Trial results for a study investigating the impact of sleep quality on cardiovascular risks in adults with hypertension were posted on ClinicalTrials.gov on 2026-02-23. The study found that Cognitive Behavioral Therapy for Insomnia (CBT-I) led to a mean reduction of 2.48 mmHg in nighttime blood pressure.
Background
Hypertension, or high blood pressure, is a major risk factor for cardiovascular disease. Concurrently, insomnia is a common sleep disorder that can negatively impact overall health. This study aimed to explore the potential mechanisms linking insomnia to an increased risk of cardiovascular disease in patients already diagnosed with hypertension. Understanding this relationship is crucial for developing comprehensive management strategies that address both conditions, potentially improving cardiovascular outcomes.
Trial design
This completed study, designated as Phase NA, enrolled 149 participants to investigate conditions including Hypertension and Insomnia. The trial's objective was to elucidate the potential mechanisms responsible for the increased risk of cardiovascular disease among patients with hypertension and comorbid insomnia. The intervention examined was Cognitive Behavioral Therapy for Insomnia (CBT-I).
Key results
The trial reported several key measurements for the Cognitive Behavioral Therapy for Insomnia group:
- Change in Blood Pressure During the Nighttime Sleep Period:
- Mean change of -2.48 mmHg.
- Mean change of -1.90 mmHg.
- Change in Sleep During the Nighttime Sleep Period as Measured by Sleep Diary: Mean change of 6.9 percentage of time asleep.
- Change in Sleep During the Nighttime Sleep Period as Measured by Actigraphy: Mean change of 1.4 percentage of time asleep.
- Changes in Insomnia Severity as Measured by the Insomnia Severity Index (ISI): Mean change of -7.9 score on a scale.
- Change in Awake Blood Pressure:
- Mean change of -1.38 mmHg.
- Mean change of -1.96 mmHg.
- Change in Nighttime Blood Pressure Dip Percentage:
- Mean change of 0.90 percentage points.
- Mean change of 1.80 percentage points.
- Change in Vascular Endothelial Function: Mean change of 1.41 percentage of dilation.
- Change in Arterial Stiffness: Mean change of 0.09 m/s.
- Change in Lipid Profile - HDL (High-Density Lipoprotein), LDL (Low-Density Lipoprotein), and Triglycerides: Mean change of -1.82 mg/dL.
Key analyses using Mixed Models Analysis yielded the following p-values:
- For Systolic blood pressure (SBP): p-value 0.002.
- For Diastolic blood pressure (DBP): p-value 0.001.
- For an unspecified outcome: p-value 0.001.
- For an unspecified outcome: p-value 0.173.
- For an unspecified outcome: p-value 0.001.
- For Systolic blood pressure (SBP): p-value 0.024.
What this means
The results suggest that Cognitive Behavioral Therapy for Insomnia (CBT-I) may offer benefits for adults with hypertension and comorbid insomnia. The observed reductions in both nighttime and awake blood pressure, alongside improvements in sleep quality and insomnia severity, indicate a potential pathway for managing cardiovascular risk in this population. The statistically significant p-values for systolic and diastolic blood pressure changes further support these findings. These outcomes highlight the importance of addressing sleep disturbances as part of a comprehensive approach to hypertension management.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study titled "Sleep Quality and Mechanisms of Cardiovascular Risks in Adults With Hypertension" were posted on 2026-02-23 on clinicaltrials.gov.