Status:
COMPLETED
Sleep Quality and Mechanisms of Cardiovascular Risks in Adults With Hypertension
Lead Sponsor:
Duke University
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Hypertension
Insomnia
Eligibility:
All Genders
30-60 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 2 2025
Estimated Enrollment :
149 Patients enrolled
Trial Details
Trial ID
NCT04009447
Start Date
February 14 2020
End Date
January 2 2025
Last Update
January 7 2025
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710