Trial Outcomes & Findings for Improving Sleep and Daytime Functioning Among Children Diagnosed With Attention Deficit Hyperactivity Disorder (ADHD) (NCT NCT00867451)
NCT ID: NCT00867451
Last Updated: 2012-03-16
Results Overview
Data was gathered via actigraphy. Data was gathered on a nightly basis for one week at baseline and at week five. Data presented is the mean nightly value (in minutes) for that week.
COMPLETED
PHASE1/PHASE2
8 participants
Baseline; Week 5
2012-03-16
Participant Flow
Subjects were recruited from the community and families seeking services at the ADHD Clinic and in the Division of Developmental and Behavioral Pediatrics at Cincinnati Childrens Hospital Medical Center.
Participant milestones
| Measure |
Immediate Treatment
Children immediately received behavioral sleep interventions (following a structured pre-bedtime routine protocol, incorporating a white noise machine during sleep) for two weeks. If sleep parameters did improve (80% from baseline), melatonin (3mg, administered orally 1 hour prior to bedtime) supplemented the behavioral sleep treatments, for two weeks. None of the participants improved their sleep by 80% from baseline using the behavioral treatments. Thus, all participants progressed to the melatonin phase of the intervention.
|
Delayed Treatment
Pre-intervention data was collected for four weeks, after which children received behavioral sleep interventions (following a structured pre-bedtime routine protocol, incorporating a white noise machine during sleep) for two weeks. If sleep parameters did improve (80% from baseline), melatonin (3mg, administered orally 1 hour prior to bedtime) supplemented the behavioral sleep treatments, for two weeks. None of the participants improved their sleep by 80% from baseline using the behavioral treatments. Thus, all participants in the delayed treatment group progressed to the melatonin phase of the intervention.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
|
Overall Study
COMPLETED
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Improving Sleep and Daytime Functioning Among Children Diagnosed With Attention Deficit Hyperactivity Disorder (ADHD)
Baseline characteristics by cohort
| Measure |
Immediate Treatment
n=4 Participants
Children immediately received behavioral sleep interventions (following a structured pre-bedtime routine protocol, incorporating a white noise machine during sleep) for two weeks. If sleep parameters did improve (80% from baseline), melatonin (3mg, administered orally 1 hour prior to bedtime) supplemented the behavioral sleep treatments, for two weeks. None of the participants improved their sleep by 80% from baseline using the behavioral treatments. Thus, all participants progressed to the melatonin phase of the intervention.
|
Delayed Treatment
n=4 Participants
Pre-intervention data was collected for four weeks, after which children received behavioral sleep interventions (following a structured pre-bedtime routine protocol, incorporating a white noise machine during sleep) for two weeks. If sleep parameters did improve (80% from baseline), melatonin (3mg, administered orally 1 hour prior to bedtime) supplemented the behavioral sleep treatments, for two weeks. None of the participants improved their sleep by 80% from baseline using the behavioral treatments. Thus, all participants in the delayed treatment group progressed to the melatonin phase of the intervention.
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
8.5 years
STANDARD_DEVIATION 1.3 • n=5 Participants
|
9.5 years
STANDARD_DEVIATION 1.9 • n=7 Participants
|
9.0 years
STANDARD_DEVIATION 1.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline; Week 5Data was gathered via actigraphy. Data was gathered on a nightly basis for one week at baseline and at week five. Data presented is the mean nightly value (in minutes) for that week.
Outcome measures
| Measure |
Baseline
n=8 Participants
Results based on all participants (i.e., immediate and delayed-treatment participants).
|
Week 5
n=8 Participants
Results based on all participants (i.e., immediate and delayed-treatment participants).
|
|---|---|---|
|
Sleep Duration
|
609.57 minutes
Standard Deviation 25.54
|
602.79 minutes
Standard Deviation 25.92
|
PRIMARY outcome
Timeframe: Baseline; Week 5Data was gathered via actigraphy. Data was gathered on a nightly basis for one week at baseline and at week five. Data presented is the mean nightly value (in minutes) of movement during sleep, for that respective week.
Outcome measures
| Measure |
Baseline
n=8 Participants
Results based on all participants (i.e., immediate and delayed-treatment participants).
|
Week 5
n=8 Participants
Results based on all participants (i.e., immediate and delayed-treatment participants).
|
|---|---|---|
|
Sleep Activity (i.e., Average Amount of Time That the Participant Moved During Sleep)
|
31.25 minutes
Standard Deviation 19.00
|
24.89 minutes
Standard Deviation 11.72
|
PRIMARY outcome
Timeframe: Baseline; Week 5Data was gathered via actigraphy. Data was gathered on a nightly basis for one week at baseline and at week five. Data presented is the mean nightly value (in minutes) for that respective week.
