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OpenTrials
Completed

NCT Number: NCT00989950

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

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.

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Key information

Conditions

Attention Deficit Hyperactivity Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Dyssomnias Insomnia Mental Disorders Nervous System Diseases Neurodevelopmental Disorders Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pediatric Neurology of the Ozarks

Springfield, Missouri, 65807, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Daytrana

Drug

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

Other names: methylphenidate transdermal system

Primary outcomes

  1. Sleep Latency

    Time frame: 9 weeks

    Measure by daily subject sleep diary

Sponsors and collaborators

Lead sponsor

Cox Health Systems

Other

Registry information

Official study 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)

Acronym: Daytsleep

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Oct 6, 2009
Registry last updated
Jul 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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