🏛️ Verified NIH Record • Updated 2025-11-06

Cognitive Behavioral Therapy and Trazodone Effects on Sleep and Blood Pressure in Insomnia (NCT06281756)

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

🟢 Recruiting Early Phase1 💊 Investigational Drug / Biologic Sponsor: Milton S. Hershey Medical Center

🩺 Plain-English Summary (8th-Grade Level)

Individuals who have insomnia with short sleep duration (ISS) differ from individuals who have insomnia with normal sleep duration (INS) in terms of health risks (i.e., hypertension) and treatment response. This study will examine whether patients with ISS and INS demonstrate a differential response to two common insomnia treatments. One is behavioral, Cognitive Behavioral Therapy for Insomnia (CBT-I). The other is a widely prescribed, non-habit-forming medication, trazodone used at a low dose. The investigators' findings could lead to evidence-based treatment guidelines that help clinicians more effectively match treatments to insomnia patients and reduce associated health problems.

Who can join: Review the eligibility criteria below.

Location: National Jewish Health — Denver, Colorado

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (4 Sites)

  • National Jewish Health — Denver, Colorado
  • Penn State University — Hershey, Pennsylvania
  • University of Pittsburgh — Pittsburgh, Pennsylvania
  • Université Laval — Québec, Quebec

📞 Contact the Study Coordinator

Phone: (717) 531-4123

Email: ccriley@pennstatehealth.psu.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Insomnia clinical trials

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