Arthritis, Juvenile
Conditions
Brief summary
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.
Interventions
BEHAVIORALSleep Manipulation Protocol
A structured sleep duration intervention will be taught to patients
Sponsors
Children's Hospital Medical Center, Cincinnati
Canadian Institutes of Health Research (CIHR)
The Hospital for Sick Children
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain as measured on the PROMIS Pain Interference Scale | baseline, end of baseline week, end of experimental week 1, end of experimental week 2 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain as measured using the iCanCope with Pain app | end of study (3 weeks) | Pain as measured using the iCanCope with Pain app |
| Change in Disease Activity | baseline, end of baseline week, end of experimental week 1, end of experimental week 2 | measured using the clinical Juvenile Arthritis Disease Activity Score (JADAS). Scored on a scale from 0-27, with 0 representing the best possible outcome |
| Change in Functional Status | baseline, end of baseline week, end of experimental week 1, end of experimental week 2 | measured using the Childhood Health Assessment Questionnaire (CHAQ). Scored on a scale of 0-3, with 0 representing the best possible outcome. |
| Change in Pain as measured on the PROMIS Pain Behaviour Scale | baseline, end of baseline week, end of experimental week 1, end of experimental week 2 | 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 |
| Physical Activity | end of study (3 weeks) | 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). |
| Change in Inattention and Sleepiness | baseline, end of baseline week, end of experimental week 1, end of experimental week 2 | 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) |
| Change in Health Related Quality of Life | baseline, end of baseline week, end of experimental week 1, end of experimental week 2 | 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. |
Countries
Canada
Outcome results
None listed