A Clinical Trial of Iron Supplementation for Youth With ADHD and Restless Sleep
A legfontosabb adatok
- Hol
- Baltimore (Egyesült Államok)A helyszín megnézése
- Fázis
- 1/2. fázis
Neked szólhat?
Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.
- 8 és 18 év között vagy?
Forrás: NCT07061470: ki vehet részt
Helyszínek itt: Egyesült Államok
- Kennedy Krieger InstituteBaltimore, Egyesült ÁllamokContact: Alison E Pritchard, PhDNo longer taking part
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Azonosító
- NCT07061470
- A regiszteradat frissítve
- 2026. május 4.
- Eredeti leírás
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:A teljes eredeti leírásKevesebb
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
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
Bevonási feltételek: clinically diagnosed with ADHD; have blood ferritin level below 50ng/mL; have parent- or self-reported restless sleep.
Kizáró feltételek: having received Iron supplementation treatment within the past 3 months; presence of any chronic medical or genetic condition that could impact iron metabolism; presence of moderate to severe Obstructive Sleep Apnea; having blood ferritin level indicative of anemia that requires immediate treatment.