Actively Recruiting

Early Phase 1
Age: 18Years +
All Genders
NCT06281756

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

Led by Milton S. Hershey Medical Center · Updated on 2025-11-10

600

Participants Needed

4

Research Sites

219 weeks

Total Duration

On this page

Sponsors

M

Milton S. Hershey Medical Center

Lead Sponsor

N

National Heart, Lung, and Blood Institute (NHLBI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 or older
  • Able to read and effectively communicate in English at the United States sites or able 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
Not Eligible

You will not qualify if you...

  • Age under 18
  • Unable to read and effectively communicate in English at the United States sites or able to read and effectively communicate in English or French at the Canadian site
  • Unwilling to share email address or cell phone number to accept survey links
  • Lifetime diagnosis of psychotic or bipolar disorder
  • History of severe apnea or an Apnea Hypopnea Index (AHI) ≥15 not currently treated with Positive Airway Pressure (PAP) therapy, oral or implanted device, 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 making participation unsafe or unfeasible
  • Falls resulting in hospitalization, significant injury or fracture within past 12 months
  • Two hospitalizations or emergency room visits within past 12 months for chronic conditions
  • Active chemotherapy or radiation therapy for cancer
  • Lifetime diagnosis or treatment of chronic renal failure, hepatic insufficiency, chronic heart failure
  • Does not agree to refrain from other insomnia treatments beyond study offerings
  • BMI less than 18.5
  • Substance abuse or dependence in the past 12 months
  • Current use of prescription or over-the-counter sleep medications more than twice per week
  • Current use of systemic corticosteroids or opiate medications
  • Current pregnancy, breastfeeding, plans to get pregnant, or unwillingness to use birth control during the study
  • Current use of medications contraindicated with trazodone
  • Sleep apnea or periodic leg movement disorder as determined by sleep study
  • Blood pressure levels with seated systolic BP greater than 180 or diastolic BP greater than 110 mmHg
  • EKG corrected QT interval greater than or equal to 500 ms

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 4 locations

1

National Jewish Health

Denver, Colorado, United States, 80206-2761

Actively Recruiting

2

Penn State University

Hershey, Pennsylvania, United States, 17033

Actively Recruiting

3

University of Pittsburgh

Pittsburgh, Pennsylvania, United States, 15213-3203

Actively Recruiting

4

Université Laval

Québec, Quebec, Canada, G1V 0A6

Actively Recruiting

Loading map...

Research Team

C

Carrie Criley

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here