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

200 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of this treatment for improving cardiovascular disease?

Research shows that cognitive behavioral therapy for insomnia (CBT-I) can improve sleep and reduce insomnia severity in people with cardiovascular disease, which may help lower the risk of heart problems. Studies suggest that better sleep through CBT-I can improve heart health by addressing factors like inflammation and stress. ^{1 2 3 4 5}

Is the insomnia therapy safe for humans?

Cognitive behavioral therapy for insomnia (CBTI) has been studied in various groups, including those with other health conditions, and is generally considered safe. The studies did not report significant safety concerns, indicating it is well-tolerated by most people. ^{6 7 8 9 10}

How does the SHADES intervention treatment for insomnia differ from other treatments for cardiovascular disease?

The SHADES intervention is unique because it focuses on improving sleep through cognitive-behavioral therapy (CBT), which is a non-drug approach, potentially reducing cardiovascular disease risk by addressing insomnia without the side effects associated with medications. ^{1 2 3 4 11}

Research Team

Jesse C Stewart, Ph.D.

Principal Investigator

Indiana University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for Insomnia in the Context of Cardiovascular Conditions. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Reducing Coronary Heart Disease Risk Through Treatment of Insomnia Using Web-Based Cognitive Behavioral Therapy for Insomnia: A Methodological Approach. [2021]

3. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Cardiovascular Complications of Sleep Disorders: A Better Night's Sleep for a Healthier Heart / From Bench to Bedside. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

The effect of nurse-led Internet-based cognitive behavioural therapy for insomnia on patients with cardiovascular disease: A randomized controlled trial with 6-month follow-up. [2021]

5. United States 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. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Cognitive and behavioral therapies in the treatment of insomnia: A meta-analysis. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Armodafinil to reduce the sleepiness related side-effects of sleep restriction therapy being used to treat insomnia disorder: An open label clinical trial pilot study compared with historical controls. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Short- and Long-Term Effects of CBT-I in Groups for School-Age Children Suffering From Chronic Insomnia: The KiSS-Program. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

A primary care "friendly" cognitive behavioral insomnia therapy. [2022]

10. Canada pubmed.ncbi.nlm.nih.gov

Sleep Treatment Education Program for Young Adult Cancer Survivors (STEP-YA): Protocol for an Efficacy Trial. [2023]

11. Canada pubmed.ncbi.nlm.nih.gov

Mobile Intervention to Improve Sleep and Functional Health of Veterans With Insomnia: Randomized Controlled Trial. [2022]