SHADES Mechanistic Trial

NCT06041581 | Enrolling By Invitation DMC FDA Device

• 2 other identifiers: 17650R01HL165115
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Insomnia; Insomnia Chronic; Insomnia, Primary; Sleep Disturbance; Sleep Disorder; Cardiovascular Diseases; Heart Diseases; Coronary Artery Disease; Stroke; Autonomic Dysfunction; Systemic Inflammatory Response; Metabolic Disease

Keywords

Primary Care; Internet Interventions; Cognitive-Behavioral Therapy for Insomnia; Insomnia; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Interleukin-6 (IL-6)

  Baseline, 6 months

• Pre-Ejection Period (PEP)

  Baseline, 6 months

• High-Frequency Heart Rate Variability (HF HRV)

  Baseline, 6 months

• Hemoglobin A1c (HbA1c)

  Baseline, 6 months

• Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)

  Baseline, 6 months

Study Arms (2)

SHADES Intervention

EXPERIMENTAL

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.

Behavioral: Sleep Healthy Using The Internet (SHUTi); Behavioral: Telephonic CBT-I; Behavioral: Face-to-Face CBT-I

Active Control

ACTIVE COMPARATOR

Active Control (AC) consists of sleep education and hygiene (study staff), symptom monitoring (study staff), and usual primary care for insomnia (clinical staff).

Other: Active Control: Sleep Education/Hygiene, Symptom Monitoring, and Usual Primary Care

Interventions

Sleep Healthy Using The Internet (SHUTi) BEHAVIORAL

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.

SHADES Intervention

Telephonic CBT-I BEHAVIORAL

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.

SHADES Intervention

Face-to-Face CBT-I BEHAVIORAL

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.

SHADES Intervention

Active Control: Sleep Education/Hygiene, Symptom Monitoring, and Usual Primary Care OTHER

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.

Active Control

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Eskenazi Health: collaborator
• Regenstrief Institute, Inc.: collaborator
• University of Virginia: collaborator
• University of California, Los Angeles: collaborator

Study Sites (1)

Department of Psychology, School of Science, IUPUI

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Parasomnias; Sleep Wake Disorders; Cardiovascular Diseases; Heart Diseases; Coronary Artery Disease; Stroke; Primary Dysautonomias; Metabolic Diseases

Interventions

Hygiene

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Autonomic Nervous System Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Public Health; Environment and Public Health

Study Officials

• Jesse C Stewart, Ph.D.

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychology

Study Record Dates

• First Submitted: September 11, 2023
• First Posted: September 18, 2023
• Study Start: April 25, 2024
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: July 14, 2025

Record last verified: 2025-07

Locations

US (1)