Concussion Study for Preteens and Teens 12 to 18 Who Have Had a Concussion in the Last 2 Weeks

Why are we doing this research?

Cincinnati Children’s is conducting a research study to learn more about changes in how teens sleep as they recover from concussions and to see if we can improve sleep.

Who can participate?

Preteens and teens 12 to 18 years old who have had a concussion in the last 2 weeks may be eligible to participate.

Conditions

  • Concussion - Head Injury

What will happen in the study?

This study includes either 1 or 2 study visits, depending upon whether the injured teen is eligible for 1 or 2 phases of the study (more on eligibility below). Here are some of the things that will happen in this study:

The injured teen will:

  • Be asked to wear a special wristwatch called an actigraph every night for 7 nights that helps keep track of sleep patterns (we will mail it to you)
  • Come with a parent/guardian to Cincinnati Children’s for a study visit
    • At this visit, you or your teen will:
      • Answer questions about your or his/her health and sleep (before and after the concussion)
      • Have a computerized assessment – called ImPACT to measure concussion symptoms
      • Have information from the sleep wristwatch reviewed

For most families, the study will be done after that single office visit. Depending on the injured teen’s sleep and concussion recovery, he/she might be eligible for phase 2 of the study.

If you are in Phase 2 of the study, the injured teen will:

  • Be randomly placed in 1 of 2 study groups, selected like flipping a coin
    • Group A – The injured teen will work one-on-one with a trained sleep specialist to learn skills about how to sleep better, and then wear the wristwatch for another week
    • Group B – The injured teen will not have treatment, but will continue with wearing the wristwatch for another week
  • Come with a parent/guardian for another study visit a week after the first and:
    • Be asked about your or your teen’s concussion symptoms and sleep
    • Have information from the sleep wristwatch reviewed

You will be given a consent form that thoroughly explains all of the details of the study. A member of the study staff will review the consent form with you and will be sure that all of your questions are answered.

What are the good things that can happen from this research?

Being in this study may or may not help you or your teen right now. Most participants will learn more about their sleep during the first phase of the study. If you or your teen participate in the second phase and are randomly selected to receive the sleep treatment, it may help to improve your or his/her sleep. Overall, we think that the results of this study will be helpful to other teens with concussions and may help doctors to give accurate information to teens about sleep following a concussion.

What are the bad things that can happen from this research?

There are very few risks in this study. There will be no drugs, needles, or radiation involved in this study. Possible risks and discomforts will be discussed with potential participants and parents interested in learning more about the study.

Will you/your child be paid to be in this research study?

Participants will receive up to $125 for time and effort.

Contact

Contact Us.Catharine Whitacre
513-636-5360
Catharine.Whitacre@cchmc.org
Behavioral Medicine and Clinical Psychology
Cincinnati Children’s Hospital Medical Center
3333 Burnet Ave.
Cincinnati, OH 45229-3039

Study Doctor

Contact Us.Dean W. Beebe, PhD
Cincinnati Children’s Hospital Medical Center