NIH-funded research NIH-funded research

Behavioral therapy and trazodone for insomnia types that affect sleep time and blood pressure

Official title: 2/2 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 University of Pittsburgh at Pittsburgh · NIH-11168708 · Data updated 2026-11-12

This research will compare cognitive behavioral therapy and the medication trazodone to help adults with insomnia and high blood pressure sleep more and lower their blood pressure.

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Quick facts

Grant typeNIH-funded research
Study typeNIH-funded research
Funding institutionUniversity of Pittsburgh at Pittsburgh
NIH-funded
Lab location1 site (Pittsburgh, United States)
Project startJuly 1, 2023
Project endJune 30, 2028
Funding year2025
Award (this year)$440,448
NIH project number5U24HL161359-03
Project IDNIH-11168708 on NIH RePORTER

Who could benefit from this research

Could help

Adults (age 18 and older) who have chronic insomnia and elevated blood pressure and can attend one of the study sites are the intended participants.

Less likely to help

People without insomnia, without elevated blood pressure, or those unwilling to undergo sleep testing, therapy sessions, or medication would likely not benefit or be eligible.

What this research studies

You would first join a four-site program where your sleep is measured objectively to see if you have short or normal sleep duration. Everyone receives cognitive behavioral therapy for insomnia (CBT-I) and we track sleep time, blood pressure, and stress-hormone markers. People who do not improve after CBT-I may be randomized to take trazodone or a placebo to see if the medication helps them more. The study follows participants over time with clinic visits and objective sleep and blood-pressure measurements.

Why it matters

Potential benefit: If successful, this work could show which treatment better restores sleep and lowers blood pressure for specific insomnia types, enabling more personalized care.

How similar studies have gone: CBT-I is widely recommended and helps many people, but smaller pilot data suggest trazodone may better increase objective sleep time and lower blood pressure in the short-sleep insomnia phenotype where CBT-I may work less well.

Where this research is happening

  • University of Pittsburgh at Pittsburgh
    Pittsburgh, United States
    Active

Researchers

  • Principal investigator: Wisniewski, Stephen R — University of Pittsburgh at Pittsburgh
  • Study coordinator: Wisniewski, Stephen R

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.