Is your child struggling with insomnia? Join our pediatric sleep study exploring an investigational treatment to help children fall and stay asleep. Expert care, no-cost participation, and personalized support for your child.
Frequently asked questions
What age does my child need to be?
Your child must be between 10 and under 18 years old at the time of enrollment.
What kind of sleep problems qualify?
Your child must have had trouble falling or staying asleep—or waking too early—at least 3 nights a week for 3 months or more, despite good sleep habits or non-medication treatments.
How is the sleep issue measured?
Your child must score above 16 on a standard sleep questionnaire (SDSC) that measures difficulty with sleep initiation or maintenance.
Can children with conditions like ADHD or autism participate?
Yes, if your child has a diagnosed neurodevelopmental disorder (like ADHD or ASD), they may qualify as long as any stimulant medication has been stable for at least 4 weeks.
Are there pregnancy-related requirements for participants?
Yes. If your child can become pregnant, they must test negative for pregnancy and agree to use approved birth control throughout the study and for a short period afterward.
What else is required to join?
You must sign a caregiver consent form, and your child may need to give written assent depending on their age and local regulations. You’ll also need to agree to all study visits and procedures.
What the clinic will ask you
Encore Medical Research's own pre-screening questions. You answer them when you apply — they go to the clinic only.
- Do you or your child feel that poor sleep is affecting their mood, school, or daily activities?YesNoUnsure
- Does the sleep problem continue even though your child has a regular bedtime routine and good sleep habits?UnsureNoYes
- Does this happen at least 3 nights each week?UnsureNoYes
- Does your child have enough time and a proper environment for sleep, but still struggles with sleep?YesUnsureNo
- Does your child have trouble falling asleep, staying asleep, or wakes up too early and can’t fall back asleep?YesNoUnsure
- Does your child weigh less than 25 kg (55 lbs)?UnsureNoYes
- Has this sleep problem been going on for 3 months or more?UnsureYesNo
- Has your child ever been diagnosed with sleep-related breathing problems (like sleep apnea)?UnsureNoYes
- Has your child used other sleep or mental health medications in the past 3 weeks (unless for ADHD/ASD and taken in the morning)?UnsureNoYes
- Is your child between 10 and 17 years old?UnsureYesNo
- Is your child’s sleep problem not caused by medication (like stimulants or antidepressants)?UnsureYesNo
