HypertensionNCT04009447

Sleep Quality and Mechanisms of Cardiovascular Risks in Adults With Hypertension

A study testing Cognitive Behavioral Therapy for Insomnia (CBT-I) in people with Hypertension and Insomnia, run by Duke University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 30 to 60 years
Conditions the study is for: Hypertension, Insomnia
What is being tested?: Cognitive Behavioral Therapy for Insomnia (CBT-I)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 149 participants
Where: 1 siteUnited States
Study dates: 14 Feb 2020to 2 Jan 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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

Show all 25Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Duke University Medical Center
Durham, North Carolina, 27710

Other trials in United States

About this study

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.

Read the 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 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.

Conditions: Hypertension, Insomnia
Being tested: Cognitive Behavioral Therapy for Insomnia (CBT-I)
Medical subject headings: Hypertension, Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cognitive Behavioral Therapy for Insomnia (CBT-I)Behavioural
6-week CBT-I therapy to help improve sleep quality

Study groups in NCT04009447
Study group	Role	What they receive
Cognitive Behavioral Therapy for Insomnia	Other	Cognitive Behavioral Therapy for Insomnia (CBT-I) 6 sessions of Cognitive Behavioral Training for Insomnia (1 hour each). Receives: Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: Baseline, 6 months post-intervention

Secondary outcomes (9)

Change in Awake Blood Pressure
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).
Measured: Baseline, 6 months post-intervention
Change in Nighttime Blood Pressure Dip Percentage
Average percent change in blood pressure before CBT-I (Cognitive Behavioral Therapy for Insomnia) (baseline) and after CBT-I (6 months post-intervention).
Measured: Baseline, 6 months post-intervention
Change in Vascular Endothelial Function
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).
Measured: Baseline, 6 months post-intervention
Change in Arterial Stiffness
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).
Measured: Baseline, 6 months post-intervention
Change in Lipid Profile - HDL (High-Density Lipoprotein), LDL (Low-Density Lipoprotein), and Triglycerides
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).
Measured: Baseline, 6 months post-intervention
Change in Nighttime Sympathetic Nervous System Activity
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.
Measured: Pre-CBT-I Baseline (6 weeks) to post-CBT-I (12 weeks)
Change in Sleep Fragmentation During the Nighttime Sleep Period
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
Measured: Baseline, 6 weeks post-intervention
Change in Subjective Sleep Quality
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.
Measured: Pre-CBT-I baseline (6 week) to post-CBT-I (12 weeks)
Change in Clinic Blood Pressure
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)
Measured: Baseline to 6 months post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Feb 20202 Jan 2025

First posted5 Jul 2019
Study start14 Feb 2020
Primary completion2 Jan 2025
Study completion2 Jan 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HypertensionStudies of the same condition, open and under way.
More trials run by Duke UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Model description: All participants will receive the Cognitive Behavioral Therapy for Insomnia
Masking: None (open label)
Enrolment: 149 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04009447
Sponsor's protocol ID: PRO00102036
Status last verified: Feb 2026
First submitted: 3 Jul 2019
Last updated: 23 Feb 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 38468418

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Sleep Quality and Mechanisms of Cardiovascular Risks in Adults With Hypertension
ClinicalTrials.gov ID: NCT04009447
Acronym / sponsor ID: PRO00102036
Conditions: Hypertension, Insomnia
Study type: Interventional
Recruitment status: Completed
Enrolment: 149 participants (actual)
Lead sponsor: Duke UniversityUniversity, hospital or other
Collaborators: National Institutes of Health (NIH)
Study start: 14 Feb 2020 (actual)
Primary completion: 2 Jan 2025 (actual)
Study completion: 2 Jan 2025 (actual)
First posted: 5 Jul 2019 (actual)
Results: Posted 23 Feb 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: All participants will receive the Cognitive Behavioral Therapy for Insomnia

Arm	Type	Receives
Cognitive Behavioral Therapy for Insomnia	Other	Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)Cognitive Behavioral Therapy for Insomnia (CBT-I) 6 sessions of Cognitive Behavioral Training for Insomnia (1 hour each).

