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

Primary Purpose

Attention Deficit Hyperactivity Disorder, INSOMNIA

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Daytrana
Daytrana
Daytrana
Daytrana
Sponsored by
Cox Health Systems
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring daytrana, sleep latency, adhd rating scales, ADHD

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Pediatric Neurology of the Ozarks

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Daytrana 9 hr wear

Daytrana 10 hr wear

Daytrana 11 hr wear

Daytrana 12 hr wear

Arm Description

Outcomes

Primary Outcome Measures

Sleep Latency
Measure by daily subject sleep diary

Secondary Outcome Measures

Full Information

First Posted
September 30, 2009
Last Updated
July 16, 2012
Sponsor
Cox Health Systems
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1. Study Identification

Unique Protocol Identification Number
NCT00989950
Brief Title
Study of the Effect of Individualizing Daytrana Wear-times on Sleep in Children With ADHD
Acronym
Daytsleep
Official 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)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cox Health Systems

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder, INSOMNIA
Keywords
daytrana, sleep latency, adhd rating scales, ADHD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Daytrana 9 hr wear
Arm Type
Experimental
Arm Title
Daytrana 10 hr wear
Arm Type
Experimental
Arm Title
Daytrana 11 hr wear
Arm Type
Experimental
Arm Title
Daytrana 12 hr wear
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Daytrana
Other Intervention Name(s)
methylphenidate transdermal system
Intervention Description
Daytrana patch 10-30 mg administered once daily for 9hr
Intervention Type
Drug
Intervention Name(s)
Daytrana
Other Intervention Name(s)
methylphenidate transdermal system
Intervention Description
Daytrana 10-30 mg worn once daily for 10 hr wear
Intervention Type
Drug
Intervention Name(s)
Daytrana
Other Intervention Name(s)
methylphenidate transdermal system
Intervention Description
Daytrana 10-30 mg worn once daily for 11 hr
Intervention Type
Drug
Intervention Name(s)
Daytrana
Intervention Description
Daytrana 10-30 mg worn once daily for 12 hrs
Primary Outcome Measure Information:
Title
Sleep Latency
Description
Measure by daily subject sleep diary
Time Frame
9 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
arie ashkenasi
Organizational Affiliation
pediatric neurology of the ozarks
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pediatric Neurology of the Ozarks
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22115000
Citation
Ashkenasi A. Effect of transdermal methylphenidate wear times on sleep in children with attention deficit hyperactivity disorder. Pediatr Neurol. 2011 Dec;45(6):381-6. doi: 10.1016/j.pediatrneurol.2011.09.003.
Results Reference
result

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

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