Sleep & Pain in Juvenile Arthritis

NCT ID: NCT04133662

Last Updated: 2021-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-01
• Study Completion Date: 2021-03-05

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.

Conditions

Arthritis, Juvenile

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Group 1

Restricted sleep condition first, longer sleep condition second

Group Type: EXPERIMENTAL

Sleep Manipulation Protocol

Intervention Type: BEHAVIORAL

A structured sleep duration intervention will be taught to patients

Group 2

Longer sleep condition first, restricted sleep condition second

Group Type: EXPERIMENTAL

Sleep Manipulation Protocol

Intervention Type: BEHAVIORAL

A structured sleep duration intervention will be taught to patients

Interventions

Sleep Manipulation Protocol

A structured sleep duration intervention will be taught to patients

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role: collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

Brian Feldman

Division Head, Division of Rheumatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Hospital for Sick Children

Toronto, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 37914178 (View on PubMed)

Other Identifiers

1000061386

Identifier Type: -

Identifier Source: org_study_id