Sleep Quality and Mechanisms of Cardiovascular Risks in Adults With Hypertension

NCT04009447 | Completed Results

• 1 other identifier: PRO00102036
• Study Type: interventional
• Target: 149
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Insomnia

Outcome Measures

Primary Outcomes (4)

• Change in Blood Pressure During the Nighttime Sleep Period

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

  Baseline, 6 months post-intervention

• Change in Sleep During the Nighttime Sleep Period as Measured by Sleep Diary

  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).

  Baseline, 6 months post-intervention

• Change in Sleep During the Nighttime Sleep Period as Measured by Actigraphy

  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).

  Baseline, 6 months post-intervention

• Changes in Insomnia Severity as Measured by the Insomnia Severity Index (ISI)

  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.

  Baseline, 6 months post-intervention

Secondary Outcomes (9)

• Change in Awake Blood Pressure

  Baseline, 6 months post-intervention

• Change in Nighttime Blood Pressure Dip Percentage

  Baseline, 6 months post-intervention

• Change in Vascular Endothelial Function

  Baseline, 6 months post-intervention

• Change in Arterial Stiffness

  Baseline, 6 months post-intervention

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

  Baseline, 6 months post-intervention

Other Outcomes (2)

• Change in Cardiac Function

  6 week, 6 months post intervention

• Change in Cardiac Structure

  6 week, 6 months post intervention

Study Arms (1)

Cognitive Behavioral Therapy for Insomnia

OTHER

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

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

Interventions

Cognitive Behavioral Therapy for Insomnia (CBT-I) BEHAVIORAL

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

Cognitive Behavioral Therapy for Insomnia

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

• Sherwood A, Ulmer C, Wu JQ, Blumenthal JA, Herold E, Smith PJ, Koch GG, Johnson K, Viera A, Edinger J, Hinderliter A. Cognitive behavior therapy for insomnia for untreated hypertension with comorbid insomnia disorder: The SLEEPRIGHT clinical trial. J Clin Hypertens (Greenwich). 2024 Apr;26(4):441-447. doi: 10.1111/jch.14763. Epub 2024 Mar 11.

  PMID: 38468418 DERIVED

MeSH Terms

Conditions

Hypertension; Sleep Initiation and Maintenance Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Andrew Sherwood, Ph.D.
• Organization: Duke University

andrew.sherwood@duke.edu

919-684-8835

Study Officials

• Andrew Sherwood, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will receive the Cognitive Behavioral Therapy for Insomnia

Study Record Dates

• First Submitted: July 3, 2019
• First Posted: July 5, 2019
• Study Start: February 14, 2020
• Primary Completion: January 2, 2025
• Study Completion: January 2, 2025
• Last Updated: February 23, 2026
• Results First Posted: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)