A Clinical Trial of Iron Supplementation for Youth With ADHD and Restless Sleep
Public ClinicalTrials.gov record NCT07061470. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT07061470
- Recruitment status
- Not yet recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 70 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 8 Years to 18 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 28, 2027
- Primary completion
- Jul 30, 2027
- Completion
- Jul 30, 2027
- Last update posted
- May 3, 2026
2027
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Kennedy Krieger Institute | Baltimore | Maryland | 21231 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07061470, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 3, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07061470 live on ClinicalTrials.gov.