Hypertension, Insomnia Clinical Trial
Official title:
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.
| Status | Not yet recruiting |
| Enrollment | 150 |
| Est. completion date | June 2024 |
| Est. primary completion date | June 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 30 Years to 60 Years |
| Eligibility |
Inclusion Criteria: - Systolic blood pressure = 130 mm Hg based upon two standardized clinic blood pressure screening assessments - A current diagnosis of insomnia disorder as defined in the International Classification of Sleep Disorders (ICSD-3);84 or undiagnosed, but suspected, or insomnia disorder that is confirmed at a screening lab visit Exclusion Criteria: - Uncontrolled hypertension (screening office blood pressure > 160/100 mm Hg) - Antihypertensive medication use - Cardiovascular medications - Previously diagnosed 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 - Current use of benzodiazepine or benzodiazepine receptor agonists, opiates, or trazodone; termination of benzodiazepine or benzodiazepine receptor agonists, anticonvulsants, atypical antipsychotic medication, or antidepressant medications in the past two weeks or plans to take these medications during the course of study participation (those on stable use of antidepressant medications will be included) - Active diagnosis of psychosis, bipolar disorder - 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) - Alcohol or drug abuse within 12 months - Hepatic dysfunction - Dementia - Inability to comply with the assessment procedures or inability to provide informed consent. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Duke University Medical Center | Durham | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Duke University | National Institutes of Health (NIH) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in blood pressure during the nighttime sleep period | Average nighttime blood pressure (mmHg) measured by 24 hour ambulatory blood pressure monitoring before and after CBT-I | Baseline, 6 week, 12 week, 6 month | |
| Primary | Change in sleep quality measured by actigraphy during the nighttime sleep period | Sleep efficiency (percent-time asleep during the sleep period) measured by actigraphy before and after CBT-I | Baseline, 6 week, 12 week, 6 month | |
| Secondary | Change in awake blood pressure | Average awake blood pressure (mmHg) measured by 24 hour ambulatory blood pressure monitoring before and after CBT-I | Baseline, 6 week, 12 week, 6 month | |
| Secondary | 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 | |
| Secondary | Change in arterial stiffness | Pulse wave velocity (m/s) of the descending aorta measured using the Complior system before and after CBT-I | Baseline, 6 week, 12 week, 6 month | |
| Secondary | 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 | |
| Secondary | Change in nighttime sympathetic nervous system activity | Measured by 24 hour urine collection (awake and sleep period collection separated) assayed for catecholamine (epinephrine, norepinephrine) before and after CBT-I | Baseline, 6 week, 12 week, 6 month |