Improving Sleep and Daytime Functioning Among Children Diagnosed With Attention Deficit Hyperactivity Disorder (ADHD)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Children's Hospital Medical Center, Cincinnati

ClinicalTrials.gov Identifier:

NCT00867451

First received: March 20, 2009

Last updated: March 15, 2012

Last verified: March 2012

History of Changes

Results First Received: September 28, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Attention Deficit Hyperactivity Disorder
Interventions:	Behavioral: Sleep Intervention Drug: Melatonin

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

Description

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.

Participant Flow: Overall Study

	Immediate Treatment	Delayed Treatment
STARTED	4	4
COMPLETED	4	4
NOT COMPLETED	0	0

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
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.
Total	Total of all reporting groups

Baseline Measures

	Immediate Treatment	Delayed Treatment	Total
Number of Participants [units: participants]	4	4	8
Age [units: participants]
<=18 years	4	4	8
Between 18 and 65 years	0	0	0
>=65 years	0	0	0
Age [units: years] Mean ± Standard Deviation	8.5 ± 1.3	9.5 ± 1.9	9.0 ± 1.6
Gender [units: participants]
Female	0	2	2
Male	4	2	6
Region of Enrollment [units: participants]
United States	4	4	8

Outcome Measures

Show All Outcome Measures

1. Primary:

Sleep Duration [ Time Frame: Baseline; Week 5 ]

Show Outcome Measure 1

2. Primary:

Sleep Activity (i.e., Average Amount of Time That the Participant Moved During Sleep) [ Time Frame: Baseline; Week 5 ]

Show Outcome Measure 2

3. Primary:

Length of Awake Time [ Time Frame: Baseline; Week 5 ]

Show Outcome Measure 3

4. Primary:

Percent Total Sleep [ Time Frame: Baseline, Week 5 ]

Show Outcome Measure 4

5. Primary:

Vanderbilt ADHD Rating Scales - Teacher (VADTRS): Inattention [ Time Frame: Baseline, Week 5 ]

Show Outcome Measure 5

6. Primary:

Vanderbilt ADHD Rating Scales - Parent (VADPRS): Inattention [ Time Frame: Baseline, Week 5 ]

Show Outcome Measure 6

7. Primary:

Vanderbilt ADHD Rating Scales - Teacher (VADTRS): Hyperactivity/Impulsivity [ Time Frame: Baseline, Week 5 ]

Show Outcome Measure 7

8. Primary:

Vanderbilt ADHD Rating Scales - Parent (VADPRS): Hyperactivity/Impulsivity [ Time Frame: Baseline, Week 35 ]

Show Outcome Measure 8

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

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
No text entered.

Results Point of Contact:

Name/Title: Richard Gilman, Ph.D.
Organization: Cincinnati Children's Hospital Medical Center
phone: 513-636-8172
e-mail: richard.gilman@cchmc.org

No publications provided

Responsible Party:	Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:	NCT00867451 History of Changes
Other Study ID Numbers:	CCHMC IRB# 2008-1287
Study First Received:	March 20, 2009
Results First Received:	September 28, 2011
Last Updated:	March 15, 2012
Health Authority:	United States: Food and Drug Administration

To Top