The MY NAP Study
“Is your child on medication for a diagnosis of ADHD and having trouble sleeping?”
What is the MY NAP study about?
An international research team is undertaking a study to look at the effectiveness of Melatonin in helping children who have a diagnosis of ADHD, are currently treated with stimulant medication, and are experiencing sleep difficulties, particularly in getting to sleep.
This study is designed in a way that it can help provide information for individuals, and also group information. This information could be useful in determining if melatonin has a significant effect on sleep for your child.
Results from this study can be given to your doctor to help in treatment planning for your child.
This study is funded by the National Health and Medical Research Council (NHMRC).
Hyperactivity Disorder (ADHD)
ADHD is a complex disorder involving difficulties with hyperactivity, concentration and attention.
Children with ADHD often have difficulty sleeping with problems trying to settle down in the evening. This can be complicated by the medications used to treat ADHD (such as with stimulants like Ritalin, Dexamphetamine).
What is Melatonin?
Melatonin is a natural hormone that is produced by a part of the brain, called the pineal gland. It is often described as the hormone of sleep and it helps to regulate other hormones and maintain the body’s circadian rhythm. The body produces melatonin each night as it gets dark to promote sleep and “re-set” the body clock. In some health conditions, insufficient melatonin is produced, and melatonin supplements can help.
Melatonin has been used in children to help with their sleep from time to time, however the scientific research has not decided whether there is a true effect seen in children with ADHD.
One of the best ways is to see whether your child sleeps better with melatonin, or a placebo (inactive medication).
Who is eligible to
take part in this study?
- Children between the ages of 6 – 17 years;
- Who have a diagnosis of ADHD;
- Who are treated for their ADHD with Stimulants such as Ritalin,
- Who have trouble sleeping, i.e. take at least 45 mins to get to sleep at least three nights a week.
- Children who are already on Melatonin can participate in the study, but they will have to stop their melatonin use at the start of the first phase, as described below.
- Children with some other conditions that also affect sleep, eg. Autism, brain injury, seizure disorder or sleep apnea, may be unsuitable for the study.
What would be involved?
If you are interested in taking part in the study, please contact Dr. Jane Nikles via email: firstname.lastname@example.org or telephone (mobile): 0408 599 033 for further information and to confirm your child’s eligibility.
A referral from your doctor – your G.P or Paediatrician - is required for the study. If you are interested in participating, you will be asked to make an appointment with your doctor, and the study team will contact them to ensure they are fully informed about the study.
In the first phase, you would be asked to initially complete some questionnaires and be given information about healthy sleeping habits. Your child’s sleeping activity would be monitored for two weeks.
At the end of the two weeks, your child would be given the medication (either melatonin or a placebo) for 1 week blocks, for six weeks. All participating children will receive both melatonin and the placebo. During the six weeks, you would be asked to keep a sleep diary and complete more questionnaires. Your child will wear an activity watch to help us measure their sleep activity.
A report will be generated and sent to your referring doctor detailing your child’s individual responsiveness to melatonin. This can be used to guide ongoing treatment decisions.
There will be follow-up contacts three and twelve months after this.
Who are we?
The research team is part of an international group of researchers from Lady Cilento Children’s Hospital, Brisbane; The University of Queensland, Brisbane; and The University of Alberta, Canada. It is led by Dr Jane Nikles (UQ), Prof Geoff Mitchell (UQ), A/Prof Honey Heussler (Lady Cilento Children’s Hospital) and Dr Hugh Senior (UQ).
The project has been granted the following ethics approvals:
UQ HREC – 2012000999
For further information,
Dr. Jane Nikles
Mob: 0408 599 033
Prof Geoff Mitchell
A/Prof Honey Heussler