The School of Science at IUPUI received a $3 million grant in August from the National Institute of Health for a research venture that seeks to determine whether treatment of insomnia can help mitigate the risk of cardiovascular diseases.
Jesse Stewart, a professor of psychology at IUPUI, is the principal investigator leading the trial, dubbed Strengthening Hearts by Addressing Disrupted Sleep.
Stewart, who previously researched the relationship between depression and cardiovascular diseases, delved deeper into this connection and found symptoms of depression, such as insomnia, are more likely to cause the diseases. Insomnia is the persistent difficulty to fall or stay asleep. The NIH shows insomnia generally affects 10-30% of the world, even rising as high as 50-60% in some studies.
The research team consists of co-investigators from various institutions. The research members from IU School of Medicine are Yelena Chernyak, a specialist in behavioral sleep medicine, Robert Considine, an expert in biomarkers and Babar Khan, a sleep medicine expert. Julie Otte from the IU School of Nursing will provide her expertise in sleep measurement. Biostatistician Wei Wu from the School of Science is responsible for data analysis post-treatment. Krysha MacDonald from Eskenazi Health is tasked with delivering the insomnia treatment. Additionally, the team is currently looking for a cardiologist.
Stewart said the team will begin recruiting 200 patients from IUPUI affiliate Eskenazi Health starting February 2024. The trial will last six months for each patient, and patients can start the trial anytime in the next four years.
Stewart said previous research established people with insomnia have more than 45% greater risk of developing cardiovascular diseases compared to those without insomnia, making it a significant risk factor akin to smoking, high blood pressure and high cholesterol. He said the question of whether treating insomnia can reduce this risk remains unanswered, which is what the trial hopes to uncover.
Patients will undergo screenings such as blood tests, vital sign assessments and interviews, then be assigned to either an intervention or control group. Participants will also receive Fitbits to monitor their sleep patterns throughout the study.
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Stewart said the intervention aspect of the trial will implement Cognitive Behavioral Therapy for Insomnia (CBT-I), an established and highly regarded treatment method. CBT-I aims to reset sleep habits and address negative thought patterns related to sleep, ultimately promoting better sleep quality.
Krysha MacDonald said she will administer this treatment through three stages of intervention. The first stage is a computer-based application called Sleep Healthy Using the Internet (SHUTi), a software that will guide patients from the comfort of their home through interactive media like questionnaires and video guidelines for assistance. The second stage is a telephonic conversation wherein MacDonald will call the patients weekly and address any concerns and monitor progress. The third stage, should the patient face hurdles to progress, would involve the patient physically going to Stewart’s lab in the psychology building at IUPUI and elaborating on their struggles.
“This is my third trial with Jesse over 22 years at Eskenazi Health, and I am very excited for this opportunity,” MacDonald said. “I feel this trial addresses a major issue and it is very important to tackle it and eventually decrease any potential risks.”
Matthew Schuiling, a postdoctoral student at the School of Science, has chosen this trial for his thesis dissertation and is the research coordinator. He said he will assist in various facets of the trial such as recruiting patients, making the questionnaires and prepping the patients before intervention.
“I think sleep is a fascinating thing because there are many unknown factors and it’s a budding field,” Schuiling said. “I’ve previously researched narcolepsy, and insomnia is a very common offshoot of it which needs to be understood to gauge its impact.”
This marks one of the first trials investigating the pathways between insomnia and cardiovascular diseases, Schuiling said, and finding the one significant pathway can open up more treatments down the line for people at risk.
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Stewart said the research team is quantifying the impact of insomnia treatment, through various biomarkers such as inflammation in blood since insomnia is increasingly recognized as an inflammatory disease. He said the team will also monitor blood glucose and insulin resistance, as well as nervous system dysfunction, among other measures.
The final six months of the trial will involve rigorous data analysis, with the hope of confirming a causal relationship between insomnia and cardiovascular diseases, Stewart said.
“The potential success of this trial could pave the way for broader research initiatives and resources dedicated to the control and management of insomnia such as screening for insomnia, treatment options and policy guideline modifications,” Stewart said.