Sleep Disorders in Children With ADHD | NCT00224731

Studies
Sleep Disorders in Children With ADHD

NCT00224731

Sponsor

Hvolby, Allan, M.D.

Status

Unknown status

Last Update Posted

Oct 26, 2006Estimated

Enrollment

100

Phase

Not provided

Conditions

Attention Disorder With Hyperactivity (ADHD)

Interventions

Not provided

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2005

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2003

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 21, 2005

First Submission Date that Met QC Criteria

Sep 21, 2005

First Posted Date

Sep 23, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 25, 2006

Last Update Posted Date

Oct 26, 2006Estimated

Description Module

Brief Summary

ADHD is often associated with sleep difficulties. Attention-deficit/hyperactivity disorder (ADHD) is the most common problem presented to children mental health services. The disorder affects approximately 5 % of school-age children. The core symptoms of this disorder include varying degrees of inattention, impulsiveness and restlessness.

In addition to the core symptoms, ADHD is associated with other problems (e.g. academic underachievement, poor social relations and sleep disturbances).

Despite clinical observations of sleep problems in children with ADHD, there is little empirical research on this topic. The prevalence, type of sleep problems, and significance of these sleep disturbances in children with ADHD remain undocumented.

The objective is to determine the relationship of sleep problems to attention deficit/hyperactive disorder, comorbid disorders, and the effect of stimulant treatment.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- We will compare a group of children with ADHD, other psychiatric disorder, and a healthy group of children age 5 - 10

Exclusion Criteria:

mental retardation -

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

10 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
allan hvolby, M.D	Contact	+45 79182565		ahv@ribeamt.dk

Overall Officials

Name	Affiliation	Role
allan hvolby, M.D	child psychiatric department, Esbjerg	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Child psychiatric department and University of southern Denmark	Recruiting	Esbjerg		DK-6715	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18391140	Derived	Hvolby A, Jorgensen J, Bilenberg N. Actigraphic and parental reports of sleep difficulties in children with attention-deficit/hyperactivity disorder. Arch Pediatr Adolesc Med. 2008 Apr;162(4):323-9. doi: 10.1001/archpedi.162.4.323.

ID	Term
D019958	Attention Deficit and Disruptive Behavior Disorders
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders