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Can better sleep lower heart risks for hypertension patients?

NCT ID NCT04009447

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at 149 adults with high blood pressure and insomnia to understand how poor sleep might raise the risk of heart disease. Researchers used a sleep therapy called CBT-I to see if improving sleep could lower nighttime blood pressure. The goal was to learn more about the link between sleep quality and heart health.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

149 people

The number who actually took part.

Started

Feb 2020

Finished

Jan 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

30 to 60 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

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