Clinical trial NCT04009447: Sleep Quality and Mechanisms of Cardiovascular Risks in Adults With Hypertension
Official title: Sleep Quality and Mechanisms of Cardiovascular Risks in Adults With Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Insomnia
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2019-07-05
Enrollment: 149
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants will receive the Cognitive Behavioral Therapy for Insomnia
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in blood pressure during the nighttime sleep period
timeFrame: Baseline, 6 week, 12 week, 6 months post intervention
measure: Change in sleep during the nighttime sleep period
timeFrame: Baseline, 6 week, 12 week, 6 months post intervention
measure: Changes in insomnia severity
timeFrame: Baseline, 6 week, 12 week, 6 months post intervention
Secondary outcomes:
measure: Change in awake blood pressure
timeFrame: Baseline, 6 week, 12 week, 6 months post intervention
measure: Change in nighttime blood pressure dipping
timeFrame: Baseline, 6 week, 12 week, 6 months post intervention
measure: Change in vascular endothelial function
timeFrame: Baseline, 6 week, 12 week, 6 months post intervention
measure: Change in arterial stiffness
timeFrame: 6 week, 6 months post intervention
measure: Change in lipid profile
timeFrame: Baseline, 6 week, 12 week, 6 months post intervention
measure: Change in nighttime sympathetic nervous system activity
timeFrame: 6 week, 12 week
measure: Change in cardiac structure
timeFrame: 6 week, 6 months post intervention
measure: Change in cardiac function
timeFrame: 6 week, 6 months post intervention
measure: Change in sleep fragmentation during the nighttime sleep period
timeFrame: Baseline, 6 week, 12 week, 6 months post intervention
measure: Change in subjective sleep quality
timeFrame: Baseline, 6 week, 12 week, 6 months post intervention
measure: Change in Office Blood Pressure
timeFrame: Baseline, 6 week, 12 week, 6 months post intervention
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Andrew Sherwood, PhD
role: PRINCIPAL_INVESTIGATOR
References: