One million adults in the U.S. receive mechanical ventilation in a hospital ICU annually. While in the ICU, as many as 80 percent of these individuals experience delirium, a syndrome of acute brain dysfunction. Delirium predisposes patients to longer ICU and hospital stays and increased risk of death. Delirium is also associated with long-term complications including cognitive impairment and dementia.
Individuals with delirium experience a sudden change in mental status, often acting confused, disoriented or distracted. Individuals experiencing delirium could become overactive, agitated and restless. They may have rapid emotional changes, have trouble concentrating and often experience hallucinations or anxiety.
“No effective drug for delirium exists so there is great need for nonpharmacological therapies to prevent or manage delirium,” said study co-principal investigator Babar Khan, M.D., M.S., of Regenstrief Institute and IU School of Medicine. “We are conducting this study to firmly establish that music reduces delirium in ICU patients who are mechanically ventilated, with the goal of music listening as anti-delirium therapy becoming the standard of care for patients in ICUs across the country.”
A past president of the American Delirium Society, Dr. Khan is the developer of the CAM-ICU-7, an easy-to-use delirium severity evaluation tool. CAM-ICU-7 is being used in the study to score delirium on a zero (no delirium) to 7 (severe) scale to provide objectivity to brain failure assessment. This information is vital not only for current and future brain health management by clinicians, but also for use in future clinical studies by researchers. He has also developed the post-critical care model for ICU survivors.
In the current music to decrease delirium study, 160 mechanically ventilated adults, 50 years of age or older, are being randomized to one of two groups within 72 hours of ICU admission. Those in the music arm of the study receive a dose of slow tempo (60 to 80 beats per minute) instrumental music through noise-canceling headphones for one hour twice daily for seven days. The other arm receives a placebo consisting of a silent audio track administered in the same manner and duration. In addition to twice daily delirium assessments, pain and anxiety will be evaluated daily.
The primary outcome of improving delirium is measured by the number of days patients are alive, not comatose and free of delirium during the seven days of exposure to music or silence.
For both groups a specially designed computer application (app), which has been pilot tested by the Regenstrief, IU and Mayo researchers, tracks the length and frequency of listening sessions. For those in the music arm of the study, the app also gathers data about music selection from an extensive playlist.
Three months after hospital discharge, the effects of exposure to music on cognition, as measured by memory, attention, information processing, speed and executive cognitive function of recipients of music versus silent track will be assessed as well as study participants’ mood and anxiety.
“As a secondary outcome of the study, we are exploring the downstream effects of relaxing, slow-tempo music on brain health outcomes that matter to ICU survivors,” said study co-investigator Sikandar Khan, D.O. He is co-program director of the COVID-19 Recovery Program for Older Adults at Regenstrief Institute and director of the Indiana University Health Intensive Care Unit (ICU) Survivor Center.
The clinical trial, “Decreasing delirium through music in critically ill, mechanically ventilated older adults,” is supported by the National Institutes of Health’s National Institute on Aging. The paper describing the study protocol, “Decreasing delirium through music listening (DDM) in critically ill, mechanically ventilated older adults in the intensive care unit: a two-arm, parallel-group, randomized clinical trial,” is published in the peer-reviewed open access journal Trials. In addition to co-senior author Dr. Babar Khan and co-senior author Linda Chlan, PhD, R.N., Mayo Clinic; and Regenstrief Investigator Dr. Sikandar Khan, authors on the Trials paper are Salwa Moiz, MBBS, Kiran Naqvi, MBBS, and Lori Rawlings, BSN, R.N., all of Regenstrief Institute; corresponding author Sarah Seyffert, M.D., Matthew Coghlan, M.D., Anthony J. Perkins, M.S., Sujuan Gao, PhD, all of IU School of Medicine; Patil Balozian, M.D., Jason Nasser, M.D., Emilio Abi Rached, M.D., Yasser Jamil, M.D., all of Lebanese American University; J. Downs Hunter, Area 10 Labs and Annie Heiderscheit, PhD, Augsburg University.
Babar Khan, M.D., M.S.
In addition to his appointment as a Regenstrief Institute research scientist and as associate director of the Indiana University Center for Aging at Regenstrief Institute, Babar Khan, M.D., M.S., is an IU School of Medicine professor of medicine and the Floyd and Reba Smith Professor of Respiratory Disease.
Sikandar Khan, D.O., M.S.
Sikandar Khan is a Regenstrief Institute research scientist and an assistant professor of medicine at Indiana University School of Medicine who focuses on delirium in the Intensive Care Unit and non-pharmacological approaches to the prevention and treatment of this devastating brain failure.
About Regenstrief Institute
Founded in 1969 in Indianapolis, Regenstrief Institute is a local, national and global leader dedicated to a world where better information empowers people to end disease and realize true health. A key research partner to Indiana University, Regenstrief and its research scientists are responsible for a growing number of major healthcare innovations and studies. Examples range from the development of global health information technology standards that enable the use and interoperability of electronic health records to improving patient-physician communications, to creating models of care that inform practice and improve the lives of patients around the globe.
Sam Regenstrief, a nationally successful entrepreneur from Connersville, Indiana, founded the institute with the goal of making healthcare more efficient and accessible for everyone. His vision continues to guide the institute’s research mission.
About IU School of Medicine
IU School of Medicine is the largest medical school in the U.S. and is annually ranked among the top medical schools in the nation by U.S. News & World Report. The school offers high-quality medical education, access to leading medical research and rich campus life in nine Indiana cities, including rural and urban locations consistently recognized for livability.