Abstract
Abstract
Introduction:
Obstructive sleep apnea (OSA) and insomnia are two of the most common sleep disorders worldwide. Both conditions are associated with detrimental health consequences. Participation in clinical trials remains essential in understanding screening, diagnosing and treatment. However, the extent to which minority populations are represented in clinical trials that focus on sleep disorders is not yet known.
Methods:
We queried the Clinicaltrials.gov website, the registry that includes trials conducted in the U.S. and globally to characterize trials (observational and interventional) that focused on OSA and insomnia. All registered trials conducted from 2000 to November 28, 2016 were included.
Results:
Of the 230,894 trials registered in Clinicaltrials.gov, 826 trials were related to sleep disorders. Of the sleep disorders trials, 34% included drugs, 28% included a device, and 20% were behavioral. Half of the trials were completed (54%) and less than 10% were active, but not yet recruiting or recruiting by invitation only. Eighty percent of the trials were treatment related. Of the 826 sleep trials, 21% reported results, and 12% reported information on race/ethnicity enrollment. Overall, 7,321 of participants in these studies were white followed by 1,461 black, 624 Asian, 551 Hispanic, and 283 ‘other or unknown’.
Conclusion:
These results suggest that the number of minority populations in sleep disorders trials are relatively low, specifically compared to the number of trials reported overall. OSA and insomnia treatments are efficacious and effective in the general population. However, the extent to which treatments are effective and utilized by minority populations is not clear; this may in part be related to limited participation in clinical trials. Without appropriate representation in clinical trials, it is difficult to assess which screening, diagnostic, and treatment options work best for minorities, and which factors may influence uptake of treatment. Failure to address this issue may contribute to the increasing disparities in sleep health.
Support (If Any):
Dr. Williams was supported by funding from the NIH K23HL125939
