NCT04932096 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Luther M, Poppert Cordts KM, Williams CN
Sleep disturbances after pediatric traumatic brain injury: a systematic review of prevalence, risk factors, and association with recovery. Sleep. 2020 Oct 13;43(10):zsaa083. doi: 10.1093/sleep/zsaa083.
Poppert Cordts KM, Hall TA, Hartman ME, Luther M, Wagner A, Piantino J, Guilliams KP, Guerriero RM, Jara J, Williams CN
Sleep Measure Validation in a Pediatric Neurocritical Care Acquired Brain Injury Population. Neurocrit Care. 2020 Aug;33(1):196-206. doi: 10.1007/s12028-019-00883-5.
Williams CN, Hartman ME, McEvoy CT, Hall TA, Lim MM, Shea SA, Luther M, Guilliams KP, Guerriero RM, Bosworth CC, Piantino JA
Sleep-Wake Disturbances After Acquired Brain Injury in Children Surviving Critical Care. Pediatr Neurol. 2020 Feb;103:43-51. doi: 10.1016/j.pediatrneurol.2019.08.010. Epub 2019 Aug 26.

Sleep Management And Recovery After Traumatic Brain Injury in Kids (SMARTKids): Evidence for Targeting Sleep to Improve Outcomes

Clinical trial NCT04932096 - References