NCT01434082

Brief Summary

The investigators are doing this study to look at sleep problems, daytime sleepiness, and thinking and behavior patterns in children with arthritis and in children without arthritis. Arthritis is a problem with joints. Some children have arthritis and some children do not have arthritis. Sleep disordered breathing is a sleeping problem in which some children snore and have pauses in their breathing during sleep. It is associated with not enough or fragmented sleep, poor school performance, problems paying attention, and behavior problems. The investigators do not know how many children with arthritis have sleep problems, and how it is linked to daytime sleepiness and children's learning, and behavior patterns compared to children without arthritis. The investigators need to study both children with arthritis and children without arthritis to learn more about these connections and to understand if they are the same or different in children with arthritis and in children without arthritis.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

September 9, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2011

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

September 14, 2011

Status Verified

September 1, 2011

Enrollment Period

3.3 years

First QC Date

September 9, 2011

Last Update Submit

September 12, 2011

Conditions

Keywords

sleepschool-age childrenChildren with and without arthritis

Outcome Measures

Primary Outcomes (1)

  • Prevalence of Sleep Disordered Breathing

    3.5 years

Secondary Outcomes (1)

  • Measures of Daytime Sleepiness

    3.5 years

Interventions

comparison of types of sleep disordered breathing (primary snoring, upper airway resistance syndrome, obstructive sleep apnea) in children with and without arthritis.

Eligibility Criteria

Age6 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

* Children with arthritis will be recruited from the Division of Pediatric Rheumatology at Seattle Children's Hospital. * Children without arthritis will be recruited from the King COunty community.

You may qualify if:

  • Children
  • Children with and without arthritis, 6 thru 11 years old, able to speak English
  • Children with JIA not recently hospitalized for severe JIA.
  • Parents
  • Subject's parents or legal guardian are \> 18 years of age and able to read and speak English.
  • Subject's parent or legal guardian has provided written informed consent prior to screening for this study.

You may not qualify if:

  • Children
  • A child with a history of/current diagnosis of a psychiatric condition meeting DSM-IV-TR (e.g. depression, bipolar disorder) that would interfere with ability to comply with protocol requirements, or give informed consent, or be expected to have disordered sleep.
  • A child with acute illness such as a cold or the flu that would interfere with sleep and neurobehavioral testing.
  • A chronic condition such as cancer, diabetes, or asthma which would, in the investigator's opinion, compromise the subject's ability to comply with the study requirements and interfere with ability to comply with protocol requirements.
  • Children admitted to the hospital for severe JIA within the last 2 months.
  • Children with a BMI \>95th percentile (defined as obesity by CDC) will be excluded because of potential impact of obesity on SDB.
  • Parents
  • A parent or legal guardian with a chronic condition that would compromise the parent's ability to comply with protocol requirements.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington School of Nursing

Seattle, Washington, 98195, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Morning urine and saliva

MeSH Terms

Conditions

Arthritis, Juvenile

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Teresa M Ward, PhD, RN

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Prinicpal Investigator

Study Record Dates

First Submitted

September 9, 2011

First Posted

September 14, 2011

Study Start

September 1, 2011

Primary Completion

January 1, 2015

Study Completion

February 1, 2015

Last Updated

September 14, 2011

Record last verified: 2011-09

Locations