SHADES Mechanistic Trial

Plain-language summary

This study examines the effects of different insomnia treatment approaches (internet-, telephone-, or face-to-face-delivered cognitive behavioral therapy and sleep education) in people with insomnia who are at elevated risk of cardiovascular disease. It enrolls primary care patients aged 40 and older who currently have insomnia disorder. It is a study with no assigned phase and enrolls participants by invitation.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Not Applicable

Status

Enrolling by invitation

Sponsor

Indiana University

Intervention

Sleep Healthy Using The Internet (SHUTi), Telephonic CBT-I, Face-to-Face CBT-I, Active Control: Sleep Education/Hygiene, Symptom Monitoring, and Usual Primary Care

Start date

4/25/2024

Estimated completion

7/31/2027

Countries

United States

Related genes

Locations

• Indianapolis, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine 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