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

Launched by MILTON S. HERSHEY MEDICAL CENTER · Feb 26, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how two different treatments for insomnia affect sleep and blood pressure in people who have trouble sleeping. The treatments being tested are Cognitive Behavioral Therapy for Insomnia (CBT-I), which is a type of talk therapy that helps change habits and thoughts related to sleep, and a low dose of trazodone, which is a medication that can help people sleep better. The researchers want to see if these treatments work differently for people who have short sleep duration compared to those who sleep normally.

To participate in this study, you need to be at least 18 years old and meet certain health criteria, including having chronic insomnia and high blood pressure. Participants will work with the research team to receive one of the treatments and will be monitored for their sleep patterns and blood pressure changes throughout the study. It's important to know that there are specific health conditions that would make you ineligible to participate, such as certain heart problems or severe sleep disorders. This study aims to help doctors choose the best treatment for patients with insomnia based on their individual needs.

Gender

ALL

Eligibility 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
• • 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 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