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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 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.

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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.

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

FieldValue
Enrollment Target 600 participants
Start Date 2024-03-20
Est. Completion 2028-05-31
Phase Early Phase 1

Sponsor

Milton S. Hershey Medical Center

396 total trials

What the Registry Record Tells You About NCT06281756

The ClinicalTrials.gov registry entry for NCT06281756 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 600 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 166-participant average among 151 other Insomnia trials with a reported enrollment target (261% higher). The listed sponsor is Milton S. Hershey Medical Center, which has 396 total studies on file at ClinicalTrials.gov.

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 4 study locations spanning 3 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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