Effects of Cognitive Behavioral Therapy and Trazodone on Sleep and Blood Pressure in Insomnia
Cognitive Behavioral Therapy and Trazodone Effects on Sleep and Blood Pressure in Insomnia Phenotypes Based on Objective Sleep Duration: A Sequential Cohort/Randomized Controlled Trial
This study is testing whether Cognitive Behavioral Therapy and trazodone can improve sleep quality and blood pressure in people with insomnia who either sleep less or have normal sleep duration.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Milton S. Hershey Medical Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 4 sites (Denver, Colorado and 3 other locations) |
| Trial ID | NCT06281756 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who meet the criteria for chronic insomnia and have a Body Mass Index (BMI) of 18.5 kg/m2 or higher.
Not a fit: Patients under 18, those with untreated severe sleep apnea, or individuals with a lifetime diagnosis of psychotic or bipolar disorder may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective treatment strategies for insomnia, reducing associated health risks like hypertension.
How similar studies have performed: Other studies have shown promising results with cognitive behavioral therapy and pharmacological treatments for insomnia, indicating that this approach is supported by existing research.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Denver, Colorado and 3 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.