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Completed

NCT Number: NCT04009447

Sleep Quality and Mechanisms of Cardiovascular Risks in Adults With Hypertension

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Dyssomnias Insomnia Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Vascular Diseases

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cognitive Behavioral Therapy for Insomnia (CBT-I)

Behavioral

6-week CBT-I therapy to help improve sleep quality

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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

  1. Change in Awake Blood Pressure

    Time frame: Baseline, 6 months post-intervention

    Average awake blood pressure (mm Hg) measured by 24 hour ambulatory blood pressure monitoring before CBT-I (Cognitive Behavioral Therapy for Insomnia) (baseline) and after CBT-I (6 months post-intervention).

  2. Change in Nighttime Blood Pressure Dip Percentage

    Time frame: Baseline, 6 months post-intervention

    Average percent change in blood pressure before CBT-I (Cognitive Behavioral Therapy for Insomnia) (baseline) and after CBT-I (6 months post-intervention).

  3. Change in Vascular Endothelial Function

    Time frame: Baseline, 6 months post-intervention

    Percent dilation of the brachial artery to reactive hyperemia measured by flow mediated dilation before CBT-I (Cognitive Behavioral Therapy for Insomnia) (baseline) and after CBT-I (6 months post-intervention).

  4. Change in Arterial Stiffness

    Time frame: Baseline, 6 months post-intervention

    Pulse wave velocity (m/s) of the descending aorta measured using the Complior system before CBT-I (Cognitive Behavioral Therapy for Insomnia) (baseline) and after CBT-I (6 months post-intervention).

  5. Change in Lipid Profile - HDL (High-Density Lipoprotein), LDL (Low-Density Lipoprotein), and Triglycerides

    Time frame: Baseline, 6 months post-intervention

    Lipids (HDL, LDL, and Triglycerides) from fasting venous blood draw measured before CBT-I (Cognitive Behavioral Therapy for Insomnia) (baseline) and after CBT-I (6 months post-intervention).

  6. Change in Nighttime Sympathetic Nervous System Activity

    Time frame: Pre-CBT-I Baseline (6 weeks) to post-CBT-I (12 weeks)

    Measured by 24 hour urine collection (awake and sleep period collection separated) assayed for catecholamines (epinephrine, norepinephrine) before and after CBT-I. Adjusted via creatinine normalization by dividing by the urine creatinine concentration.

  7. Change in Sleep Fragmentation During the Nighttime Sleep Period

    Time frame: Baseline, 6 weeks post-intervention

    Sleep Fragmentation Index (SFI) measured by actigraphy before CBT-I (Cognitive Behavioral Therapy for Insomnia) (baseline) and after CBT-I (6 weeks post-intervention). The SFI measures how often sleep is interrupted by brief awakenings or shifts between sleep stages, calculated by dividing the number of these transitions by total sleep time

  8. Change in Subjective Sleep Quality

    Time frame: Pre-CBT-I baseline (6 week) to post-CBT-I (12 weeks)

    Subjective Sleep Quality measured by Pittsburgh Sleep Quality Index (PSQI) before and after CBT-I. The PSQI is a widely used, self-report questionnaire that assesses sleep quality and disturbances over a one-month period, identifying factors like sleep latency (time to fall asleep), duration, disturbances, medication use, and daytime dysfunction, yielding a global score (0-21) where higher scores indicate poorer sleep.

  9. Change in Clinic Blood Pressure

    Time frame: Baseline to 6 months post-intervention

    Average office seated blood pressure taken by automated clinic blood pressure monitor after 5 minutes rest and based on the average of 3 readings taken at one minute intervals (mm Hg)

Other outcomes

  1. Change in Cardiac Function

    Time frame: 6 week, 6 months post intervention

    Cardiac left ventricular strain (%) before and after CBT-I

  2. Change in Cardiac Structure

    Time frame: 6 week, 6 months post intervention

    Cardiac left ventricular mass (g m^-2.7) before and after CBT-I

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Jul 5, 2019
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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