Study of the Effect of Individualizing Daytrana Wear-times on Sleep in Children 6-12 Years Old With Attention Deficit Hyperactivity Disorder (ADHD)
Information source: Cox Health Systems
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Attention Deficit Hyperactivity Disorder; Insomnia
Intervention: methylphenidate transdermal system (Drug)
Phase: N/A
Status: Not yet recruiting
Sponsored by: Cox Health Systems Official(s) and/or principal investigator(s):
arie ashkenasi, Principal Investigator, Affiliation: pediatric neurology of the ozarks
Overall contact:
Arie Ashkenasi, MD, Phone: 417-269-1010, Email: arie.ashkenasi@coxhealth.com
Summary
Methylphenidate may improve sleep in children with ADHD. By leaving Daytrana
(methylphenidate) patch for a longer time then 9 hours, many children report short sleep
latencies and better quality of sleep.
Clinical Details
Official title: Open Label Study of the Effect of Individualizing Daytrana Wear-times on Sleep in Children 6-12 Years Old With ADHD
Study design: Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Primary outcome: The primary outcome is that longer patch wear times will lead to decreased sleep latency.
Detailed description:
Once the optimal dose of Daytrana that controlled the ADHD symptoms is established. The
patch will be removed 1, 2, and 3 hours before bed time in a random fashion, at weekly
intervals, and parents will keep a sleep diary.
50 patients will be enrolled in order to obtain statistical significance.
Eligibility
Minimum age: 6 Years.
Maximum age: 12 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- ADHD without significant comorbidity
Exclusion Criteria:
- Cardiac disorder
- Hypertension
- Thyroid disease
- Glaucoma
- History of sudden death, motor tics and/or Tourette's syndrome
- Hypersensitivity to methylphenidate
Locations and Contacts
Arie Ashkenasi, MD, Phone: 417-269-1010, Email: arie.ashkenasi@coxhealth.com
Pediatric Neurology of the Ozarks, springfield, Missouri 65807, United States
Additional Information
Starting date: December 2009
Ending date: December 2010
Last updated: October 8, 2009
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