One of the first studies begins to measure real doses of music in the prevention of delirium.
The Regenstrief Institute, Indiana University School of Medicine, and Mayo Clinic clinician-investigators are conducting a multi-site study to establish that music intervention can reduce the likelihood that severely ill older adults, mechanically ventilated in a intensive care unit (ICU) of a hospital develop delirium and may also improve their post-ICU brain health. The study is one of the first to measure the dose of music exposure as researchers continue their pioneering exploration of music’s potential to decrease or even prevent delirium.
One million adults in the US receive mechanical ventilation in a hospital ICU annually. While in the ICU, up to 80 percent of these people experience delirium, a syndrome of acute brain dysfunction. Delirium predisposes patients to longer ICU and hospital stays and a higher risk of death. Delirium is also associated with long-term complications, including cognitive decline and dementia.
People with delirium experience a sudden change in mental status, often acting confused, disoriented, or distracted. People who experience delirium may become hyperactive, agitated, and restless. They may have rapid emotional changes, have trouble concentrating, and often experience hallucinations or anxiety.
"There is no effective drug for delirium, so there is a great need for non-pharmacologic therapies to prevent or manage delirium," said study co-principal investigator Babar Khan, MD, MS, of the Regenstrief Institute and the IU School of Medicine. “We are conducting this study to firmly establish that music reduces delirium in ICU patients receiving mechanical ventilation, with the goal that listening to music as anti-delirium therapy will become the standard of care for patients in ICUs.” of all country".
A former president of the American Delirium Society, Dr. Khan is the developer of CAM-ICU-7, an easy-to-use delirium severity assessment tool. CAM-ICU-7 is being used in the study to rate delirium on a scale from zero (no delirium) to 7 (severe) to provide objectivity to the assessment of brain failure. This information is vital not only for current and future management of brain health 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 study of music to decrease delirium, 160 mechanically ventilated adults, aged 50 years or older, are 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 instrumental music (60 to 80 beats per minute) through noise-canceling headphones for one hour twice a day 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 assessed daily.
The primary outcome of improving delirium is measured by the number of days patients are alive, coma-free, and delirium-free during the seven days of exposure to music or silence.
For both groups, a specially designed computer application (app), which has been tested by Regenstrief, IU and Mayo researchers, tracks the duration and frequency of listening sessions. For those in the music arm of the study, the app also collects data on music selection from an extensive playlist.
Three months after hospital discharge, the effects of music exposure on cognition will be evaluated, as measured by memory, attention, information processing, speed, and executive cognitive function of music recipients versus music recipients. silent track, as well as the mood and anxiety of the study participants.
“As a secondary outcome of the study, we are exploring the downstream effects of relaxing, slow-tempo music on brain health outcomes that are important to ICU survivors,” said study co-investigator Sikandar Khan, DO. He is co-director of the Program. of COVID-19 recovery for older adults at the Regenstrief Institute and director of the Indiana University Health Intensive Care Unit (ICU) Survivor Center.
The clinical trial, “ Reducing Delirium Through Music in Mechanically Ventilated Critically Ill Older Adults ,” is supported by the National Institute on Aging of the National Institutes of Health.
