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Cognitive Behavioral Therapy and Trazodone Effects on Sleep and Blood Pressure in Insomnia
NCT06281756 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Trazodone
- BEHAVIORAL Cognitive Behavioral Treatment for Insomnia (CBT-I)
Study Locations (4)
Pennsylvania
- Penn State University — Hershey
- University of Pittsburgh — Pittsburgh
Colorado
- National Jewish Health — Denver
Quebec
- Université Laval — Québec
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 600 participants |
| Start Date | 2024-03-20 |
| Est. Completion | 2028-05-31 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06281756
The ClinicalTrials.gov registry entry for NCT06281756 describes a study currently listed as recruiting. It is categorized as Early Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 600 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Milton S. Hershey Medical Center, which has 277 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 5 conditions, with Insomnia appearing as the primary indexed condition, and to 3 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06281756 reports 4 study locations spanning 3 distinct geographic areas — top geographies include Pennsylvania, Colorado, Quebec. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06281756 about?
NCT06281756 is a clinical study titled "Cognitive Behavioral Therapy and Trazodone Effects on Sleep and Blood Pressure in Insomnia". 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...
What is the current status of trial NCT06281756?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 600 participants. The study started on 2024-03-20. Estimated completion is 2028-05-31.
What conditions does trial NCT06281756 study?
This clinical trial studies the following conditions: Insomnia, Blood Pressure, Insomnia Chronic, Insomnia, Primary, Blood Pressure, High. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06281756?
The interventions under investigation include: Placebo (OTHER), Trazodone (DRUG), Cognitive Behavioral Treatment for Insomnia (CBT-I) (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06281756?
This trial is sponsored by Milton S. Hershey Medical Center, which has 277 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06281756 being conducted?
This trial has 4 study locations across Colorado, Pennsylvania, Quebec. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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