Sleep & Pain in Juvenile Arthritis

Study Overview
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Brief Summary
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Childhood arthritis is an important cause of pain for affected children and youth (adolescents). Many youth with arthritis also have trouble sleeping. They often struggle to sleep through the night, wake up earlier, and are sleepier during the day compared to healthy children. Our research group, among others, has shown a strong link between sleep and pain. The main purpose of this study is to assess the impact of changing sleeping patterns on pain, and disease activity, in teenagers with arthritis. We think that better sleep will directly lead to better health.

Official Title
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Sleep and Pain in Childhood Arthritis: A Crossover Randomized Trial Comparing Adequate and Restricted Sleep Duration, and Its Impact on Pain in Adolescents With Arthritis

Conditions
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Arthritis, Juvenile

Intervention / Treatment
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* Behavioral: Sleep Manipulation Protocol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patient in the rheumatology clinic at SickKids all subtypes of JIA, as per the ILAR criteria a baseline pain score of ≥ 1 on a visual analogue scale age from 12-18 years old capable of providing informed consent form themselves, as judged by the clinical team Exclusion Criteria: a known sleep disorder (e.g., obstructive sleep apnea, etc.) a high probability of having obstructive sleep apnea as determined by the Pediatric Sleep Questionnaire currently taking medication with the intent to impact sleep (e.g., zolpidem, benzodiazepines, etc.) taking corticosteroids (which may adversely affect sleep) obligations that require a bed time later than 10:00 pm or a wake time earlier than 5:30 am during the study period daily consumption of > 1 coffee or energy drink and/or > 3 caffeinated carbonated beverages do not speak/understand English with enough proficiency to complete all study related tasks, as judged by the clinical team

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Restricted sleep condition first, longer sleep condition second | Behavioral: Sleep Manipulation Protocol<br>* A structured sleep duration intervention will be taught to patients<br>|
| Experimental: Group 2<br>Longer sleep condition first, restricted sleep condition second | Behavioral: Sleep Manipulation Protocol<br>* A structured sleep duration intervention will be taught to patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain as measured on the PROMIS Pain Interference Scale | Change in Pain as measured on the PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Interference Scale. Scores can range from 0-100 with 100 representing the best possible outcome | baseline, end of baseline week, end of experimental week 1, end of experimental week 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain as measured on the PROMIS Pain Behaviour Scale | Change in Pain as measured on the PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Behaviour Scale. Scores can range from 0-100 with 100 representing the best possible outcome | baseline, end of baseline week, end of experimental week 1, end of experimental week 2 | 
| Pain as measured using the iCanCope with Pain app | Pain as measured using the iCanCope with Pain app | end of study (3 weeks) | 
| Change in Disease Activity | measured using the clinical Juvenile Arthritis Disease Activity Score (JADAS). Scored on a scale from 0-27, with 0 representing the best possible outcome | baseline, end of baseline week, end of experimental week 1, end of experimental week 2 | 
| Change in Functional Status | measured using the Childhood Health Assessment Questionnaire (CHAQ). Scored on a scale of 0-3, with 0 representing the best possible outcome. | baseline, end of baseline week, end of experimental week 1, end of experimental week 2 | 
| Change in Health Related Quality of Life | measured using the Quality of My Life (QoML) questionnaire. This measure is comprised of 2 visual analog scales that measure overall quality of life and health related quality of life. Each scale ranges from 0-10 with 10 representing the best possible outcome. | baseline, end of baseline week, end of experimental week 1, end of experimental week 2 | 
| Physical Activity | measured using a wrist-mounted accelerometer, we will measure the amount of time the subjects spend sedentary, mild, moderate to vigorous (MVPA), and vigorous (VPA) physical activity by looking at total metabolic equivalents (METs). | end of study (3 weeks) | 
| Change in Inattention and Sleepiness | measured using the Inattention and Sleepiness Behaviour Rating Scale, scored on a scale of 0-39 with 0 representing the best possible score. Each sub-section can also be scored individually, with sleepiness being scored on a scale of 0-15 and inattention being scored on a scale of 0-27, with 0 representing the best possible score in both cases (i.e. the least sleepiness and least inattention) | baseline, end of baseline week, end of experimental week 1, end of experimental week 2 |