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

Last updated: April 29, 2025
Sponsor: Milton S. Hershey Medical Center
Overall Status: Active - Recruiting

Phase

1

Condition

Stress

Vascular Diseases

Insomnia

Treatment

Cognitive Behavioral Treatment for Insomnia (CBT-I)

Trazodone

Placebo

Clinical Study ID

NCT06281756
STUDY00022285
1UG3HL161342-01A1
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 18 or older

  • Able to read and effectively communicate in English at the United States sites orable to read and effectively communicate in English or French at the Canadian site.

  • Meets criteria for chronic insomnia

  • Body Mass Index (BMI) 18.5 kg/m2 and higher

Exclusion

Exclusion Criteria:

  • Age < 18

  • Unable to read and effectively communicate in English at the United States sites orable to read and effectively communicate in English or French at the Canadian site.

  • Unwilling to share email address/cell phone number to accept survey links.

  • Life time diagnosis of psychotic or bipolar disorder

  • Current use of supplemental oxygen for the treatment of sleep apnea

  • History of severe apnea or an Apnea Hypopnea Index (AHI) ≥15 that is not currentlytreated with Positive Airway Pressure (PAP) therapy, an oral device or an implanteddevice, or was not treated with surgery or weight loss.

  • Started new or changed treatment for sleep apnea in the past three months

  • Does not meet criteria for chronic insomnia

  • Meets criteria for narcolepsy or hypersomnia disorder

  • Meets criteria for circadian rhythm disorder (including night shift work)

  • Unstable medical conditions that would make participation unsafe or unfeasible

  • Falls resulting in hospitalization, significant injury or fracture within past 12months

  • 2 hospitalizations or emergency room visits within past 12 months for chronicconditions

  • Active chemotherapy or radiation therapy for cancer

  • Lifetime diagnoses/treatment of chronic renal failure, hepatic insufficiency,chronic heart failure

  • Does not agree to refrain from other treatments for insomnia beyond what is offeredin this study

  • BMI less than 18.5

  • Substance abuse or dependence in the past 12 months

  • Current use of prescription or over the counter medications taken for sleep greaterthan 2 times per week

  • Current use of systemic corticosteroids or opiate medications

  • Current pregnancy or breastfeeding; plans to get pregnant or unwillingness to usebirth control for the length of the study

  • Current use of medications contraindicated with trazodone

  • Sleep apnea or periodic leg movement disorder as determined by sleep study

  • Blood Pressure levels defined as seated SBP greater than 180 or DBP greater than 110mmHg

  • EKG corrected QT interval greater than or equal to 500 ms

Study Design

Total Participants: 600
Treatment Group(s): 3
Primary Treatment: Cognitive Behavioral Treatment for Insomnia (CBT-I)
Phase: 1
Study Start date:
March 20, 2024
Estimated Completion Date:
May 31, 2028

Connect with a study center

  • Université Laval

    Quebec, G1V 0A6
    Canada

    Active - Recruiting

  • National Jewish Health

    Denver, Colorado 80206-2761
    United States

    Active - Recruiting

  • Penn State University

    Hershey, Pennsylvania 17033
    United States

    Active - Recruiting

  • University of Pittsburgh

    Pittsburgh, Pennsylvania 15213-3203
    United States

    Active - Recruiting

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