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NCT06281756 · ClinicalTrials.gov registry record · Early Phase 1
Cognitive Behavioral Therapy and Trazodone Effects on Sleep and Blood Pressure in Insomnia
A Early Phase 1 study of Insomnia and Blood Pressure, sponsored by Milton S. Hershey Medical Center.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 600
- Enrollment target
- 4
- Study locations
NCT06281756: Recruiting Early Phase 1 study of Insomnia and Blood Pressure, sponsored by Milton S. Hershey Medical Center.
NCT06281756 is a Early Phase 1 study of Insomnia and Blood Pressure that is actively recruiting participants, run by Milton S. Hershey Medical Center. The registered enrollment target is 600 participants, above the 166-participant average among 151 other Insomnia trials with a reported enrollment target (261% higher). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06281756, a Early Phase 1 study of Insomnia and Blood Pressure, is actively recruiting participants, sponsored by Milton S. Hershey Medical Center.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 600 participants
- Enrollment target
- 4
- Study locations
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.
Primary Outcome
Based on Insomnia Severity Index (ISI) published criteria; 0-28, with 0 being mild and 28 being severe
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 |
What NCT06281756 shows while recruiting
NCT06281756 is an interventional study that assigns participants to a tested intervention. The registered 600 participants enrollment target is mid-sized for trials with a published cap, above the 166-participant average among 151 other Insomnia trials with a reported enrollment target (261% higher).
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.
NCT06281756 reports a single indexed study location in Pennsylvania, Colorado, Quebec.
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.
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).
Who is sponsoring clinical trial NCT06281756?
This trial is sponsored by Milton S. Hershey Medical Center, which has 396 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Insomnia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06281756's enrollment target sits among peer trials
600 8th of 151 higher than 143 of 151 other Insomnia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Insomnia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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