Outcome measures
| Measure |
Baseline
n=8 Participants
Results based on all participants (i.e., immediate and delayed-treatment participants).
|
Week 5
n=8 Participants
Results based on all participants (i.e., immediate and delayed-treatment participants).
|
|---|---|---|
|
Length of Awake Time
|
36.52 minutes
Standard Deviation 20.20
|
19.81 minutes
Standard Deviation 17.59
|
PRIMARY outcome
Timeframe: Baseline, Week 5Data was gathered via actigraphy. Data on percentage of time individual was immobile during sleep was gathered on a nightly basis for one week at baseline and at week five. Data presented is the mean nightly percentage of immobility for that respective week.
Outcome measures
| Measure |
Baseline
n=8 Participants
Results based on all participants (i.e., immediate and delayed-treatment participants).
|
Week 5
n=8 Participants
Results based on all participants (i.e., immediate and delayed-treatment participants).
|
|---|---|---|
|
Percent Total Sleep
|
82.02 percentage of immobility
Standard Deviation 14.50
|
85.05 percentage of immobility
Standard Deviation 12.50
|
PRIMARY outcome
Timeframe: Baseline, Week 535-item measure to assess behaviors consistent with ADHD. Nine items reflected the Inattention scale. Range of scores for the Attention Problems domain was 0-27. Higher scores are indicative of higher levels of inattention.
Outcome measures
| Measure |
Baseline
n=8 Participants
Results based on all participants (i.e., immediate and delayed-treatment participants).
|
Week 5
n=8 Participants
Results based on all participants (i.e., immediate and delayed-treatment participants).
|
|---|---|---|
|
Vanderbilt ADHD Rating Scales - Teacher (VADTRS): Inattention
|
21.29 units on a scale
Standard Deviation 3.03
|
18.00 units on a scale
Standard Deviation 7.64
|
PRIMARY outcome
Timeframe: Baseline, Week 535-item measure to assess behaviors consistent with ADHD. Nine items reflected the Inattention scale. Range of scores for the Attention Problems domain was 0-27. Higher scores are indicative of higher levels of inattention.
Outcome measures
| Measure |
Baseline
n=8 Participants
Results based on all participants (i.e., immediate and delayed-treatment participants).
|
Week 5
n=8 Participants
Results based on all participants (i.e., immediate and delayed-treatment participants).
|
|---|---|---|
|
Vanderbilt ADHD Rating Scales - Parent (VADPRS): Inattention
|
21.29 units on a scale
Standard Deviation 3.03
|
13.42 units on a scale
Standard Deviation 6.45
|
PRIMARY outcome
Timeframe: Baseline, Week 535-item measure to assess behaviors consistent with ADHD. Nine items reflected the Inattention scale. Range of scores for the Hyperactivity/Impulsivity domain was 0-27. Higher scores are indicative of higher levels of hyperactive/impulsive behaviors.
Outcome measures
| Measure |
Baseline
n=8 Participants
Results based on all participants (i.e., immediate and delayed-treatment participants).
|
Week 5
n=8 Participants
Results based on all participants (i.e., immediate and delayed-treatment participants).
|
|---|---|---|
|
Vanderbilt ADHD Rating Scales - Teacher (VADTRS): Hyperactivity/Impulsivity
|
8.88 units on a scale
Standard Deviation 7.31
|
7.50 units on a scale
Standard Deviation 6.02
|
PRIMARY outcome
Timeframe: Baseline, Week 3535-item measure to assess behaviors consistent with ADHD. Nine items reflected the Inattention scale. Range of scores for the Hyperactivity/Impulsivity domain was 0-27. Higher scores are indicative of higher levels of hyperactive/impulsive behaviors.
Outcome measures
| Measure |
Baseline
n=8 Participants
Results based on all participants (i.e., immediate and delayed-treatment participants).
|
Week 5
n=8 Participants
Results based on all participants (i.e., immediate and delayed-treatment participants).
|
|---|---|---|
|
Vanderbilt ADHD Rating Scales - Parent (VADPRS): Hyperactivity/Impulsivity
|
15.29 units on a scale
Standard Deviation 6.89
|
13.42 units on a scale
Standard Deviation 6.42
|
Adverse Events
Immediate Treatment
Delayed Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Richard Gilman, Ph.D.
Cincinnati Children's Hospital Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place