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Title:
Sleep and Neurocognitive Function in Childhood Acute Lymphoid Leukemia Survivors
Protocol Number:
J1578
Phase:
NULL
Physician:
Kathy Ruble
Sites:
Johns Hopkins Kimmel Cancer Center in Baltimore
Purpose:
This research study is being done to see if there is any relationship between sleep and cognitive abilities. We will also see if symptoms of anxiety or depression have a relationship to sleep. We are also studying how well establish questionnaires about sleep work in childhood lymphoid leukemia survivors who are school aged. In addition we want to test the use of two devices that will monitor sleep in the home environment.
Eligibility:
Inclusion:1. History of treatment for Acute Lymphoid Leukemia with or without cranial radiation.2. Currently age greater than 8 to less than 13 years; 3. Off-therapy at least 6 months 4. Signed informed consent. 5. Patients with existing diagnosis of Attention Deficit will included but will not take medication on the day of testingExclusion: 1. Inability to speak English; 2. Diagnosis of Intellectual Developmental Disorder (example Down’s syndrome) or Pervasive Developmental Disorder (example Autism). 3. Patients currently treated for SDB with CPAP will not be included.4. Patients currently taking medications for sleep (except over the counter medication) will not be included.
Treatment:
The study will be completed in two parts. First, you will have a visit in the oncology clinic to see if the device that is worn on the forehead to measure sleep is the appropriate size. If the fit is good you will receive instructions on using the device for two nights at home, as well as instructions on wearing the sleep watch, this visit will take approximately 30 minutes. After you have completed the two nights of in home sleep monitoring with the devices you will have an appointment at the Kennedy Krieger Institute School. You will return the sleep monitors at this time and answer questions about what it was like to use the devices.The second part of the study will be completed in one visit,at least one parent and child will be asked to report to the Kennedy Krieger Institute School. The child will be asked to complete paper and pencil tests as well as a computer generated test. The tests will look at how the child uses their memory and solves problems and will take about 1 ½ hours to complete.Parents will be asked to complete questionnaires about their child's sleep and mood. The visit will take a total of about 3 hours. If the questionnaires indicate that a child has a significant sleeping problem we will refer you to the sleep clinic at Kennedy Krieger for evaluation. This evaluation will not be part of the study procedure, any costs at the sleep clinic will be billed to your insurance. We will ask if you are willing to give us permission to access medical records from the sleep clinic. If after completing the questionnaire concerning your child’s mood you are concerned about anxiety or depression we will refer you to a social worker for further evaluation. This evaluation would not be part of the study procedure.
Population:
Pediatric
Last Update
03/05/2019 05:03 AM