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Sleep Disorders in Children With ADHD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00224731
Recruitment Status : Unknown
Verified September 2005 by Hvolby, Allan, M.D..
Recruitment status was:  Recruiting
First Posted : September 23, 2005
Last Update Posted : October 26, 2006
Sponsor:
Information provided by:
Hvolby, Allan, M.D.

Tracking Information
First Submitted Date September 21, 2005
First Posted Date September 23, 2005
Last Update Posted Date October 26, 2006
Study Start Date December 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Sleep Disorders in Children With ADHD
Official Title 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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Cross-Sectional
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition Attention Disorder With Hyperactivity (ADHD)
Intervention Not Provided
Study Groups/Cohorts Not Provided
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. doi: 10.1001/archpedi.162.4.323.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Enrollment
 (submitted: September¬†21,¬†2005)
100
Original Enrollment Same as current
Study Completion Date Not Provided
Primary Completion Date Not Provided
Eligibility Criteria

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 -

Sex/Gender
Sexes Eligible for Study: All
Ages 5 Years to 10 Years   (Child)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Denmark
Removed Location Countries  
 
Administrative Information
NCT Number NCT00224731
Other Study ID Numbers M-2549-03
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor Hvolby, Allan, M.D.
Collaborators Not Provided
Investigators
Principal Investigator: allan hvolby, M.D child psychiatric department, Esbjerg
PRS Account Hvolby, Allan, M.D.
Verification Date September 2005