Sleep Quality and Mechanisms of Cardiovascular Risks in Adults With Hypertension

Duke University

Status: Completed

Conditions: Hypertension; Insomnia

Treatments: Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04009447

PRO00102036

Details and patient eligibility

About

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.

Full 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.

Enrollment: 149 patients

Sex: All

Ages: 30 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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149 participants in 1 patient group

Cognitive Behavioral Therapy for Insomnia

Other group

Description:

Cognitive Behavioral Therapy for Insomnia (CBT-I) 6 sessions of Cognitive Behavioral Training for Insomnia (1 hour each).

Treatment:

Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)