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Completed

NCT Number: NCT04133662

Sleep & Pain in Juvenile 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.

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Key information

Conditions

Arthritis, Juvenile Arthritis Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sleep Manipulation Protocol

Behavioral

A structured sleep duration intervention will be taught to patients

Primary outcomes

  1. Change in Pain as measured on the PROMIS Pain Interference Scale

    Time frame: 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 outcomes

  1. Change in Pain as measured on the PROMIS Pain Behaviour Scale

    Time frame: 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

  2. Pain as measured using the iCanCope with Pain app

    Time frame: end of study (3 weeks)

    Pain as measured using the iCanCope with Pain app

  3. Change in Disease Activity

    Time frame: 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

  4. Change in Functional Status

    Time frame: 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.

  5. Change in Health Related Quality of Life

    Time frame: 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.

  6. Physical Activity

    Time frame: 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).

  7. Change in Inattention and Sleepiness

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)
  • Children's Hospital Medical Center, Cincinnati

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Oct 21, 2019
Registry last updated
Apr 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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