College of Medicine researchers awarded more than $8 million to study insomnia treatments

Researchers at Penn State College of Medicine have been awarded more than $8.5 million from the National Heart, Lung, and Blood Institute. The funding will be used to conduct a study on the effects of cognitive behavioral therapy for insomnia (CBT-I) and trazodone on sleep and blood pressure in individuals with insomnia. The study aims to address the underrecognized impact of insomnia on general health and 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 of 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, CBT-I. 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 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 innovative study addresses several significant clinical questions. It is 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 although is the most commonly prescribed sleep-inducing agent by physicians in US, it has not been studied in terms of its efficacy and potential side effects.

Researchers 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 down-regulation of the hypothalamic-pituitary-adrenal axis.

“This groundbreaking study has the potential to revolutionize the conceptualization, diagnosis and treatment of insomnia,” said Vgontzas. “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, Pa.; Denver, Colorado and Quebec, Canada.

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