A Clinical Trial of Iron Supplementation for Youth With ADHD and Restless Sleep (NCT07061470)
RestEaze: A Novel Wearable Device and Mobile Application to Improve the Diagnosis and Management of Restless Sleep in Pediatric Patients With Attention Deficit/Hyperactivity Disorder, Phase II
🩺 Plain-English Summary (8th-Grade Level)
The goal of this clinical trial is to learn if iron supplementation works to restless sleep in youth with ADHD. A second goal is to learn if iron supplementation helps to ease ADHD symptoms. The main questions that this trial aims to answer are: Does 3 months of iron supplementation treatment improve parent- and youth self-reported sleep difficulties more than placebo? Does 3 months of iron supplementation treatment improve sleep as measured by actigraphy more than placebo? Does 3 months of iron supplementation treatment improve parent-reported and/or objectively measured attention more than placebo? Researchers will compare over-the-counter iron supplementation treatment to a placebo (a look-alike substance that contains no drug) to see if iron supplementation works to treat sleep difficulties in youth with ADHD. Participants will: * Take iron supplements every day for 3 months * Visit the clinic once before treatment begins and once at the end of treatment to complete tests and rating scales related to sleep and attention * Wear motion-monitoring leg bands while sleeping for one 2-week period before treatment begins and one 2-week period at the end of treatment
Who can join: Review the eligibility criteria below.
Location: Kennedy Krieger Institute — Baltimore, Maryland
Age range: 8 Years to 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Kennedy Krieger Institute — Baltimore, Maryland
📞 Contact the Study Coordinator
Phone: (443) 904-2488
Email: pritchard@kennedykrieger.org
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.