Recruiting

Observational Study

Sponsor:

University of Washington

Code:

NCT01434082

Conditions

Juvenile Idiopathic Arthritis

Eligibility Criteria

Sex: All

Age: 6 - 11

Healthy Volunteers: Accepted

Interventions

comparison of types of sleep disordered breathing

Study Details

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.

Conditions

Juvenile Idiopathic Arthritis

Study ID

NCT01434082

Start date

Sep, 2011

Status verified date

Sep, 2011

Completion date

Feb, 2015

Anticipated

Primary completion date

Jan, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 11

Healthy Volunteers: Accepted

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Interventions

comparison of types of sleep disordered breathing

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

Primary outcome measure

  • Prevalence of Sleep Disordered Breathing [ Time Frame: 3.5 years ]

Central Contacts and Locations

Central contacts

Teresa M Ward, PhD, RN

206-221-6576teward@u.washington.edu

Audrey Hendrickson, MPH

206-884-7495audrey.hendrickson@seattlechildrens.org

Locations

University of Washington School of Nursing

Recruiting

Seattle, Washington, United States, 98195

Contacts

Teresa Ward, PhD, RN

206-221-6576teward@u.washington.edu

Audrey Hendrickson, MPH

206-884-7495audrey.hendrickson@seattlechildrens.org

Principal Investigator:

Teresa M Ward, PhD, RN

More Information

Sponsor

University of Washington

Last update posted

Sep 14, 2011

Last verified

Sep, 2011

Keywords

  • sleep
  • school-age children
  • Children with and without arthritis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Washington on 2011-09-14.