N/A Completed N=149 Other

Sleep Quality and Mechanisms of Cardiovascular Risks in Adults With Hypertension

Hypertension · Insomnia

Source: ClinicalTrials.gov NCT04009447 ↗

Enrolled (actual)

149

Serious AEs

0.0%

Results posted

Feb 2026

Primary outcomePrimary: Change in Blood Pressure During the Nighttime Sleep Period — -2.48; -1.90 mmHg — p=0.002

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.

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

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.

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.