Study of the Effect of Individualizing Daytrana Wear-times on Sleep in Children With ADHD (Daytsleep)
This study has been completed.
Sponsor:
Cox Health Systems
Information provided by (Responsible Party):
Arie Ashkenasi, MD, Cox Health Systems
ClinicalTrials.gov Identifier:
NCT00989950
First received: September 30, 2009
Last updated: July 16, 2012
Last verified: July 2012
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Results First Received: March 12, 2012
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Crossover Assignment; Masking: Single Blind (Subject); Primary Purpose: Treatment |
| Conditions: |
Attention Deficit Hyperactivity Disorder INSOMNIA |
| Intervention: |
Drug: Daytrana |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| No text entered. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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| No text entered. |
Reporting Groups
| Description | |
|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
Participant Flow for 2 periods
Period 1: Open Label Dose Optimization
| Group Sequence 1 | Group Sequence 2 | Group Sequence 3 | Group Sequence 4 | |
|---|---|---|---|---|
| STARTED | 6 | 9 | 4 | 7 |
| COMPLETED | 6 | 9 | 4 | 7 |
| NOT COMPLETED | 0 | 0 | 0 | 0 |
Period 2: Randomized Phase
| Group Sequence 1 | Group Sequence 2 | Group Sequence 3 | Group Sequence 4 | |
|---|---|---|---|---|
| STARTED | 6 | 9 | 4 | 7 |
| COMPLETED | 5 | 8 | 4 | 7 |
| NOT COMPLETED | 1 | 1 | 0 | 0 |
| Protocol Violation | 1 | 0 | 0 | 0 |
| Adverse Event | 0 | 1 | 0 | 0 |
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| Total | Total of all reporting groups |
Baseline Measures
| Group Sequence 1 | Group Sequence 2 | Group Sequence 3 | Group Sequence 4 | Total | |
|---|---|---|---|---|---|
|
Number of Participants
[units: participants] |
6 | 9 | 4 | 7 | 26 |
|
Age
[units: participants] |
|||||
| <=18 years | 6 | 9 | 4 | 7 | 26 |
| Between 18 and 65 years | 0 | 0 | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 | 0 | 0 |
|
Gender
[units: participants] |
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| Female | 2 | 3 | 1 | 1 | 7 |
| Male | 4 | 6 | 3 | 6 | 19 |
|
Attention Deficit Hyperactivity Disorder (ADHD) Subtype
[1] [units: participants] |
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| Combined Subtype | 4 | 6 | 3 | 7 | 20 |
| Other Subtype | 2 | 3 | 1 | 0 | 6 |
|
Conner's Global Impression-Parent Scale
[2] [units: scores on scale] Mean ± Standard Deviation |
13.7 ± 7.6 | 20.1 ± 6.8 | 25 ± 2.3 | 20.3 ± 6.7 | 19.78 ± 6.8 |
|
Attention Deficit Hyperactivity Disorder Rating Scale-IV Total Score
[3] [units: Score on scale] Mean ± Standard Deviation |
27 ± 11 | 37 ± 9.2 | 41 ± 10.2 | 33.7 ± 10.6 | 34.7 ± 11 |
|
Sleep Latency
[4] [units: minutes] Mean ± Standard Deviation |
22.5 ± 12.6 | 23.3 ± 21.8 | 54.5 ± 64.8 | 50.7 ± 12.4 | 37.8 ± 27.9 |
|
Total Sleep Time
[5] [units: hours] Mean ± Standard Deviation |
9.9 ± .9 | 9.5 ± .9 | 10.6 ± 1.2 | 9.6 ± 1.8 | 9.9 ± 1.8 |
|
Sleep Quality
[6] [units: Score] Mean ± Standard Deviation |
4.3 ± .8 | 4 ± 1 | 4 ± .8 | 3.1 ± .7 | 3.9 ± .8 |
| [1] | There are 3 subtypes of ADHD as defined by the DSM-IV-TR. Inattentive, Hyperactive/Impulsive and combined subtype (hyperactive/impulsive and inattentive). "Other subtype" refers to individuals who are not of the combined subtype but instead are either hyperactive/impulsive or inattentive type. |
|---|---|
| [2] | Rating scale filled out by the parents/caregivers. Scale consists of 28 questions divided into four subscales of oppositional problems, cognitive problems, hyperactivity and an ADHD index. Questions scored on a 4 point scale (0-3; 84 points possible), where a higher score indicates more severe symptom presentation. |
