleep during the sleep period) measured by sleep diary and actigraphy before and after CBT-I.
Time Frame
Baseline, 6 week, 12 week, 6 month
Title
Changes in insomnia severity
Description
Insomnia measured by the Insomnia Severity Index before and after CBT-I.
Time Frame
Baseline, 6 week, 12 week, 6 month
Secondary Outcome Measure Information:
Title
Change in awake blood pressure
Description
Average awake blood pressure (mm Hg) measured by 24 hour ambulatory blood pressure monitoring before and after CBT-I
Time Frame
Baseline, 6 week, 12 week, 6 month
Title
Change in nighttime blood pressure dipping
Description
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
Time Frame
Baseline, 6 week, 12 week, 6 month
Title
Change in vascular endothelial function
Description
Percent dilation of the brachial artery to reactive hyperemia measured by flow mediated dilation before and after CBT-I
Time Frame
Baseline, 6 week, 12 week, 6 month
Title
Change in arterial stiffness
Description
Pulse wave velocity (m/s) of the descending aorta measured using the Complior system before and after CBT-I
Time Frame
6 week, 6 month
Title
Change in lipid profile
Description
Lipids (Total, HDL, LDL, Cholesterol and Triglycerides) from fasting venous blood draw measured before and after CBT-I
Time Frame
Baseline, 6 week, 12 week, 6 month
Title
Change in nighttime sympathetic nervous system activity
Description
Measured by 24 hour urine collection (awake and sleep period collection separated) assayed for catecholamines (epinephrine, norepinephrine) and creatinine before and after CBT-I
Time Frame
6 week, 12 week
Title
Change in cardiac structure
Description
Cardiac left ventricular mass (g m^-2.7) before and after CBT-I
Time Frame
6 week, 6 month
Title
Change in cardiac function
Description
Cardiac left ventricular strain (%) before and after CBT-I
Time Frame
6 week, 6 month
Title
Change in sleep fragmentation during the nighttime sleep period
Description
Sleep Fragmentation Index measured by actigraphy before and after CBT-I.
Time Frame
Baseline, 6 week, 12 week, 6 month
Title
Change in subjective sleep quality
Description
Subjective Sleep Quality measured by Pittsburgh Sleep Quality Index before and after CBT-I.
Time Frame
Baseline, 6 week, 12 week, 6 month
Title
Change in Office Blood Pressure
Description
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)
Time Frame
Baseline, 6 week, 12 week, 6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kristy Johnson, MPH
Phone
919-681-5874
Email
johns121@mc.duke.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Andrew Sherwood, PhD
Phone
919-684-8835
Email
sherw002@mc.duke.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Sherwood, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Sherwood, PhD
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristy S Johnson, MPH
Phone
919-681-5874
Email
johns121@mc.duke.edu
First Name & Middle Initial & Last Name & Degree
Andrew Sherwood, PhD
Phone
919-684-8835
Email
sherw002@mc.duke.edu
First Name & Middle Initial & Last Name & Degree
Andrew Sherwood, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Sleep Quality and Mechanisms of Cardiovascular Risks in Adults With Hypertension

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