Study of the Effect of Individualizing Daytrana Wear-times on Sleep in Children With ADHD

Not Applicable

Completed

• Conditions: INSOMNIA; Attention Deficit Hyperactivity Disorder
• Interventions: Drug: Daytrana

• Registration Number: NCT00989950
• Lead Sponsor: Cox Health Systems

Brief 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.

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.

Study Timeline

• Study First Submitted: 2009-09-30
• Study First Submitted QC: 2009-10-05
• Study First Posted: 2009-10-06
• Study Start: 2009-12
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Results First Submitted: 2012-03-12
• Results First Submitted QC: 2012-05-15
• Results First Posted: 2012-06-14
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-16
• Last Update Posted: 2012-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Daytrana 9 hr wear	Daytrana	-
Daytrana 10 hr wear	Daytrana	-
Daytrana 11 hr wear	Daytrana	-
Daytrana 12 hr wear	Daytrana	-

Primary Outcome Measures

Name	Time	Method
Sleep Latency	9 weeks	Measure by daily subject sleep diary

Trial Locations

Locations (1)

Pediatric Neurology of the Ozarks; 🇺🇸 Springfield, Missouri, United States