| [3] | An 18-item scale corresponding to the 18 items in the DSM-IV-TR that is divided into two subsclaes: hyperactivity/impulsivity and inattentiveness. Items scored on a 4-point frequency scale ranging from 0=never/rarely to 3=very often; 54 points possible with higher score indicating more severe symptoms. Rating scale is filled out by the caregiver. |
| [4] | Sleep latency was taken by patient diary which included questions for the caregiver and patient to answer together regarding sleep patterns (time to sleep, duration of sleep, night awakenings, sleep quality) |
| [5] | Total sleep time was taken by patient diary which included questions for the caregiver and patient to answer together regarding sleep patterns (time to sleep, duration of sleep, night awakenings, sleep quality) |
| [6] | Sleep quality was documented by patient diary which included questions for the caregiver and patient to answer together regarding sleep patterns (time to sleep, duration of sleep, night awakenings, sleep quality). Assessed on a 5 point scale (0-lowest quality; 5-highest quality) |
Outcome Measures
| 1. Primary: | Sleep Latency [ Time Frame: 9 weeks ] |
Hide Outcome Measure 1| Measure Type | Primary |
|---|---|
| Measure Title | Sleep Latency |
| Measure Description | Measure by daily subject sleep diary |
| Time Frame | 9 weeks |
| Safety Issue | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| 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 |
Reporting Groups
| Description | |
|---|---|
| 9 hr Wear | Result for all patients when patch worn for 9 hrs/day |
| 10 hr Wear | Result for all patients when patch worn for 10 hrs/day |
| 11 hr Wear | Result for all patients when patch worn for 11 hrs/day |
| 12 hr Wear | Result for all patients when patch worn for 12 hrs/day |
Measured Values
| 9 hr Wear | 10 hr Wear | 11 hr Wear | 12 hr Wear | |
|---|---|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
26 | 26 | 26 | 26 |
|
Sleep Latency
[units: minutes] Mean ( 95% Confidence Interval ) |
34
( 28 to 41 ) |
34
( 27 to 42 ) |
32
( 25 to 35 ) |
34
( 28 to 42 ) |
Statistical Analysis 1 for Sleep Latency
| Groups [1] | All groups |
|---|---|
| Method [2] | ANOVA |
| P Value [3] | 0.588 |
| Mean Difference (Final Values) [4] | 0.34 |
| Standard Deviation | ± 14 |
| 95% Confidence Interval | ( 0 to 233 ) |
| [1] | Additional details about the analysis, such as null hypothesis and power calculation: |
|---|---|
| No text entered. | |
| [2] | Other relevant information, such as adjustments or degrees of freedom: |
| No text entered. | |
| [3] | Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance: |
| No text entered. | |
| [4] | Other relevant estimation information: |
| No text entered. |
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
Publications of Results:
| Principal Investigators are NOT employed by the organization sponsoring the study. |
| There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. |
Limitations and Caveats
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| 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:
Name/Title: Arie Ashkenasi, MD
Organization: CoxHealth
phone: 011 972 50 3007477
e-mail: ashkenasi1@gmail.com
Organization: CoxHealth
phone: 011 972 50 3007477
e-mail: ashkenasi1@gmail.com
Publications of Results:
| Responsible Party: | Arie Ashkenasi, MD, Cox Health Systems |
| ClinicalTrials.gov Identifier: | NCT00989950 History of Changes |
| Other Study ID Numbers: | cox002, shire IND#54,732 |
| Study First Received: | September 30, 2009 |
| Results First Received: | March 12, 2012 |
| Last Updated: | July 16, 2012 |
| Health Authority: | United States: Food and Drug Administration |