Insomnia Therapy for Cardiovascular Disease Improvement

(SHADES Trial)

Overseen By Matthew Schuiling, B.A.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: Clinical CVD, Sleep apnea, Inflammatory conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new insomnia treatment can reduce risks associated with heart disease. Participants will receive either the SHADES insomnia treatment or an active control treatment, which includes sleep education and monitoring. The trial will explore whether improving sleep can positively impact factors such as inflammation and metabolism linked to heart disease. Ideal candidates are those struggling with insomnia and have risk factors for heart disease, such as high blood pressure or diabetes, but no history of heart disease itself. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research on sleep and heart health.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that Cognitive Behavioral Therapy for Insomnia (CBT-I), the main treatment in the SHADES program, is generally safe and well-tolerated. CBT-I has been widely used and studied, with few negative effects reported. In past studies, patients experienced better sleep without major side effects. The SHADES program employs CBT-I through various methods, including online, phone, and in-person sessions, to help treat insomnia.

Although specific data on side effects from the SHADES program is limited, the use of CBT-I suggests it is safe. Prospective participants should know that the SHADES program focuses on improving sleep with treatments safely used in many situations. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SHADES intervention for insomnia because it takes a modernized, patient-centered approach that offers more flexibility than traditional treatments. Unlike standard care, which often involves fixed in-person sessions, SHADES uses a stepped, treat-to-target strategy that incorporates technology, such as internet and phone-based cognitive behavioral therapy for insomnia (CBT-I). This makes effective treatment more accessible and convenient, potentially improving adherence and outcomes for patients with insomnia and related cardiovascular issues.

What evidence suggests that this trial's treatments could be effective for improving cardiovascular disease factors in patients with insomnia?

Research shows that cognitive-behavioral therapy for insomnia (CBT-I), a key part of the SHADES intervention in this trial, can improve sleep quality. Studies have found that better sleep can help reduce risks related to heart disease, such as inflammation and metabolism problems. The SHADES intervention provides CBT-I through online and phone sessions, making participation easier and more convenient. Early results suggest that treating insomnia this way may improve heart health by addressing these risk factors. Meanwhile, participants in the Active Control arm will receive sleep education and hygiene, symptom monitoring, and usual primary care for insomnia. ^{1 4 6 7 8}

Who Is on the Research Team?

Jesse C Stewart, Ph.D.

Principal Investigator

Indiana University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have been diagnosed with insomnia.

I am 40 years old or older.

Current primary care patient in Eskenazi Health

Exclusion Criteria

I do not have major inflammation or active cancer.

I have a history of cardiovascular disease or related conditions.

You use a CPAP machine regularly or have a high score on the STOP-BANG Questionnaire.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the SHADES intervention or active control condition for insomnia over 6 months

6 months

Internet, telephonic, and/or face-to-face sessions

Follow-up

Participants are monitored for changes in CVD factors and sleep factors after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Active Control
• SHADES intervention

Trial Overview 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.

How Is the Trial Designed?

Group I: SHADES Intervention Experimental Treatment 3 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 Control Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Eskenazi Health

Collaborator

Trials

14

Recruited

3,700+

Regenstrief Institute, Inc.

Collaborator

Trials

27

Recruited

98,500+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

University of California, Los Angeles

Collaborator

Trials

1,594

Recruited

10,430,000+

University of Virginia

Collaborator

Trials

802

Recruited

1,342,000+

Published Research Related to This Trial

Cognitive Behavioral Treatment for Insomnia (CBTI) is highly effective, showing significant improvements in various sleep measures across 87 randomized controlled trials involving 3724 patients, with an overall effect size of 0.98 for insomnia severity.

Face-to-face CBTI treatments with at least four sessions are more effective than shorter or self-help interventions, and the effectiveness of CBTI remains consistent across different patient demographics and comorbid conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive and behavioral therapies in the treatment of insomnia: A meta-analysis. van Straten, A., van der Zweerde, T., Kleiboer, A., et al.[2022]

The STEP-YA program is a new online educational intervention designed to help young adult cancer survivors (YACS) improve their insomnia symptoms and mood, addressing their unique challenges after cancer treatment.

This phase 2 trial will assess the effectiveness of STEP-YA in 74 YACS with insomnia, comparing outcomes between those who receive additional coaching and those who do not, with results expected to inform future treatment strategies for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep Treatment Education Program for Young Adult Cancer Survivors (STEP-YA): Protocol for an Efficacy Trial. Michaud, AL., Bice, B., Miklos, E., et al.[2023]

Cognitive Behavioral Therapy for Insomnia (CBT-I) significantly improved insomnia severity, sleep quality, fatigue, and daytime sleepiness in adults with chronic heart failure over a one-year period, compared to a self-management education program.

The study involved 175 participants and demonstrated that CBT-I also enhanced physical function, as measured by the six-minute walk distance, indicating its effectiveness in managing sleep-related issues in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavioral therapy for insomnia has sustained effects on insomnia, fatigue, and function among people with chronic heart failure and insomnia: the HeartSleep Study. Redeker, NS., Yaggi, HK., Jacoby, D., et al.[2022]

Citations

1. reporter.nih.gov reporter.nih.gov/search/7GfqJwcbHkGBC5rEQoE2AQ/project-details/10906748

Project Details - NIH RePORTER This mechanistic study will determine if our updated insomnia treatment called SHADES improves biological factors thought to explain how insomnia promotes CVD ...

2. med.virginia.edu med.virginia.edu/bht/2023/10/26/jesse-stewarts-shades-trial-can-insomnia-treatment-reduce-cardiovascular-disease-risks-3m-funds-study-to-find-out/

Jesse Stewart's SHADES trial: Can insomnia treatment ... The aim of the SHADES trial is to discover whether the treatment of insomnia can reduce the risk for cardiovascular disease.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06041581?term=AREA%5BConditionSearch%5D(%22Primary%20Dysautonomias%22)%20AND%20AREA%5BBasicSearch%5D(gene%20therapy)&rank=9

Study Details | NCT06041581 | SHADES Mechanistic Trial This clinical trial will determine if our updated insomnia treatment , called the SHADES intervention, improves CVD factors thought to explain how insomnia ...

4. withpower.com withpower.com/trial/phase-sleep-initiation-and-maintenance-disorders-1-2024-6493d

Insomnia Therapy for Cardiovascular Disease ... This clinical trial will determine if our updated insomnia treatment, called the SHADES intervention, improves CVD factors thought to explain how insomnia ...

5. ctv.veeva.com ctv.veeva.com/study/shades-mechanistic-trial

SHADES Mechanistic Trial - ClinicalTrials.Veeva Researchers will test whether the SHADES intervention produces greater improvements in the CVD factors than the active control condition.

6. reporter.nih.gov reporter.nih.gov/search/7N-BmyA0pUuI3fZFvO2_7Q/project-details/10906748

Strengthening Hearts by Addressing DisruptEd Sleep ... This mechanistic study will determine if our updated insomnia treatment called SHADES improves biological factors thought to explain how insomnia promotes CVD ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02513017

Insomnia and Cardiovascular Diseases: Influence of ... The study will provide experimental evidence of the extent to which improved sleep quantity and quality reduce the risk of cardiovascular diseases, and the SCI ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5577359/

Insomnia and Risk of Cardiovascular Disease - PMC In the Sleep Heart Health Study, a prospective study of 631 participants with insomnia symptoms, 48% of participants also had a sleep duration of < 6 h on PSG.