Sleep & Pain in Juvenile Arthritis
- Conditions
- Arthritis, Juvenile
- Interventions
- Behavioral: Sleep Manipulation Protocol
- Registration Number
- NCT04133662
- Lead Sponsor
- The Hospital for Sick Children
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 31
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Group 2 Sleep Manipulation Protocol Longer sleep condition first, restricted sleep condition second Group 1 Sleep Manipulation Protocol Restricted sleep condition first, longer sleep condition second
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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)
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 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.
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 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.
Trial Locations
- Locations (1)
The Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada