Juvenile Idiopathic ArthritisJIANCT01434082
Sleep Patterns in Children With and Without Juvenile Idiopathic Arthritis
An observational study of Juvenile Idiopathic Arthritis, run by University of Washington at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Juvenile Idiopathic Arthritis
- What is being tested?
- comparison of types of sleep disordered breathing
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Feb 2015
- 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 6 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Washington School of Nursing
Seattle, Washington, 98195
Teresa Ward, PhD, RN, 206-221-6576, teward@u.washington.edu
Audrey Hendrickson, MPH, 206-884-7495, audrey.hendrickson@seattlechildrens.org
About this study
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.
Read the 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:
- 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.
- 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:
- 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
- Juvenile Idiopathic Arthritis
- Being tested
- comparison of types of sleep disordered breathing
- Keywords
- sleep, school-age children, Children with and without arthritis
- Medical subject headings
- Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
comparison of types of sleep disordered breathingBehavioural
comparison of types of sleep disordered breathing (primary snoring, upper airway resistance syndrome, obstructive sleep apnea) in children with and without arthritis.
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Sleep Disordered Breathing
Measured: 3.5 years
Secondary outcomes (1)
Measures of Daytime Sleepiness
After the overnight sleep study, children will undergo multiple sleep latency tests which are four 20-minute nap opportunities that assess daytime sleepiness.
Measured: 3.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionJan 2015 (estimated)
- Study completionFeb 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Juvenile Idiopathic ArthritisStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Teresa Ward, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01434082
- Sponsor's protocol ID
- JIA
- Other IDs
- 1R01NR012734-01
- Acronym
- JIA
- Status last verified
- Sep 2011
- First submitted
- 9 Sep 2011
- Last updated
- 14 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Patterns in Children With and Without Juvenile Idiopathic Arthritis
- ClinicalTrials.gov ID
- NCT01434082
- Acronym / sponsor ID
- JIA / JIA
- Conditions
- Juvenile Idiopathic Arthritis
- Keywords
- sleep, school-age children, Children with and without arthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Feb 2015 (estimated)
- First posted
- 14 Sep 2011 (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.
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
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:
- 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.
- 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:
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| comparison of types of sleep disordered breathingcomparison of types of sleep disordered breathing (primary snoring, upper airway resistance syndrome, obstructive sleep apnea) in children with and without arthritis. | Behavioural | – |
Primary outcome
Prevalence of Sleep Disordered Breathing
Time frame: 3.5 years
1 secondary outcome
Measures of Daytime Sleepiness
Time frame: 3.5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2011.
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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.
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 Juvenile Idiopathic Arthritis, run by University of Washington at 1 site in United States.
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 6 inclusion and 8 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 14 Sep 2011. 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 United States. 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 Teresa M Ward, PhD, RN (206-221-6576, teward@u.washington.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Sleep Disordered Breathing (time frame: 3.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Sep 2011.