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NCT00867451 · ClinicalTrials.gov registry record · Phase 1
Improving Sleep and Daytime Functioning Among Children Diagnosed With Attention Deficit Hyperactivity Disorder (ADHD)
A Phase 1 study, sponsored by Children's Hospital Medical Center, Cincinnati.
- Completed
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT00867451: Completed Phase 1 study, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT00867451 is a Phase 1 study that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 8 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00867451, a Phase 1 study, has completed, sponsored by Children's Hospital Medical Center, Cincinnati.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study Summary
This study will test the efficacy of a systematic, multi-modal intervention protocol designed to improve sleep functioning and subsequent alleviation of daytime cognitive and behavioral difficulties among children diagnosed with ADHD. It is hypothesized that children receiving behavioral and (if necessary) pharmacologic interventions targeting sleep will display improvement on objective and subjective sleep measures, neuropsychological tests, and teacher-, and parent-ratings of ADHD behaviors.
Primary Outcome
Data was gathered via actigraphy. Data was gathered on a nightly basis for one week at baseline and at week five. Data presented is the mean nightly value (in minutes) for that week.
Interventions
- DRUG Melatonin
- BEHAVIORAL Sleep Intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2010-01 |
| Est. Completion | 2011-07 |
| Phase | Phase 1 |
What the finished NCT00867451 record still lists
NCT00867451 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 2 interventions - of which Melatonin is the first listed.
NCT00867451 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00867451 about?
NCT00867451 is a clinical study titled "Improving Sleep and Daytime Functioning Among Children Diagnosed With Attention Deficit Hyperactivity Disorder (ADHD)". This study will test the efficacy of a systematic, multi-modal intervention protocol designed to improve sleep functioning and subsequent alleviation of daytime cognitive and behavioral difficulties among children diagnosed with ADHD. It is hypothesized that children receiving behavioral and (if nec...
What is the current status of trial NCT00867451?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2010-01. Estimated completion is 2011-07.
What interventions are being tested in trial NCT00867451?
The interventions under investigation include: Melatonin (DRUG), Sleep Intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT00867451?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00867451's enrollment target sits among peer trials
8 1959th of 2000 higher than 29 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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