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Strengthening Hearts by Addressing DisruptEd Sleep (SHADES) Mechanistic Trial 

Pilot Trial

This mechanistic randomized controlled trial (R01 HL165115) seeks to determine if our modernized collaborative care intervention for insomnia improves biological factors (systemic inflammation, autonomic dysfunction, metabolic dysregulation, and proinflammatory gene expression) thought to explain how insomnia promotes cardiovascular disease and if these improvements are due to positive changes in sleep mechanisms.

200 patients with insomnia and elevated CVD risk are being recruited from the primary care clinics of Eskenazi Health, a safety net healthcare system in Indianapolis. 

This is a 5-year study funded by the National Heart, Lung, and Blood Institute Entry

Due to the success of HIV medications (highly effective antiretroviral therapy), people with HIV are living longer, and HIV is now considered to be a chronic disease. Unfortunately, people with HIV have an increased risk of serious non-AIDS events (SNAE) including diabetes, chronic kidney disease, and cardiovascular disease (CVD). The causes of this elevated CVD risk are not fully understood.


The aim of this R21 pilot trial is to determine whether treating insomnia with an internet cognitive-behavioral treatment for insomnia (CBT-I) called Sleep Healthy Using the Internet (SHUTiTM) lowers systemic inflammation in people with HIV.


50 patients with treated HIV and insomnia are being recruited from HIV clinics in Indianapolis. The primary outcome is change in circulating levels of high-sensitivity C-reactive protein (hsCRP), and the secondary outcomes include IL-6, sCD14, and sCD163.


Results of this phase II trial could pave the way to a multicenter phase III trial, which could identify insomnia as a novel treatment target for SNAE prevention and establish the long-term effects of SHUTi on systemic inflammation and SNAE.


This is a 2-year study funded by the National Institute of Mental Health Entry

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