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

Cox Health Systems26 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Attention Deficit Hyperactivity Disorder INSOMNIA

Interventions

DaytranaDRUG

Daytrana patch 10-30 mg administered once daily for 9hr

DaytranaDRUG

Daytrana 10-30 mg worn once daily for 10 hr wear

DaytranaDRUG

Daytrana 10-30 mg worn once daily for 11 hr

Daytrana

Eligibility

Sex: ALLMin age: 6 YearsMax age: 12 Years

Medical Language ↔ Plain English

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 (1)

Pediatric Neurology of the Ozarks

Springfield, Missouri, United States

Outcomes

Primary Outcomes

Sleep Latency

Measure by daily subject sleep diary

Time frame: 9 weeks

Data from ClinicalTrials.gov

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