Study of the Effect of Individualizing Daytrana Wear-times on Sleep in Children With ADHD
Information source: Cox Health Systems
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Attention Deficit Hyperactivity Disorder; INSOMNIA
Intervention: Daytrana (Drug); Daytrana (Drug); Daytrana (Drug); Daytrana (Drug)
Phase: N/A
Status: Completed
Sponsored by: Cox Health Systems Official(s) and/or principal investigator(s):
arie ashkenasi, Principal Investigator, Affiliation: pediatric neurology of the ozarks
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 Attention Deficit Hyperactivity Disorder (ADHD)
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Primary outcome: 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.
25 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
Pediatric Neurology of the Ozarks, Springfield, Missouri 65807, United States
Additional Information
Starting date: December 2009
Last updated: July 16, 2012
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