NIH-funded research NIH-funded research

Cognitive-Behavioral Therapy and Trazodone for Sleep and Blood Pressure in Insomnia Subtypes

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-11416636 · Data updated 2026-11-12

This program tests how CBT-I and trazodone help sleep and blood pressure in adults with insomnia, focusing on those with short sleep duration versus normal sleep duration.

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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 year2026
Award (this year)$455,087
NIH project number5U24HL161359-04
Project IDNIH-11416636 on NIH RePORTER

Who could benefit from this research

Could help

Adults aged 18 and older with insomnia and elevated blood pressure, stratified by ISS or INS sleep duration phenotype.

Less likely to help

Individuals without insomnia or with normal blood pressure elevation or those not meeting phenotype criteria may not benefit.

What this research studies

Insomnia is common and tied to higher risks for heart, metabolism, and mental health issues. The study zeroes in on a insomnia with short sleep duration (ISS) phenotype and compares its treatment response to insomnia with normal sleep duration (INS) when adults also have elevated blood pressure. It starts with a four-site observational cohort, then moves to a placebo-controlled randomized trial to test CBT-I and trazodone in 600 adults. The goal is to see if ISS and INS respond differently to these treatments, with CBT-I as the standard first-line therapy and trazodone as an additional option for non-responders. The research will measure sleep outcomes, blood pressure, and hormonal stress markers to guide future personalized insomnia care.

Why it matters

Potential benefit: If successful, patients with insomnia and high blood pressure could receive more effective, phenotype-guided treatments to improve sleep and cardiovascular health.

How similar studies have gone: Preliminary data suggest differential responses to CBT-I and trazodone by insomnia phenotype, supporting further testing in a larger trial.

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.