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| Tracking Information | |||||
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| First Received Date ICMJE | September 21, 2005 | ||||
| Last Updated Date | October 25, 2006 | ||||
| Start Date ICMJE | December 2003 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00224731 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Sleep Disorders in Children With ADHD | ||||
| Official Title ICMJE | Sleep Disorders in Children With ADHD | ||||
| Brief Summary | ADHD is often associated with sleep difficulties. Attention-deficit/hyperactivity disorder (ADHD) is the most common problem presented to children mental health services. The disorder affects approximately 5 % of school-age children. The core symptoms of this disorder include varying degrees of inattention, impulsiveness and restlessness. In addition to the core symptoms, ADHD is associated with other problems (e.g. academic underachievement, poor social relations and sleep disturbances). Despite clinical observations of sleep problems in children with ADHD, there is little empirical research on this topic. The prevalence, type of sleep problems, and significance of these sleep disturbances in children with ADHD remain undocumented. The objective is to determine the relationship of sleep problems to attention deficit/hyperactive disorder, comorbid disorders, and the effect of stimulant treatment. |
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| Detailed Description | |||||
| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Natural History, Cross-Sectional, Defined Population, Prospective Study | ||||
| Condition ICMJE | Attention Disorder With Hyperactivity (ADHD) | ||||
| Intervention ICMJE | |||||
| Study Arms / Comparison Groups | |||||
| Publications * | Hvolby A, Jørgensen J, Bilenberg N. Actigraphic and parental reports of sleep difficulties in children with attention-deficit/hyperactivity disorder. Arch Pediatr Adolesc Med. 2008 Apr;162(4):323-9. | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Enrollment ICMJE | 100 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria: - We will compare a group of children with ADHD, other psychiatric disorder, and a healthy group of children age 5 - 10 Exclusion Criteria: mental retardation - |
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| Gender | Both | ||||
| Ages | 5 Years to 10 Years | ||||
| Accepts Healthy Volunteers | |||||
| Contacts ICMJE |
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| Location Countries ICMJE | Denmark | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00224731 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | M-2549-03 | ||||
| Study Sponsor ICMJE | Hvolby, Allan, M.D. | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Hvolby, Allan, M.D. | ||||
| Verification Date | September 2005 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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