SHADES Mechanistic Trial (SHADES)
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ClinicalTrials.gov Identifier: NCT06041581 |
Recruitment Status :
Enrolling by invitation
First Posted : September 18, 2023
Last Update Posted : June 4, 2024
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Condition or disease | Intervention/treatment | Phase |
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Insomnia Insomnia Chronic Insomnia, Primary Sleep Disturbance Sleep Disorder Cardiovascular Diseases Heart Diseases Coronary Artery Disease Stroke Autonomic Dysfunction Systemic Inflammatory Response Metabolic Disease | Behavioral: Sleep Healthy Using The Internet (SHUTi) Behavioral: Telephonic CBT-I Behavioral: Face-to-Face CBT-I Other: Active Control: Sleep Education/Hygiene, Symptom Monitoring, and Usual Primary Care | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 200 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Strengthening Hearts by Addressing DisruptEd Sleep (SHADES) Mechanistic Trial |
Actual Study Start Date : | April 25, 2024 |
Estimated Primary Completion Date : | July 31, 2027 |
Estimated Study Completion Date : | July 31, 2027 |
Arm | Intervention/treatment |
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Experimental: SHADES Intervention
The SHADES intervention is a 6-month, modernized, collaborative care intervention in which a multidisciplinary team delivers established insomnia treatments consistent with patient preference. It uses a stepped, flexible, treat-to-target approach that harnesses technology to maximize access to and convenience of effective treatments and to minimize personnel, training, and space requirements. Our Intervention Team consists of an insomnia clinical specialist, a clinical behavioral sleep medicine and CBT-I delivery expert, a sleep research/medicine expert, and the patients' primary care providers. Treatments to be delivered are CBT-I in different modalities - internet, phone, and face-to-face - all of which are empirically supported.
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Behavioral: Sleep Healthy Using The Internet (SHUTi)
Sleep Healthy Using The Internet (SHUTi) is an empirically supported internet intervention. It uses a fully automated, interactive, multimedia format to deliver six 45-minute sessions, the structure and content of which mirror face-to-face CBT-I. Session content includes sleep restriction, stimulus control, sleep hygiene, cognitive restructuring, and relapse prevention. Each session has the same structure: objectives, sleep diary and homework review, new intervention material, homework assignment, and summary. SHUTi is enhanced through interactive features, including personalized goal setting, graphical feedback based on inputted symptoms, animations and illustrations to enhance comprehension, quizzes to test user knowledge, patient vignettes, and video-based expert explanation. Patients also receive tailored sleep recommendations and feedback based on the sleep diary data they enter into the program. We provide basic tablet skills training and tablets with data plans when needed. Behavioral: Telephonic CBT-I Telephonic CBT-I will be delivered by our insomnia clinical specialist following the highly cited treatment manual by Perlis et al. (2005). Sessions will occur weekly for 30-50 minutes. Telephonic CBT-I will be delivered from a central location - the Insomnia Clinical Specialist's office. Telephonic CBT-I has been shown to be acceptable, feasible, and effective, with effect sizes similar to face-to-face CBT-I. Behavioral: Face-to-Face CBT-I Face-to-face CBT-I will be delivered by our insomnia clinical specialist following the highly cited treatment manual by Perlis et al. (2005). Sessions will occur weekly for 30-50 minutes. Face-to-face CBT-I will be delivered at the Insomnia Clinical Specialist's office. CBT-I is the clear first-line treatment for insomnia. |
Active Comparator: Active Control
Active Control (AC) consists of sleep education and hygiene (study staff), symptom monitoring (study staff), and usual primary care for insomnia (clinical staff).
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Other: Active Control: Sleep Education/Hygiene, Symptom Monitoring, and Usual Primary Care
A designated trial research assistant will have two calls with each AC patient - one 45-minute call on insomnia education and one 45-minute call on sleep hygiene practices. The same research assistant will also call AC patients monthly to assess insomnia symptoms and will notify clinical staff to encourage additional care when indicated. AC patients will receive usual primary care for insomnia. The targeted clinics utilize a team care approach for behavioral health issues, as PCPs are supported by behavioral health clinicians and psychiatrists available for brief counseling and medication management. However, there is no routine screening for insomnia, and behavioral treatment for insomnia is typically limited to sleep hygiene practices. |
- High-Sensitivity C-Reactive Protein (hsCRP) [ Time Frame: Baseline, 6 months ]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.
- Interleukin-6 (IL-6) [ Time Frame: Baseline, 6 months ]A secondary outcome is 6-month change in IL-6 assessed by the validated MSD MULTI-SPOT® 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.
- Pre-Ejection Period (PEP) [ Time Frame: Baseline, 6 months ]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.
- High-Frequency Heart Rate Variability (HF HRV) [ Time Frame: Baseline, 6 months ]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.
- Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, 6 months ]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.
- Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) [ Time Frame: Baseline, 6 months ]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.
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Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06041581
United States, Indiana | |
Department of Psychology, School of Science, IUPUI | |
Indianapolis, Indiana, United States, 46202 |
Principal Investigator: | Jesse C Stewart, Ph.D. | Indiana University |
Responsible Party: | Jesse Stewart, Professor of Psychology, Indiana University |
ClinicalTrials.gov Identifier: | NCT06041581 |
Other Study ID Numbers: |
17650 R01HL165115 ( U.S. NIH Grant/Contract ) |
First Posted: | September 18, 2023 Key Record Dates |
Last Update Posted: | June 4, 2024 |
Last Verified: | June 2024 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Device Product Not Approved or Cleared by U.S. FDA: | Yes |
Product Manufactured in and Exported from the U.S.: | Yes |
Primary Care Internet Interventions Cognitive-Behavioral Therapy for Insomnia Insomnia Cardiovascular Diseases |
Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Autonomic Nervous System Diseases Primary Dysautonomias Cardiovascular Diseases Coronary Artery Disease Heart Diseases Metabolic Diseases Coronary Disease |
Myocardial Ischemia Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Sleep Disorders, Intrinsic Dyssomnias Nervous System Diseases Mental Disorders Neurologic Manifestations |