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Behavioral Intervention

Cognitive Behavioral Therapy for Insomnia in High Blood Pressure

N/A
Waitlist Available
Led By Andrew Sherwood, PhD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Be between 18 and 65 years old
Must not have
Congestive heart failure
Diabetes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6 week, 12 week, 6 months post intervention
Awards & highlights
No Placebo-Only Group

Summary

This trial looks at the connection between high blood pressure, insomnia, and heart disease.

Who is the study for?
This trial is for adults with high blood pressure (systolic BP ≥ 130 mm Hg) and insomnia, either diagnosed or suspected. It's not for those who've had recent heart issues, severe heart conditions, are pregnant, have severe obesity (BMI>40), uncontrolled hypertension (>160/100 mm Hg), certain mental health disorders, substance abuse history within the last year, or other specific medical exclusions.
What is being tested?
The study tests if Cognitive Behavioral Therapy for Insomnia (CBT-I) can reduce cardiovascular risks in patients with both hypertension and insomnia. The goal is to understand how treating insomnia affects heart health in these individuals.
What are the potential side effects?
CBT-I generally has minimal side effects compared to medication; however, some may experience temporary increases in anxiety or stress during therapy as they change their sleep habits and confront beliefs about sleep.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with insomnia or suspect I have it.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with congestive heart failure.
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I have diabetes.
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I have severe hearing or speech impairments.
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I have been diagnosed with moderate or severe sleep apnea.
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I have atrial fibrillation.
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I have a sleep disorder that needs treatment beyond this study.
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I have been diagnosed with psychosis or bipolar disorder.
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I have a known cause for my high blood pressure.
Select...
I have serious heart valve problems that haven't been treated.
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My BMI is over 40.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6 week, 12 week, 6 months post intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 week, 12 week, 6 months post intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in blood pressure during the nighttime sleep period
Change in sleep during the nighttime sleep period
Changes in insomnia severity
Secondary study objectives
Change in Office Blood Pressure
Change in arterial stiffness
Change in awake blood pressure
+8 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Cognitive Behavioral Therapy for InsomniaExperimental Treatment1 Intervention
Cognitive Behavioral Therapy for Insomnia (CBT-I) 6 sessions of Cognitive Behavioral Training for Insomnia (1 hour each).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive Behavioral Therapy for Insomnia (CBT-I)
2014
N/A
~720

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH
2,818 Previous Clinical Trials
8,161,545 Total Patients Enrolled
Duke UniversityLead Sponsor
2,455 Previous Clinical Trials
2,970,929 Total Patients Enrolled
Andrew Sherwood, PhDPrincipal InvestigatorDuke University
4 Previous Clinical Trials
666 Total Patients Enrolled

Media Library

Cognitive Behavioral Therapy for Insomnia (CBT-I) (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04009447 — N/A
High Blood Pressure Research Study Groups: Cognitive Behavioral Therapy for Insomnia
High Blood Pressure Clinical Trial 2023: Cognitive Behavioral Therapy for Insomnia (CBT-I) Highlights & Side Effects. Trial Name: NCT04009447 — N/A
Cognitive Behavioral Therapy for Insomnia (CBT-I) (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04009447 — N/A
~26 spots leftby Dec 2025
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