Cognitive behavioral therapy and trazodone for insomnia phenotypes with high blood pressure
Official title: 1/2 Cognitive Behavioral Therapy and Trazodone Effects on Sleep and Blood Pressure in Insomnia Phenotypes Based on Objective Sleep Duration: A Sequential Cohort/Randomized Controlled Trial
Funded at Pennsylvania State Univ Hershey Med Ctr · NIH-11635771 · Data updated 2026-11-12
A clinical study tests how CBT-I and the sleep drug trazodone work for adults with insomnia and high blood pressure, focusing on a specific sleep duration pattern.
Quick facts
| Grant type | NIH-funded research |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Pennsylvania State Univ Hershey Med Ctr NIH-funded |
| Lab location | 1 site (Hershey, United States) |
| Project start | July 1, 2023 |
| Project end | June 30, 2028 |
| Funding year | 2026 |
| Award (this year) | $274,986 |
| NIH project number | 3UH3HL161342-04S1 |
| Project ID | NIH-11635771 on NIH RePORTER |
Who could benefit from this research
✓Could help
Adults with insomnia and elevated blood pressure, particularly those with the ISS phenotype or those not responding to CBT-I.
✕Less likely to help
Some participants may not experience improvements in sleep or blood pressure or may experience side effects from trazodone.
What this research studies
This project targets adults with insomnia and elevated blood pressure, comparing two insomnia treatments: cognitive-behavioral therapy for insomnia (CBT-I) and trazodone. It first studies groups with short sleep duration versus normal sleep duration to see who benefits most. After a 4-site observational cohort, the study moves into a placebo-controlled randomized trial involving 600 participants to test effectiveness and safety. The investigators will measure sleep and blood pressure changes, along with cortisol levels, to understand treatment responses. The goal is to tailor insomnia care for people at risk of cardiovascular and metabolic problems.
Why it matters
Potential benefit: If successful, patients with insomnia and high blood pressure could receive more effective, personalized treatment options.
How similar studies have gone: Preliminary data suggest differential responses to CBT-I and trazodone across insomnia phenotypes, supporting further study.
Where this research is happening
-
Pennsylvania State Univ Hershey Med Ctr
Hershey, United States Active
Researchers
- Principal investigator: Vgontzas, Alexandros N — Pennsylvania State Univ Hershey Med Ctr
- Study coordinator: Vgontzas, Alexandros N
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About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.