Sleep Quality and Mechanisms of Cardiovascular Risks in Adults With Hypertension
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Duke University
- Enrollment
- 149
- Locations
- 1
- Primary Endpoint
- Change in Blood Pressure During the Nighttime Sleep Period
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
- •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.
Arms & Interventions
Cognitive Behavioral Therapy for Insomnia
Cognitive Behavioral Therapy for Insomnia (CBT-I) 6 sessions of Cognitive Behavioral Training for Insomnia (1 hour each).
Intervention: Cognitive Behavioral Therapy for Insomnia (CBT-I) (Behavioral)
Outcomes
Primary Outcomes
Change in Blood Pressure During the Nighttime Sleep Period
Time Frame: Baseline, 6 months post-intervention
Average nighttime blood pressure measured before CBT-I (Cognitive Behavioral Therapy for Insomnia) (baseline) and after CBT-I (6 months post-intervention).
Change in Sleep During the Nighttime Sleep Period as Measured by Sleep Diary
Time Frame: Baseline, 6 months post-intervention
Sleep efficiency (percent-time asleep during the sleep period) measured before CBT-I (Cognitive Behavioral Therapy for Insomnia) (baseline) and after CBT-I (6 months post-intervention).
Change in Sleep During the Nighttime Sleep Period as Measured by Actigraphy
Time Frame: Baseline, 6 months post-intervention
Sleep efficiency (percent-time asleep during the sleep period) measured by actigraphy before CBT-I (Cognitive Behavioral Therapy for Insomnia) (baseline) and after CBT-I (6 months post-intervention).
Changes in Insomnia Severity as Measured by the Insomnia Severity Index (ISI)
Time Frame: Baseline, 6 months post-intervention
The ISI is a seven-item questionnaire where respondents rate each element using Likert-type scales. Responses can range from 0 to 4 and are summed for a total score range of 0 to 28, where higher scores indicate more acute symptoms of insomnia.
Secondary Outcomes
- Change in Awake Blood Pressure(Baseline, 6 months post-intervention)
- Change in Nighttime Blood Pressure Dip Percentage(Baseline, 6 months post-intervention)
- Change in Vascular Endothelial Function(Baseline, 6 months post-intervention)
- Change in Arterial Stiffness(Baseline, 6 months post-intervention)
- Change in Lipid Profile - HDL (High-Density Lipoprotein), LDL (Low-Density Lipoprotein), and Triglycerides(Baseline, 6 months post-intervention)
- Change in Nighttime Sympathetic Nervous System Activity(Pre-CBT-I Baseline (6 weeks) to post-CBT-I (12 weeks))
- Change in Sleep Fragmentation During the Nighttime Sleep Period(Baseline, 6 weeks post-intervention)
- Change in Subjective Sleep Quality(Pre-CBT-I baseline (6 week) to post-CBT-I (12 weeks))
- Change in Clinic Blood Pressure(Baseline to 6 months post-intervention)