Study of the Effect of Individualizing Daytrana Wear-times on Sleep in Children With ADHD
Daytsleep
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)
2 other identifiers
interventional
26
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2009
CompletedFirst Posted
Study publicly available on registry
October 6, 2009
CompletedStudy Start
First participant enrolled
December 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedResults Posted
Study results publicly available
June 14, 2012
CompletedJuly 19, 2012
July 1, 2012
1.2 years
September 30, 2009
March 12, 2012
July 16, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sleep Latency
Measure by daily subject sleep diary
9 weeks
Study Arms (4)
Daytrana 9 hr wear
EXPERIMENTALDaytrana 10 hr wear
EXPERIMENTALDaytrana 11 hr wear
EXPERIMENTALDaytrana 12 hr wear
EXPERIMENTALInterventions
Daytrana patch 10-30 mg administered once daily for 9hr
Eligibility Criteria
You may qualify if:
- ADHD without significant comorbidity
You may not qualify if:
- Cardiac disorder
- Hypertension
- Thyroid disease
- Glaucoma
- History of sudden death, motor tics and/or Tourette's syndrome
- Hypersensitivity to methylphenidate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pediatric Neurology of the Ozarks
Springfield, Missouri, 65807, United States
Related Publications (1)
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.
PMID: 22115000RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Small sample size, did not permit an examination of more specific differences among patch wear time conditions. Small sample size resulted in weaker randomization to patch wear time sequences that was not completely balanced in baseline covariates.
Results Point of Contact
- Title
- Arie Ashkenasi, MD
- Organization
- CoxHealth
Study Officials
- PRINCIPAL INVESTIGATOR
arie ashkenasi
pediatric neurology of the ozarks
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Staff Neurologist
Study Record Dates
First Submitted
September 30, 2009
First Posted
October 6, 2009
Study Start
December 1, 2009
Primary Completion
February 1, 2011
Study Completion
February 1, 2011
Last Updated
July 19, 2012
Results First Posted
June 14, 2012
Record last verified: 2012-07