Who may qualify

Ages: 30 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (25 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Cognitive Behavioral Therapy for Insomnia (CBT-I)6-week CBT-I therapy to help improve sleep quality	Behavioural	Cognitive Behavioral Therapy for Insomnia

Primary outcome

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).
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).
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).
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.

9 secondary outcomes

Change in Awake Blood Pressure
Time frame: Baseline, 6 months post-intervention
Change in Nighttime Blood Pressure Dip Percentage
Time frame: Baseline, 6 months post-intervention
Change in Vascular Endothelial Function
Time frame: Baseline, 6 months post-intervention
Change in Arterial Stiffness
Time frame: Baseline, 6 months post-intervention
Change in Lipid Profile - HDL (High-Density Lipoprotein), LDL (Low-Density Lipoprotein), and Triglycerides
Time frame: Baseline, 6 months post-intervention
Change in Nighttime Sympathetic Nervous System Activity
Time frame: Pre-CBT-I Baseline (6 weeks) to post-CBT-I (12 weeks)
Change in Sleep Fragmentation During the Nighttime Sleep Period
Time frame: Baseline, 6 weeks post-intervention
Change in Subjective Sleep Quality
Time frame: Pre-CBT-I baseline (6 week) to post-CBT-I (12 weeks)
Change in Clinic Blood Pressure
Time frame: Baseline to 6 months post-intervention

Results and safety

Results posted to the registry on 23 Feb 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cognitive Behavioral Therapy for Insomnia	149	127

Primary outcome: Change in Blood Pressure During the Nighttime Sleep Period

Time frame: Baseline, 6 months post-intervention. Mean (95% Confidence Interval). Unit: mmHg

Measure	Cognitive Behavioral Therapy for Insomnia n = 127
Systolic blood pressure (SBP)	-2.48 (-4.20 to -0.70)
Diastolic blood pressure (DBP)	-1.90 (-3.10 to -0.70)

Cognitive Behavioral Therapy for Insomnia: p = 0.002, Mixed Models Analysis
Cognitive Behavioral Therapy for Insomnia: p = 0.001, Mixed Models Analysis

Population analysed: Participants who completed the study.

Primary outcome: Change in Sleep During the Nighttime Sleep Period as Measured by Sleep Diary

Time frame: Baseline, 6 months post-intervention. Mean (95% Confidence Interval). Unit: percentage of time asleep

Measure	Cognitive Behavioral Therapy for Insomnia n = 127
Value	6.9 (6.2 to 7.6)

Cognitive Behavioral Therapy for Insomnia: p <0.001, Mixed Models Analysis

Population analysed: Participants who completed the study.

Primary outcome: Change in Sleep During the Nighttime Sleep Period as Measured by Actigraphy

Time frame: Baseline, 6 months post-intervention. Mean (95% Confidence Interval). Unit: percentage of time asleep

Measure	Cognitive Behavioral Therapy for Insomnia n = 127
Value	1.4 (-0.6 to 3.5)

Cognitive Behavioral Therapy for Insomnia: p = 0.173, Mixed Models Analysis

Population analysed: Participants who completed the study.

Primary outcome: Changes in Insomnia Severity as Measured by the Insomnia Severity Index (ISI)

Time frame: Baseline, 6 months post-intervention. Mean (95% Confidence Interval). Unit: score on a scale

Measure	Cognitive Behavioral Therapy for Insomnia n = 127
Value	-7.9 (-8.8 to -7.0)

Cognitive Behavioral Therapy for Insomnia: p <0.001, Mixed Models Analysis

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 6 months post-intervention. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cognitive Behavioral Therapy for Insomnia	0 of 149 (0%)	0 of 149 (0%)	0 of 149

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38468418Sherwood 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Andrew Sherwood, PhD principal investigator

Duke University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive Behavioral Therapy for Insomnia (CBT-I) in people with Hypertension and Insomnia, run by Duke University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Blood Pressure During the Nighttime Sleep Period (time frame: Baseline, 6 months post-intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04009447, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.