Sleep Quality and Mechanisms of Cardiovascular Risks in Adults With Hypertension
Completed · Not applicable
Conditions studied: Hypertension, Insomnia
In brief
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.
Key facts
- Study ID
- NCT04009447
- Run by
- Duke University
- People needed
- 149
- Starts
- 2020-02-14
- Expected to finish
- 2025-01-02
- Last updated by the study team
- 2026-02-23
Who can join
Age: 30 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Duke University Medical Center — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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