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

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)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00989950
Acronym
Daytsleep
Enrollment
26
Registered
2009-10-06
Start date
2009-12-31
Completion date
2011-02-28
Last updated
2012-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention Deficit Hyperactivity Disorder, INSOMNIA

Keywords

daytrana, sleep latency, adhd rating scales, ADHD

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.

Interventions

DRUGDaytrana

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

Sponsors

Cox Health Systems
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Sleep Latency9 weeksMeasure by daily subject sleep diary

Countries

United States

Participant flow

Participants by arm

ArmCount
Group Sequence 1
Daytrana 10-30 mg worn 10 hrs, 12 hrs, 9 hrs then 11 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun
6
Group Sequence 2
Daytrana 10-30 mg worn 11 hrs, 9 hrs, 12 hrs then 10 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun
9
Group Sequence 3
Daytrana 10-30 mg worn 9 hrs, 10 hrs, 11 hrs, then 12 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun
4
Group Sequence 4
Daytrana 10-30 mg worn 12 hrs, 11 hrs, 10 hrs, then 9 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun
7
Total26

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003
Randomized PhaseAdverse Event0100
Randomized PhaseProtocol Violation1000

Baseline characteristics

CharacteristicGroup Sequence 1Group Sequence 2Group Sequence 3Group Sequence 4Total
Age, Categorical
<=18 years
6 Participants9 Participants4 Participants7 Participants26 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Attention Deficit Hyperactivity Disorder (ADHD) Subtype
Combined Subtype
4 participants6 participants3 participants7 participants20 participants
Attention Deficit Hyperactivity Disorder (ADHD) Subtype
Other Subtype
2 participants3 participants1 participants0 participants6 participants
Attention Deficit Hyperactivity Disorder Rating Scale-IV Total Score27 Score on scale
STANDARD_DEVIATION 11
37 Score on scale
STANDARD_DEVIATION 9.2
41 Score on scale
STANDARD_DEVIATION 10.2
33.7 Score on scale
STANDARD_DEVIATION 10.6
34.7 Score on scale
STANDARD_DEVIATION 11
Conner's Global Impression-Parent Scale13.7 scores on scale
STANDARD_DEVIATION 7.6
20.1 scores on scale
STANDARD_DEVIATION 6.8
25 scores on scale
STANDARD_DEVIATION 2.3
20.3 scores on scale
STANDARD_DEVIATION 6.7
19.78 scores on scale
STANDARD_DEVIATION 6.8
Sex: Female, Male
Female
2 Participants3 Participants1 Participants1 Participants7 Participants
Sex: Female, Male
Male
4 Participants6 Participants3 Participants6 Participants19 Participants
Sleep Latency22.5 minutes
STANDARD_DEVIATION 12.6
23.3 minutes
STANDARD_DEVIATION 21.8
54.5 minutes
STANDARD_DEVIATION 64.8
50.7 minutes
STANDARD_DEVIATION 12.4
37.8 minutes
STANDARD_DEVIATION 27.9
Sleep Quality4.3 Score
STANDARD_DEVIATION 0.8
4 Score
STANDARD_DEVIATION 1
4 Score
STANDARD_DEVIATION 0.8
3.1 Score
STANDARD_DEVIATION 0.7
3.9 Score
STANDARD_DEVIATION 0.8
Total Sleep Time9.9 hours
STANDARD_DEVIATION 0.9
9.5 hours
STANDARD_DEVIATION 0.9
10.6 hours
STANDARD_DEVIATION 1.2
9.6 hours
STANDARD_DEVIATION 1.8
9.9 hours
STANDARD_DEVIATION 1.8

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —— / —
other
Total, other adverse events
2 / 65 / 91 / 44 / 7
serious
Total, serious adverse events
0 / 60 / 90 / 40 / 7

Outcome results

Primary

Sleep Latency

Measure by daily subject sleep diary

Time frame: 9 weeks

Population: All 26 subjects wore the patches for 9, 10, 11 and 12 hour wears. Results are based upon impact of patch wear time on parameter

ArmMeasureValue (MEAN)
9 hr WearSleep Latency34 minutes
10 hr WearSleep Latency34 minutes
11 hr WearSleep Latency32 minutes
12 hr WearSleep Latency34 minutes
p-value: 0.58895% CI: [0, 233]ANOVA

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026