Sleep & Pain in Juvenile Arthritis

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

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.

Study Overview

• Status: Completed
• Conditions: Arthritis, Juvenile
• Intervention / Treatment: Behavioral: Sleep Manipulation Protocol

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X8
      • The Hospital for Sick Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group 1; Restricted sleep condition first, longer sleep condition second	Behavioral: Sleep Manipulation Protocol; A structured sleep duration intervention will be taught to patients
EXPERIMENTAL: Group 2; Longer sleep condition first, restricted sleep condition second	Behavioral: Sleep Manipulation Protocol; A structured sleep duration intervention will be taught to patients

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children
• Collaborators: Canadian Institutes of Health Research (CIHR); Children's Hospital Medical Center, Cincinnati

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2018
• Primary Completion (ACTUAL): March 5, 2021
• Study Completion (ACTUAL): March 5, 2021

Study Registration Dates

• First Submitted: October 8, 2019
• First Submitted That Met QC Criteria: October 17, 2019
• First Posted (ACTUAL): October 21, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 27, 2021
• Last Update Submitted That Met QC Criteria: April 23, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Juvenile
• Other Study ID Numbers: 1000061386

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No