Can better sleep lower heart risks for hypertension patients?
NCT ID NCT04009447
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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149 people
The number who actually took part.
- Started
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Feb 2020
- Finished
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Jan 2025
- Lead sponsor
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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
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30 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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
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Duke University Medical Center
Durham, North Carolina, 27710, United States
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