Attention Disorder With Hyperactivity (ADHD)NCT00224731
Sleep Disorders in Children With ADHD
An observational study of Attention Disorder With Hyperactivity (ADHD), run by Hvolby, Allan, M.D. at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 10 years
- Conditions the study is for
- Attention Disorder With Hyperactivity (ADHD)
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2003to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 10 years
- All sexes
- Child
Who may be able to join
- We will compare a group of children with ADHD, other psychiatric disorder, and a healthy group of children age 5 - 10
Who cannot join
- mental retardation -
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Child psychiatric department and University of southern Denmark
Esbjerg, DK-6715
Allan Hvolby, M.D., +45 79182565, ahv@ribeamt.dk
Allan Hvolby, M.D
About this study
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).
Read more
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.
- Keywords
- Attention disorder with hyperactivity, sleep, stimulants, actigraphy
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2005 (estimated)
- Study startDec 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Disorder With Hyperactivity (ADHD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Other
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- Hvolby, Allan, M.D.
- Investigators
- allan hvolby, M.D, Principal investigator, child psychiatric department, Esbjerg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00224731
- Sponsor's protocol ID
- M-2549-03
- Status last verified
- Sep 2005
- First submitted
- 21 Sep 2005
- Last updated
- 26 Oct 2006
- Results posted
- No
Publications
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.
PubMed 18391140
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Disorders in Children With ADHD
- ClinicalTrials.gov ID
- NCT00224731
- Acronym / sponsor ID
- M-2549-03
- Keywords
- Attention disorder with hyperactivity, sleep, stimulants, actigraphy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants
- Lead sponsor
- Hvolby, Allan, M.D.
- Study start
- Dec 2003
- First posted
- 23 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Age groups
- Child
Key inclusion criteria (1 listed)
- We will compare a group of children with ADHD, other psychiatric disorder, and a healthy group of children age 5 - 10
Key exclusion criteria (1 listed)
- mental retardation -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2006.
- Derived from this study: PubMed 18391140Hvolby 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
allan hvolby, M.D principal investigator
child psychiatric department, Esbjerg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Attention Disorder With Hyperactivity (ADHD), run by Hvolby, Allan, M.D. at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact allan hvolby, M.D (+45 79182565, ahv@ribeamt.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00224731, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2006.