NCT04133662

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2018

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

October 8, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 21, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2021

Completed
Last Updated

April 27, 2021

Status Verified

April 1, 2021

Enrollment Period

2.9 years

First QC Date

October 8, 2019

Last Update Submit

April 23, 2021

Conditions

Arthritis, Juvenile

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Change in Pain as measured on the PROMIS Pain Behaviour Scale

    baseline, end of baseline week, end of experimental week 1, end of experimental week 2

  • Pain as measured using the iCanCope with Pain app

    end of study (3 weeks)

  • Change in Disease Activity

    baseline, end of baseline week, end of experimental week 1, end of experimental week 2

  • Change in Functional Status

    baseline, end of baseline week, end of experimental week 1, end of experimental week 2

  • Change in Health Related Quality of Life

    baseline, end of baseline week, end of experimental week 1, end of experimental week 2

  • +2 more secondary outcomes

Study Arms (2)

Group 1

EXPERIMENTAL

Restricted sleep condition first, longer sleep condition second

Behavioral: Sleep Manipulation Protocol

Group 2

EXPERIMENTAL

Longer sleep condition first, restricted sleep condition second

Behavioral: Sleep Manipulation Protocol

Interventions

Sleep Manipulation ProtocolBEHAVIORAL

A structured sleep duration intervention will be taught to patients

Group 1Group 2

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Publications (1)

  • Clairman H, Dover S, Tomlinson G, Beebe D, Cameron B, Laxer RM, Levy D, Narang I, Paetkau S, Schneider R, Spiegel L, Stephens S, Stinson J, Tse S, Weiss S, Whitney K, Feldman BM. Lengthening sleep reduces pain in childhood arthritis: a crossover randomised controlled trial. RMD Open. 2023 Oct;9(4):e003352. doi: 10.1136/rmdopen-2023-003352.

    PMID: 37914178DERIVED

MeSH Terms

Conditions

Arthritis, Juvenile

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Division Head, Division of Rheumatology

Study Record Dates

First Submitted

October 8, 2019

First Posted

October 21, 2019

Study Start

April 1, 2018

Primary Completion

March 5, 2021

Study Completion

March 5, 2021

Last Updated

April 27, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)