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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6 week, 12 week, 6 months post intervention
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I have been diagnosed with insomnia or suspect I have it.

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

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

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
2,678 Previous Clinical Trials
6,909,646 Total Patients Enrolled
Duke UniversityLead Sponsor
2,351 Previous Clinical Trials
3,409,451 Total Patients Enrolled
Andrew Sherwood, PhDPrincipal InvestigatorDuke University
4 Previous Clinical Trials
696 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the central purposes of this investigation?

"The primary purpose of this trial, measured at Baseline, 6 week, 12 week and 6 month intervals, is to assess changes in nocturnal sleep. Secondary objectives are concerned with shifts in cardiac function (cardiac left ventricular strain %), cardiac structure (left ventricular mass gm-2.7) and arterial stiffness (pulse wave velocity m/s) before and after CBT-I implementation."

Answered by AI

What is the current number of participants involved in this research?

"Affirmative. According to the information available on clinicaltrials.gov, this medical research project is actively seeking out patients and was first posted on February 14th 2020. The study needs around 150 individuals at a single site to participate in its activities."

Answered by AI

Are there any opportunities to participate in this trial currently available?

"Affirmative. Clinicaltrials.gov displays that this clinical trial, which was first uploaded on February 14th 2020 is actively seeking volunteers. For the study to continue, 150 patients must be recruited from 1 test site."

Answered by AI

Is it permissible for someone aged 45 or older to join this research study?

"This clinical trial is accepting participants aged between 30 and 60 years old."

Answered by AI

Is there an opportunity to enroll in this experiment?

"To be eligible for this trial, the individual must suffer from hypertension and fall within an age range of 30 to 60 years. Approximately 150 people will be accepted into the study."

Answered by AI
~19 spots leftby Nov 2024