A clinical trial is any research study that evaluates interventions to prevent, detect, diagnosis, or treat a disease or disorder. In a clinical trial, human participants (or groups of participants) are assigned to one or more interventions to assess the results on health outcomes.
Clinical Trials are important in discovering new treatments to prevent, detect, diagnosis, or treat narcolepsy. It is the only process to bring new pharmacological drugs and treatments forward for approval to use within the narcolepsy community. Without the clinical trials, there is a risk that individuals could be given treatments which have no advantage, waste time, and could even be harmful to one’s health. If a treatment has no benefit, or has serious side effects, the treatment may not be further developed.
WUN is collaborating with Boston Children’s Hospital (PI Dr. Kiran Maski) to develop a screening tool to identify children and adolescents with narcolepsy and idiopathic hypersomnia in the community. We hope to develop and validate this Pediatric Hypersomnia Screening Tool for use in schools and health care settings. Diagnostic delays for pediatric hypersomnia conditions are common and often results in academic and social difficulties for children and adolescents. We hope this tool will both raise awareness of narcolepsy and prompt referrals to appropriate pediatric specialists for faster diagnoses. This study is funded by the American Sleep Medicine Foundation and Coverys Community Health Care Foundation.
Who can participate: We are looking for otherwise healthy patients between the ages of 8-18 years who are awaiting diagnostic testing with a sleep study (polysomnography and multiple sleep latency test) for the diagnosis of Narcolepsy or Idiopathic Hypersomnia.
What will participants have to do? Participants will be asked to fill out a survey online that will take no longer than 10 minutes, and then complete an additional 2 minute follow-up survey one week later. We will require you sign a waiver so we can obtain final sleep study results.
The study provides a $10 gift card as a token of appreciation. If you are interested in participating in this study or would like more information, please contact Elaina Little at Elaina.Little@childrens.harvard.edu or call 617-919-6212.