Stroke Clinical Trial
— SHADESOfficial title:
Strengthening Hearts by Addressing DisruptEd Sleep (SHADES) Mechanistic Trial
Cardiovascular disease (CVD) is common, deadly, and costly, and adults with insomnia represent a large group of people at elevated risk of developing CVD in the future. This clinical trial will determine if our updated insomnia treatment, called the SHADES intervention, improves CVD factors thought to explain how insomnia promotes CVD and if these improvements are due to positive changes in sleep factors. A total of 200 primary care patients with insomnia and CVD risk factors will be randomized to 6 months of the SHADES intervention (internet, telephonic, and/or face-to-face cognitive-behavioral therapy for insomnia) or the active control condition (sleep education/hygiene, symptom monitoring, and primary care for insomnia). Before and after treatment, participants will complete measurements of the CVD factors (systemic inflammation, autonomic dysfunction, metabolic dysregulation, proinflammatory gene expression) and the sleep factors (insomnia symptoms, sleep onset latency, wake after sleep onset, sleep efficiency). Researchers will test whether the SHADES intervention produces greater improvements in the CVD factors than the active control condition.
Status | Not yet recruiting |
Enrollment | 200 |
Est. completion date | July 31, 2028 |
Est. primary completion date | July 31, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years and older |
Eligibility | Inclusion criteria: 1. Current primary care patient in Eskenazi Health 2. Age =40 years 3. Current insomnia disorder: During screening, ResNet assistants will administer the Insomnia Severity Index (ISI), a validated screener in primary care. Patients who have ISI scores =10 (97% sensitivity, 64% specificity) and remain eligible after ResNet screening will be called by our Insomnia Clinical Specialist, who will administer the Structured Clinical Interview for DSM-5 Sleep Disorders to confirm insomnia disorder. 4. Elevated CVD risk: Elevated CVD risk will be defined as =2 (if 40-59 years) or =1 (if 60+ years) of the following risk factors in the Eskenazi Health EHR in the past 5 years: hypertension, hypercholesterolemia, diabetes, or smoking. Exclusion criteria are: 1. History of clinical CVD: a self-reported CVD diagnosis during screening or any of the following in the patient's electronic health record before enrollment: myocardial infarction, unstable angina, coronary artery disease, cerebrovascular disease, heart failure, percutaneous coronary intervention, or coronary artery bypass graft 2. Sleep disorder diagnosis other than insomnia (e.g., sleep apnea) 3. Continuous positive airway pressure (CPAP) use or a STOP-BANG Questionnaire score =5, which is indicative of high probability of sleep apnea 4. A schedule requiring a usual bedtime earlier than 8:00pm or later than 2:00am or arising time earlier than 4:00am or later than 10:00am 5. Major inflammatory conditions (HIV/AIDS, chronic kidney disease, systemic inflammatory disease, or active cancer) 6. Current pregnancy 7. Severe cognitive impairment (=3 errors on a validated 6-item cognitive screen) 8. History of bipolar disorder or psychosis 9. Acute risk of suicide |
Country | Name | City | State |
---|---|---|---|
United States | Department of Psychology, School of Science, IUPUI | Indianapolis | Indiana |
Lead Sponsor | Collaborator |
---|---|
Indiana University | Eskenazi Health, National Heart, Lung, and Blood Institute (NHLBI), Regenstrief Institute, Inc., University of California, Los Angeles, University of Virginia |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | High-Sensitivity C-Reactive Protein (hsCRP) | The primary outcome is 6-month change in hsCRP assessed by the Human CRP Quantikine ELISA (R&D Systems). hsCRP is a circulating inflammation biomarker that is implicated in the pathophysiology of CVD and is a predictor of future CVD events. | Baseline, 6 months | |
Secondary | Interleukin-6 (IL-6) | A secondary outcome is 6-month change in IL-6 assessed by the validated MSD MULTI-SPOTĀ® Assay System and 5 plex Proinflammatory Panel 1 Human Kit. IL-6, a proinflammatory cytokine that stimulates production of CRP, is moderately correlated with CRP, and is predictive of future CVD events. | Baseline, 6 months | |
Secondary | Pre-Ejection Period (PEP) | A secondary outcome is 6-month change in resting PEP, an index of sympathetic activation, which will be assessed following established guidelines. Autonomic dysfunction measures are predictors of future CVD events. | Baseline, 6 months | |
Secondary | High-Frequency Heart Rate Variability (HF HRV) | A secondary outcome is 6-month change in resting HF-HRV, an index of parasympathetic activation, which will be assessed following established guidelines. Autonomic dysfunction measures are predictors of future CVD events. | Baseline, 6 months | |
Secondary | Hemoglobin A1c (HbA1c) | A secondary outcome is 6-month change in HbA1c. HbA1c will be measured by an immunoturbidimetric method on a Randox Daytona Clinical Analyzer. HbA1c is the gold standard measure of glycemia. HbA1c is a predictor of CVD events. | Baseline, 6 months | |
Secondary | Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) | A secondary outcome is 6-month change in HOMA-IR. HOMA-IR will be computed from fasting glucose (glucose oxidase method on a Randox Daytona Clinical Analyzer) and insulin (two antibody immunoassay on a Roche cobas e411 Analyzer). HOMA-IR is an established index of insulin resistance that correlates highly with the invasive euglycemic clamp. HOMA-IR is a predictor of CVD events. | Baseline, 6 months |
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