Clinical trial NCT04133662: Sleep & Pain in Juvenile Arthritis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthritis, Juvenile
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Children's Hospital Medical Center, Cincinnati
name: Canadian Institutes of Health Research (CIHR)
First posted: 2019-10-21
Enrollment: 31
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Pain as measured on the PROMIS Pain Interference Scale
timeFrame: baseline, end of baseline week, end of experimental week 1, end of experimental week 2
Secondary outcomes:
measure: Change in Pain as measured on the PROMIS Pain Behaviour Scale
timeFrame: baseline, end of baseline week, end of experimental week 1, end of experimental week 2
measure: Pain as measured using the iCanCope with Pain app
timeFrame: end of study (3 weeks)
measure: Change in Disease Activity
timeFrame: baseline, end of baseline week, end of experimental week 1, end of experimental week 2
measure: Change in Functional Status
timeFrame: baseline, end of baseline week, end of experimental week 1, end of experimental week 2
measure: Change in Health Related Quality of Life
timeFrame: baseline, end of baseline week, end of experimental week 1, end of experimental week 2
measure: Physical Activity
timeFrame: end of study (3 weeks)
measure: Change in Inattention and Sleepiness
timeFrame: baseline, end of baseline week, end of experimental week 1, end of experimental week 2
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
References: