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

Summary

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

Description

Eligibility

Age range

8–18 years

Sex

All

Healthy volunteers

No

Interventions

• Dietary Supplement
  Ferrous Sulfate

  Dosing of the iron supplement will be based on weight.

• Other
  Placebo

  Placebo pills will be provided to participants in the placebo arm

Location