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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the differential responses of patients with insomnia who have short sleep duration compared to those with normal sleep duration when treated with Cognitive Behavioral Therapy for Insomnia (CBT-I) and the medication trazodone. The research aims to determine how these treatments affect sleep quality and blood pressure, which are critical health concerns associated with insomnia. By analyzing the outcomes, the study seeks to develop evidence-based guidelines for clinicians to better tailor insomnia treatments to individual patient needs, potentially improving overall health outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* Age \< 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/cell phone number to accept survey links.
* Life time diagnosis of psychotic or bipolar disorder
* History of severe apnea or an Apnea Hypopnea Index (AHI) ≥15 that is not currently treated with Positive Airway Pressure (PAP) therapy, an oral device or an implanted device, 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 12 months
* 2 hospitalizations or emergency room visits within past 12 months for chronic conditions
* 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 offered in 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 greater than 2 times per week
* Current use of systemic corticosteroids or opiate medications
* Current pregnancy or breastfeeding; plans to get pregnant or unwillingness to use birth 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 110 mmHg
* EKG corrected QT interval greater than or equal to 500 ms

Where it's running

• National Jewish Health
  Denver, Colorado, United States Recruiting
• Penn State University
  Hershey, Pennsylvania, United States Recruiting
• University of Pittsburgh
  Pittsburgh, Pennsylvania, United States Recruiting
• Université Laval
  Québec, Quebec, Canada Recruiting

Study contacts

• Principal investigator: Alexandros Vgontzas, MD — Professor, Psychiatry
• Study coordinator: Carrie Criley
• Email: ccriley@pennstatehealth.psu.edu
• Phone: 717-531-4123

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.