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Sleep & Pain in Juvenile Arthritis

Not Applicable
Completed
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
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Group 2Sleep Manipulation ProtocolLonger sleep condition first, restricted sleep condition second
Group 1Sleep Manipulation ProtocolRestricted sleep condition first, longer sleep condition second
Primary Outcome Measures
NameTimeMethod
Change in Pain as measured on the PROMIS Pain Interference Scalebaseline, 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
NameTimeMethod
Change in Pain as measured on the PROMIS Pain Behaviour Scalebaseline, 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 Sleepinessbaseline, 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 append of study (3 weeks)

Pain as measured using the iCanCope with Pain app

Change in Disease Activitybaseline, 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 Lifebaseline, 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 Activityend 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 Statusbaseline, 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

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