N/A
N=149
Sleep Quality and Mechanisms of Cardiovascular Risks in Adults With Hypertension
Hypertension · Insomnia
Bottom Line
View on ClinicalTrials.gov: NCT04009447 ↗Enrolled (actual)
149
Serious AEs
0.0%
Results posted
Feb 2026
Primary outcome: Primary: Change in Blood Pressure During the Nighttime Sleep Period — -2.48; -1.90 mmHg — p=0.002
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cognitive Behavioral Therapy for Insomnia (CBT-I) (Behavioral)
- Age
- Adult · 30+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Jan 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Blood Pressure During the Nighttime Sleep Period |
-2.48; -1.90 | 0.002 sig |
| PRIMARY Change in Sleep During the Nighttime Sleep Period as Measured by Sleep Diary |
6.9 | <0.001 sig |
| PRIMARY Change in Sleep During the Nighttime Sleep Period as Measured by Actigraphy |
1.4 | 0.173 |
| PRIMARY Changes in Insomnia Severity as Measured by the Insomnia Severity Index (ISI) |
-7.9 | <0.001 sig |
| SECONDARY Change in Awake Blood Pressure |
-1.38; -1.96 | 0.024 sig |
| SECONDARY Change in Nighttime Blood Pressure Dip Percentage |
0.90; 1.80 | 0.208 |
| SECONDARY Change in Vascular Endothelial Function |
1.41 | 0.001 sig |
| SECONDARY Change in Arterial Stiffness |
0.09 | -0.365 |
| SECONDARY Change in Lipid Profile - HDL (High-Density Lipoprotein), LDL (Low-Density Lipoprotein), and Triglycerides |
-1.82; 0.27; 0.68 | 0.024 sig |
| SECONDARY Change in Nighttime Sympathetic Nervous System Activity |
0.01; 0.06 | 0.644 |
| SECONDARY Change in Sleep Fragmentation During the Nighttime Sleep Period |
-1.60 | 0.044 sig |
| SECONDARY Change in Subjective Sleep Quality |
-3.53 | — |
| SECONDARY Change in Clinic Blood Pressure |
-1.75; -0.09 | 0.024 sig |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04009447). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.