Sleep Patterns in Children With and Without Juvenile Idiopathic Arthritis (JIA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2011 by University of Washington
Sponsor:
Information provided by (Responsible Party):
Teresa Ward, University of Washington
ClinicalTrials.gov Identifier:
NCT01434082
First received: September 9, 2011
Last updated: September 12, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention
Juvenile Idiopathic Arthritis
Behavioral: comparison of types of sleep disordered breathing

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Sleep Patterns in Children With and Without Juvenile Idiopathic Arthritis

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Prevalence of Sleep Disordered Breathing [ Time Frame: 3.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measures of Daytime Sleepiness [ Time Frame: 3.5 years ] [ Designated as safety issue: No ]
    After the overnight sleep study, children will undergo multiple sleep latency tests which are four 20-minute nap opportunities that assess daytime sleepiness.


Biospecimen Retention:   Samples With DNA

Morning urine and saliva


Estimated Enrollment: 150
Study Start Date: September 2011
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: 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.
Detailed Description:

Overview of Study:

  • Children and their parent will be scheduled to come to the University of Washington School of Nursing Sleep Laboratory for overnight polysomnography, and to complete multi-sleep latency tests and a battery of neurobehavioral performance tests the next day at a convenient time and day.
  • Children will be asked to complete a sleep, symptoms (pain, fatigue), behavior, and day to day activity surveys, and the parent who accompanies the child to the laboratory, will be asked to complete surveys assessing demographics, child's usual sleep, behavior, school performance, health status, and family functioning.
  • Children will also be asked to spit in a container and urinate in a container upon awakening in the morning after their sleep study.

Primary Aims of the Study:

  1. Compare indices of sleep disturbances, risk factors, and type of sleep disordered breathing(primary snoring, upper airway resistance syndrome, obstructive sleep apnea) in Juvenile Idiopathic Arthritis (JIA) to age, sex matched control children.
  2. Compare scores on neurobehavioral tests and daytime sleepiness; and to describe associations between indices of sleep disturbances on neurobehavioral performance and daytime sleepiness in JIA to age, sex matched control children.

Secondary Objectives:

1. Describe and compare parent report of child's sleep habits, fatigue, behavior, school performance, day-to-day activity, and family functioning in children with JIA to age, sex matched control children.

  Eligibility

Ages Eligible for Study:   6 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-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.
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01434082

Contacts
Contact: Teresa M Ward, PhD, RN 206-221-6576 teward@u.washington.edu
Contact: Audrey Hendrickson, MPH 206-884-7495 audrey.hendrickson@seattlechildrens.org

Locations
United States, Washington
University of Washington School of Nursing Recruiting
Seattle, Washington, United States, 98195
Contact: Teresa Ward, PhD, RN    206-221-6576    teward@u.washington.edu   
Contact: Audrey Hendrickson, MPH    206-884-7495    audrey.hendrickson@seattlechildrens.org   
Principal Investigator: Teresa M Ward, PhD, RN         
Sponsors and Collaborators
University of Washington
  More Information

No publications provided

Responsible Party: Teresa Ward, Assistant Professor, Prinicpal Investigator, University of Washington
ClinicalTrials.gov Identifier: NCT01434082     History of Changes
Other Study ID Numbers: JIA, 1R01NR012734-01
Study First Received: September 9, 2011
Last Updated: September 12, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
sleep
school-age children
Children with and without arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on August 26, 2014