Sleep Quality and Mechanisms of Cardiovascular Risks in Adults With Hypertension

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hypertension; Insomnia
• Intervention / Treatment: Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)

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: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kristy Johnson, MPH; Phone Number: 919-681-5874; Email: johns121@mc.duke.edu
• Study Contact Backup: Name: Andrew Sherwood, PhD; Phone Number: 919-684-8835; Email: sherw002@mc.duke.edu

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline, 6 week, 12 week, 6 months post intervention
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.	Baseline, 6 week, 12 week, 6 months post intervention
Changes in insomnia severity	Insomnia measured by the Insomnia Severity Index before and after CBT-I.	Baseline, 6 week, 12 week, 6 months post intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 week, 12 week
Change in awake blood pressure	Average awake blood pressure (mm Hg) measured by 24 hour ambulatory blood pressure monitoring before and after CBT-I	Baseline, 6 week, 12 week, 6 months post intervention
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	Baseline, 6 week, 12 week, 6 months post intervention
Change in vascular endothelial function	Percent dilation of the brachial artery to reactive hyperemia measured by flow mediated dilation before and after CBT-I	Baseline, 6 week, 12 week, 6 months post intervention
Change in arterial stiffness	Pulse wave velocity (m/s) of the descending aorta measured using the Complior system before and after CBT-I	6 week, 6 months post intervention
Change in lipid profile	Lipids (Total, HDL, LDL, Cholesterol and Triglycerides) from fasting venous blood draw measured before and after CBT-I	Baseline, 6 week, 12 week, 6 months post intervention
Change in cardiac structure	Cardiac left ventricular mass (g m^-2.7) before and after CBT-I	6 week, 6 months post intervention
Change in cardiac function	Cardiac left ventricular strain (%) before and after CBT-I	6 week, 6 months post intervention
Change in sleep fragmentation during the nighttime sleep period	Sleep Fragmentation Index measured by actigraphy before and after CBT-I.	Baseline, 6 week, 12 week, 6 months post intervention
Change in subjective sleep quality	Subjective Sleep Quality measured by Pittsburgh Sleep Quality Index before and after CBT-I.	Baseline, 6 week, 12 week, 6 months post intervention
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)	Baseline, 6 week, 12 week, 6 months post intervention

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Andrew Sherwood, PhD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2020
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: July 3, 2019
• First Submitted That Met QC Criteria: July 3, 2019
• First Posted (Actual): July 5, 2019

Study Record Updates

• Last Update Posted (Estimated): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: PRO00102036

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No