HERSHEY, Pa. — Researchers at Penn State College of Medicine have been awarded more than $8.5 million by the National Institutes of Health's National Heart, Lung, and Blood Institute. The grant will fund a study on the effects of cognitive behavioral therapy for insomnia (CBT-I) and trazodone, an antidepressant, on sleep and blood pressure in individuals with insomnia. The researchers said they aim to better understand the impact of insomnia on general health and address the need for more personalized treatment options.
“Chronic insomnia affects more than 10% of the general population, yet its diagnosis is currently based solely on subjective complaints,” said Alexandros N. Vgontzas, principal investigator and professor of psychiatry and behavioral health at the College of Medicine. “Currently, treatment options for insomnia are determined by various factors, including the clinician's background, training and personal experience, as well as patient preferences. However, based on years of research, we have identified a specific phenotype called insomnia with objective short sleep duration (ISS), which accounts for 50% of all patients.”
Individuals with ISS have a higher risk of developing cardiometabolic problems such as hypertension, Type 2 diabetes, heart problems and stroke. They also show reduced response to the currently recommended "first-line" treatment, which is CBT-I. According to the researchers, preliminary data suggest that trazodone, a commonly prescribed medication for insomnia, may improve sleep quality, increase total sleep time and lower blood pressure in individuals with ISS.
Vgontzas and his team said they aim to determine the efficacy of CBT-I in adults with ISS compared to those with insomnia and normal sleep duration (INS). The study will involve 600 adults who have elevated blood pressure. Additionally, the researchers will examine the efficacy of trazodone in individuals who do not respond to CBT-I.
This study will be the first to use objective total sleep time as a reliable measure to distinguish between patients with ISS and INS and assess their differential response to CBT-I. Also, it is the first large placebo randomized controlled trial to investigate the efficacy of trazodone — a medication that, despite being the most commonly prescribed sleep-inducing agent by physicians in U.S., has not been studied in terms of its efficacy and potential side effects.
The researchers said they will also explore the effects of CBT-I and trazodone on blood pressure and other pre-clinical cardiometabolic risk factors in adults with elevated blood pressure. Additionally, the researchers will investigate whether the treatment effects of trazodone on sleep duration and blood pressure are mediated by a specific molecular mechanism.
“This groundbreaking study has the potential to revolutionize the conceptualization, diagnosis and treatment of insomnia,” Vgontzas said. “By shedding light on the differential response to CBT-I and exploring the efficacy of trazodone, we aim to provide more personalized and effective treatment options for individuals with insomnia.”
Researchers at the College of Medicine are partnering with colleagues nationally and internationally, including in Pittsburgh; Denver, Colorado; and Quebec, Canada.