Article title: Pilot Study on the Effect of Ramelteon on Sleep Disturbance After Traumatic Brain Injury: Preliminary Evidence From a Clinical Trial.
Author: Lequerica A, Jasey N, Portelli Tremont JN, Chiaravalloti ND
Journal: Arch Phys Med Rehabil. 2015 Oct;96(10):1802-9. doi: 10.1016/j.apmr.2015.05.011. Epub 2015 May 28.
Many people with Traumatic Brain Injury (TBI) report sleep disorders, leading to anxiety, depression, and fatigue. These issues are associated with deficits in neurobehavioral, cognitive, and occupational issues. Currently used medications used to treat sleep disorders further complicate cognitive functioning. Benzodiazepines, Tricyclic antidepressant, Trazodone, and anti-histamines carry their own cognitive, sedating, or poor memory effects.
The suprachiasmatic nucleus of the hypothalamus regulates circadian rhythm, and Ramelteon (TAK-375) is a neurohormone that targets melatonin receptors in this nucleus. While Ramelteon is indicated for long-term management of insomnia, and it has minimal chance for addiction, few trials have studied its role in treating insomnia. Clinical trials showed promising results, but Ramelteon’s use in treating sleep disorder in TBI had not yet been studied.
This study tested Ramelteon’s use in treating sleep disorders after TBI. There were 18 participants, each with TBI for at least a month before enrollment. In addition to meeting inclusion criteria, they were screened for other confounding conditions and medications, and discontinued use of other sleep medications for 2 weeks before the study.
The study used a double-blind, placebo controlled crossover design. Participants were grouped into Ramelteon or placebo groups for the first of the study, at which point they were switched into the opposite group for the second half. Electronic accelerometers (actigraphs) were worn to track “sleep onset latency (SOL), number of awakenings, wake time after sleep onset, and total sleep time (TST)”. Participants kept a sleep log, had CNS vital signs recorded, and were measured with the Pittsburgh Sleep Quality Index and Brunel Mood Scale.
Ramelteon was found to significantly increase total sleep time. It was also found to increase time needed to fall asleep, yet this time was not clinically significant. Likely due to the mechanism of action regulating circadian rhythm, those on Ramelteon also went to bed earlier. The study found promising benefit for the use of Ramelteon in treating sleep disorders in TBI. Use of polysomnography instead of actinography would provide more detailed data. Additionally, further research would benefit from a larger sample size.
1: What is the role of the physiatrist in treating TBI?
2: Who else plays a role in treating TBI?
3: Why are sleep disorders particularly troubling for TBI patients?
4: What are some of the side effects with medications currently used to treat sleep disorders?
5: Why was it important to use a double-blind, placebo-controlled crossover design?
6: In addition to use of the actinography, what are some other ideas for how sleep variables can be measured?
7: What benefit would there be if a study recruited participants with more recent injuries?
8: What other methods could be used to manage sleep disorders in TBI?
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