Sleep Quality and Mechanisms of Cardiovascular Risks in Adults With Hypertension
- Conditions
- HypertensionInsomnia
- Interventions
- Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)
- Registration Number
- NCT04009447
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 149
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cognitive Behavioral Therapy for Insomnia Cognitive Behavioral Therapy for Insomnia (CBT-I) Cognitive Behavioral Therapy for Insomnia (CBT-I) 6 sessions of Cognitive Behavioral Training for Insomnia (1 hour each).
- Primary Outcome Measures
Name Time Method Changes in insomnia severity Baseline, 6 week, 12 week, 6 months post intervention Insomnia measured by the Insomnia Severity Index before and after CBT-I.
Change in blood pressure during the nighttime sleep period Baseline, 6 week, 12 week, 6 months post intervention 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 Baseline, 6 week, 12 week, 6 months post intervention Sleep efficiency (percent-time asleep during the sleep period) measured by sleep diary and actigraphy before and after CBT-I.
- Secondary Outcome Measures
Name Time Method Change in cardiac structure 6 week, 6 months post intervention Cardiac left ventricular mass (g m\^-2.7) before and after CBT-I
Change in cardiac function 6 week, 6 months post intervention Cardiac left ventricular strain (%) before and after CBT-I
Change in nighttime blood pressure dipping Baseline, 6 week, 12 week, 6 months post intervention 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 nighttime sympathetic nervous system activity 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 arterial stiffness 6 week, 6 months post intervention Pulse wave velocity (m/s) of the descending aorta measured using the Complior system before and after CBT-I
Change in awake blood pressure Baseline, 6 week, 12 week, 6 months post intervention Average awake blood pressure (mm Hg) measured by 24 hour ambulatory blood pressure monitoring before and after CBT-I
Change in lipid profile Baseline, 6 week, 12 week, 6 months post intervention Lipids (Total, HDL, LDL, Cholesterol and Triglycerides) from fasting venous blood draw measured before and after CBT-I
Change in vascular endothelial function Baseline, 6 week, 12 week, 6 months post intervention Percent dilation of the brachial artery to reactive hyperemia measured by flow mediated dilation before and after CBT-I
Change in sleep fragmentation during the nighttime sleep period Baseline, 6 week, 12 week, 6 months post intervention Sleep Fragmentation Index measured by actigraphy before and after CBT-I.
Change in subjective sleep quality Baseline, 6 week, 12 week, 6 months post intervention Subjective Sleep Quality measured by Pittsburgh Sleep Quality Index before and after CBT-I.
Change in Office Blood Pressure Baseline, 6 week, 12 week, 6 months post intervention 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)
Trial Locations
- Locations (1)
Duke University Medical Center
🇺🇸Durham, North Carolina, United States