Title
Study of the Effect of Individualizing Daytrana Wear-times on Sleep in Children With ADHD
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)
Phase
N/ALead Sponsor
Cox Health SystemsStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Attention Deficit Hyperactivity Disorder INSOMNIAIntervention/Treatment
methylphenidate ...Study Participants
26Methylphenidate 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.
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.
Daytrana patch 10-30 mg administered once daily for 9hr
Daytrana 10-30 mg worn once daily for 10 hr wear
Daytrana 10-30 mg worn once daily for 11 hr
Daytrana 10-30 mg worn once daily for 12 hrs
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
| Event Type | Organ System | Event Term | Group Sequence 1 | Group Sequence 2 | Group Sequence 3 | Group Sequence 4 |
|---|
Measure by daily subject sleep diary
