Sleep Quality and Mechanisms of Cardiovascular Risks in Adults With Hypertension

Study Overview
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Brief Summary
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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
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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.

Official Title
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Sleep Quality and Mechanisms of Cardiovascular Risks in Adults With Hypertension

Conditions
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Hypertension, Insomnia

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: All participants will receive the Cognitive Behavioral Therapy for Insomnia
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cognitive Behavioral Therapy for Insomnia<br>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)<br>* 6-week CBT-I therapy to help improve sleep quality<br>|

What is the study measuring?
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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 month | 
| 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 month | 
| Changes in insomnia severity | Insomnia measured by the Insomnia Severity Index before and after CBT-I. | Baseline, 6 week, 12 week, 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 month | 
| 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 month | 
| 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 month | 
| 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 month | 
| 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 month | 
| 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 cardiac structure | Cardiac left ventricular mass (g m^-2.7) before and after CBT-I | 6 week, 6 month | 
| Change in cardiac function | Cardiac left ventricular strain (%) before and after CBT-I | 6 week, 6 month | 
| 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 month | 
| 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 month | 
| 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 month |