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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

Sleep Quality and Mechanisms of Cardiovascular Risks in Adult With Hypertension

Clinicaltrials.gov identifier NCT03946605

Recruitment Status Not yet recruiting

First Posted May 10, 2019

Last update posted May 10, 2019

Study Description

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.

  • Condition or Disease:Hypertension, Insomnia
  • Intervention/Treatment: Behavioral: Cognitive Behavioral Therapy for Insomnia
  • Phase: N/A
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 Behaviorial 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.

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 150 participants
  • Intervention Model: Single Group Assignment
  • Intervention Model Description: All participants will receive the Cognitive Behaviorial Therapy for Insomnia.
  • Masking: None (Open Label) ()
  • Primary Purpose: Other
  • Official Title: Sleep Quality and Mechanisms of Cardiovascular Risks in Adults With Hypertension
  • Estimated Study Start Date: July 2019
  • Estimated Primary Completion Date: June 2024
  • Estimated Study Completion Date: June 2024
Arms and interventions
Arm Intervention/treatment
Other: Cognitive Behavioral Training for Insomnia (CBT-I)
6 sessions of Cognitive Behavioral Training for Insomnia (1 hour each).
Behavioral: Cognitive Behavioral Therapy for Insomnia
6-week CBT-I therapy to help improve sleep quality.
Outcome Measures
  • Primary Outcome Measures: 1. Change in blood pressure during the nighttime sleep period [ Time Frame: Baseline, 6 week, 12 week, 6 month ]
    Average nighttime blood pressure (mmHg) measured by 24 hour ambulatory blood pressure monitoring before and after CBT-I
  • 2. Change in sleep quality measured by actigraphy during the nighttime sleep period [ Time Frame: Baseline, 6 week, 12 week, 6 month ]
    Sleep efficiency (percent-time asleep during the sleep period) measured by actigraphy before and after CBT-I
  • Secondary Outcome Measures: 1. Change in awake blood pressure [ Time Frame: Baseline, 6 week, 12 week, 6 month ]
    Average awake blood pressure (mmHg) measured by 24 hour ambulatory blood pressure monitoring before and after CBT-I
  • 2. Change in vascular endothelial function [ Time Frame: Baseline, 6 week, 12 week, 6 month ]
    Percent dilation of the brachial artery to reactive hyperemia measured by flow mediated dilation before and after CBT-I
  • 3. Change in arterial stiffness [ Time Frame: Baseline, 6 week, 12 week, 6 month ]
    Pulse wave velocity (m/s) of the descending aorta measured using the Complior system before and after CBT-I
  • 4. Change in lipid profile [ Time Frame: Baseline, 6 week, 12 week, 6 month ]
    Lipids (Total, HDL, LDL, Cholesterol and Triglycerides) from fasting venous blood draw measured before and after CBT-I
  • 5. Change in nighttime sympathetic nervous system activity [ Time Frame: Baseline, 6 week, 12 week, 6 month ]
    Measured by 24 hour urine collection (awake and sleep period collection separated) assayed for catecholamine (epinephrine, norepinephrine) before and after CBT-I
Eligibility Criteria
  • Ages Eligible for Study: 30 to 60 Years (Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

- Systolic blood pressure ≥ 130 mm Hg based upon two standardized clinic blood pressure
screening assessments

- A current diagnosis of insomnia disorder as defined in the International
Classification of Sleep Disorders (ICSD-3);84 or undiagnosed, but suspected, or
insomnia disorder that is confirmed at a screening lab visit

Exclusion Criteria:

- Uncontrolled hypertension (screening office blood pressure > 160/100 mm Hg)

- Antihypertensive medication use

- Cardiovascular medications

- Previously diagnosed 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

- Current use of benzodiazepine or benzodiazepine receptor agonists, opiates, or
trazodone; termination of benzodiazepine or benzodiazepine receptor agonists,
anticonvulsants, atypical antipsychotic medication, or antidepressant medications in
the past two weeks or plans to take these medications during the course of study
participation (those on stable use of antidepressant medications will be included)

- 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)

- Alcohol or drug abuse within 12 months

- Hepatic dysfunction

- Dementia

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

Contacts and Locations
Contacts

Contact: Andrew Sherwood, PhD 919-684-8835 sherw002@mc.duke.edu

Contact: Kristy Johnson, MPH 919-681-5874 johns121@mc.duke.edu

Locations

United States, North Carolina
Duke University Medical Center
Durham

Sponsors and Collaborators

Duke University

National Institutes of Health (NIH)

More Information
  • Responsible Party: Duke University
  • ClinicalTrials.gov Identifier: NCT03946605 History of Changes
  • Other Study ID Numbers: PRO00102036
  • First Posted: May 10, 2019 Key Record Dates
  • Last Update Posted: May 10, 2019
  • Last Verified: April 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Hypertension