Status:
ENROLLING_BY_INVITATION
SHADES Mechanistic Trial
Lead Sponsor:
Indiana University
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Eskenazi Health
Conditions:
Insomnia
Insomnia Chronic
Eligibility:
All Genders
40+ years
Phase:
NA
Brief Summary
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 determ...
Detailed Description
Cardiovascular disease (CVD) affects nearly 1 in 2 U.S. adults, is the #1 killer of men and women, burdens disadvantaged groups, and has costs greater than any other condition. While these statistics ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Current primary care patient in Eskenazi Health
- Age ≥40 years
- 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.
- 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:
- 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
- Sleep disorder diagnosis other than insomnia (e.g., sleep apnea)
- Continuous positive airway pressure (CPAP) use or a STOP-BANG Questionnaire score ≥5, which is indicative of high probability of sleep apnea
- 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
- Major inflammatory conditions (HIV/AIDS, chronic kidney disease, systemic inflammatory disease, or active cancer)
- Current pregnancy
- Severe cognitive impairment (≥3 errors on a validated 6-item cognitive screen)
- History of bipolar disorder or psychosis
- Acute risk of suicide
Exclusion
Key Trial Info
Start Date :
April 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06041581
Start Date
April 25 2024
End Date
July 31 2027
Last Update
July 14 2025
Active Locations (1)
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1
Department of Psychology, School of Science, IUPUI
Indianapolis, Indiana, United States, 46202