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NCT04009447Completed

Sleep Quality and Mechanisms of Cardiovascular Risks in Adults With Hypertension

Source: ClinicalTrials.gov · Last updated 23 Feb 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
149 (actual)
First submitted
3 Jul 2019
Start date
14 Feb 2020
Primary completion date
2 Jan 2025
Lead sponsor
Duke University
NCT number
NCT04009447

What you commit to

  • Study type: Interventional
  • Participants enrolled: 149
  • From 14 Feb 2020 to the primary completion date, 2 Jan 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Antihypertensive medication use
  • Cardiovascular medications
  • Previously diagnosed moderate or severe obstructive sleep apnea
  • Alcohol or drug abuse within 12 months

Other illness

  • Uncontrolled hypertension (screening office BP \> 160/100 mm Hg)
  • 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
  • Active diagnosis of psychosis, bipolar disorder
  • Diabetes
  • Psychiatric Hospitalization within the past 12 months
  • 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

Other

  • Severe obesity defined by BMI\>40 kg/m2
  • Pacemakers
  • Atrial fibrillation
  • Current pregnancy
  • 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)
  • Exposure-based PTSD treatment
  • Inability to comply with the assessment procedures or inability to provide informed consent.

Who the study is looking for

  • 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

Age in the registry: 30 years to 60 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Duke University Medical Center
Coordinator of this site? Confirm its status
DurhamUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.