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Sleep & Pain in Juvenile Arthritis

Primary Purpose

Arthritis, Juvenile

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Sleep Manipulation Protocol
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Arthritis, Juvenile

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Hospital for Sick Children

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group 1

Group 2

Arm Description

Restricted sleep condition first, longer sleep condition second

Longer sleep condition first, restricted sleep condition second

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Pain as measured using the iCanCope with Pain app
Pain as measured using the iCanCope with Pain app
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
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.
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.
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).
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)

Full Information

First Posted
October 8, 2019
Last Updated
April 23, 2021
Sponsor
The Hospital for Sick Children
Collaborators
Children's Hospital Medical Center, Cincinnati, Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT04133662
Brief Title
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

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
March 5, 2021 (Actual)
Study Completion Date
March 5, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children
Collaborators
Children's Hospital Medical Center, Cincinnati, Canadian Institutes of Health Research (CIHR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Juvenile

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
Restricted sleep condition first, longer sleep condition second
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Longer sleep condition first, restricted sleep condition second
Intervention Type
Behavioral
Intervention Name(s)
Sleep Manipulation Protocol
Intervention Description
A structured sleep duration intervention will be taught to patients
Primary Outcome Measure Information:
Title
Change in Pain as measured on the PROMIS Pain Interference Scale
Description
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
Time Frame
baseline, end of baseline week, end of experimental week 1, end of experimental week 2
Secondary Outcome Measure Information:
Title
Change in Pain as measured on the PROMIS Pain Behaviour Scale
Description
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
Time Frame
baseline, end of baseline week, end of experimental week 1, end of experimental week 2
Title
Pain as measured using the iCanCope with Pain app
Description
Pain as measured using the iCanCope with Pain app
Time Frame
end of study (3 weeks)
Title
Change in Disease Activity
Description
measured using the clinical Juvenile Arthritis Disease Activity Score (JADAS). Scored on a scale from 0-27, with 0 representing the best possible outcome
Time Frame
baseline, end of baseline week, end of experimental week 1, end of experimental week 2
Title
Change in Functional Status
Description
measured using the Childhood Health Assessment Questionnaire (CHAQ). Scored on a scale of 0-3, with 0 representing the best possible outcome.
Time Frame
baseline, end of baseline week, end of experimental week 1, end of experimental week 2
Title
Change in Health Related Quality of Life
Description
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.
Time Frame
baseline, end of baseline week, end of experimental week 1, end of experimental week 2
Title
Physical Activity
Description
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).
Time Frame
end of study (3 weeks)
Title
Change in Inattention and Sleepiness
Description
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)
Time Frame
baseline, end of baseline week, end of experimental week 1, end of experimental week 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Sleep & Pain in Juvenile Arthritis

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