NIH-funded research NIH-funded research

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 typeNIH-funded research
Study typeNIH-funded research
Funding institutionPennsylvania State Univ Hershey Med Ctr
NIH-funded
Lab location1 site (Hershey, United States)
Project startJuly 1, 2023
Project endJune 30, 2028
Funding year2026
Award (this year)$274,986
NIH project number3UH3HL161342-04S1
Project IDNIH-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

Related research

Other NIH-funded projects on the same topics.

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.