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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


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.


Minimum age: 6 Years. Maximum age: 12 Years. Gender(s): Both.


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

Page last updated: August 23, 2015

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