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Insomnia Therapy for Cardiovascular Disease Improvement (SHADES Trial)

N/A

Waitlist Available

Led By Jesse C Stewart, Ph.D.

Research Sponsored by Indiana University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Current insomnia disorder confirmed through Insomnia Severity Index (ISI) and Structured Clinical Interview for DSM-5 Sleep Disorders

Age ≥40 years

Must not have

Major inflammatory conditions or active cancer

History of clinical CVD or specific related conditions

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if an updated insomnia treatment improves CVD factors & if this is due to improved sleep. 200 participants will get either the treatment or an active control. Results will be measured for CVD factors & sleep.

Who is the study for?

This trial is for adults over 40 who are primary care patients at Eskenazi Health with insomnia and a higher risk of heart disease. They must have confirmed insomnia disorder and specific cardiovascular risk factors within the past five years, but can't join if they're pregnant, have severe cognitive issues, acute suicide risk, certain sleep restrictions or disorders like sleep apnea, bipolar disorder or psychosis, use CPAP machines for breathing at night, have had serious heart conditions or inflammatory diseases.

What is being tested?

The SHADES clinical trial tests whether an updated insomnia treatment improves factors related to heart disease. It compares two groups: one receives the SHADES intervention (a mix of internet-based therapy, phone calls and face-to-face sessions) while the other gets standard care including sleep education. The goal is to see if better sleep reduces inflammation and other risks linked to heart problems in those with chronic insomnia.

What are the potential side effects?

While this study focuses on behavioral treatments rather than medications which typically carry more side effects; potential discomforts may include inconvenience from frequent monitoring or stress from discussing personal health issues during therapy sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with insomnia.

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I am 40 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have major inflammation or active cancer.

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I have a history of cardiovascular disease or related conditions.

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I have a sleep disorder that is not insomnia.

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I have significant memory or thinking problems.

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I have a history of bipolar disorder or psychosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

High-Sensitivity C-Reactive Protein (hsCRP)

Secondary study objectives

Hemoglobin A1c (HbA1c)

High-Frequency Heart Rate Variability (HF HRV)

Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: SHADES InterventionExperimental Treatment3 Interventions

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.

Group II: Active ControlActive Control1 Intervention

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

0 / 7Eligibility criteria met