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

Cox Health Systems

Status: Completed

Conditions: Attention Deficit Hyperactivity Disorder; INSOMNIA

Treatments: Drug: Daytrana

Study type: Interventional

Funder types: Other

Identifiers

NCT00989950

shire IND#54,732 (Other Identifier)

cox002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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26 participants in 4 patient groups

Daytrana 9 hr wear

Experimental group

Treatment:

Drug: Daytrana

Drug: Daytrana

Drug: Daytrana

Drug: Daytrana

Daytrana 10 hr wear

Experimental group

Treatment:

Drug: Daytrana

Drug: Daytrana

Drug: Daytrana

Drug: Daytrana

Daytrana 11 hr wear

Experimental group

Treatment:

Drug: Daytrana

Drug: Daytrana

Drug: Daytrana

Drug: Daytrana

Daytrana 12 hr wear

Experimental group

Treatment:

Drug: Daytrana

Drug: Daytrana

Drug: Daytrana

Drug: Daytrana