Sleep Patterns in Children With and Without Juvenile Idiopathic Arthritis

NCT ID: NCT01434082

Last Updated: 2011-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-09-30

Study Completion Date

2015-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Juvenile Idiopathic Arthritis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Teresa Ward

Assistant Professor, Prinicpal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Washington School of Nursing

Seattle, Washington, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Teresa M Ward, PhD, RN

Role: CONTACT

206-221-6576

Audrey Hendrickson, MPH

Role: CONTACT

206-884-7495

Facility Contacts

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Teresa Ward, PhD, RN

Role: primary

206-221-6576

Audrey Hendrickson, MPH

Role: backup

206-884-7495

Other Identifiers

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1R01NR012734-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

JIA

Identifier Type: -

Identifier Source: org_study_id

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