Sleep Quality and Mechanisms of Cardiovascular Risks in Adults With Hypertension

  • End date
    Jun 11, 2024
  • participants needed
  • sponsor
    Duke University
Updated on 11 May 2022
cardiovascular disease
behavior therapy
cognitive therapy
sleep disorder
cognitive behavioral therapy for insomnia


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.


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.

Condition Hypertension, Insomnia
Treatment Cognitive Behavioral Therapy for Insomnia (CBT-I)
Clinical Study IdentifierNCT04009447
SponsorDuke University
Last Modified on11 May 2022


Yes No Not Sure

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
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
Inability to comply with the assessment procedures or inability to provide informed consent
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
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