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NCT07775612Not yet recruiting

Pain-Sleep in Rheumatic Disease

Understanding the Pain-Sleep Relationship in Adolescents With Pediatric Rheumatic Disease Using 'Better Nights, Better Days for Youth': A Mixed-Methods Study

Source: ClinicalTrials.gov · Last updated 20 Aug 2026

Brief summary (registry, in English)

Overall, our understanding of how pain and sleep are experienced and how they can be treated in teenagers with rheumatic diseases is limited. This two-phased study aims to deepen our understanding of pain and sleep in this population using 'Better Nights, Better Days for Youth' (BNBD-Youth). 'BNBD-Youth' is a self-guided web-based sleep program for teenagers with sleep problems that uses educational and behavioural strategies, such as understanding sleep processes and changing unhelpful thoughts about sleep, to help improve sleep experiences. In Phase One, participants will use daily diaries to record their sleep and pain, and then use 'BNBDYouth' for five weeks to test whether it improves these outcomes. Then, in Phase Two, these participants will take part in an interview to further describe their experiences using 'BNBD-Youth' and their pain and sleep.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
43 (estimated)
First submitted
14 Aug 2026
Start date
1 Sept 2026
Primary completion date
1 Jan 2028
Lead sponsor
The Hospital for Sick Children
Diseases
Lupus (SLE)
NCT number
NCT07775612

What you commit to

  • Study type: Interventional
  • Planned participants: 43
  • From 1 Sept 2026 to the primary completion date, 1 Jan 2028
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Are currently receiving sleep-related psychosocial care, or

Other illness

  • Have a hearing, visual, or cognitive impairment that would prevent the completion of outcome measures, as indicated by the healthcare team,
  • Have a sleep disorder that requires medical or surgical intervention,

Other

  • Have used 'Better Nights, Better Days for Youth' before.

Who the study is looking for

  • Able to provide informed consent,
  • Can speak, read, and write in English,
  • Are an adolescent between the ages of 12 and 18 years,
  • Have a confirmed diagnosis of a chronic pediatric rheumatic disease,
  • Report at least a one-month history of dissatisfactory sleep quantity or quality with difficulty initiating sleep, difficulty maintaining sleep, or early-morning awakenings with an inability to return to sleep experienced at least three nights a week,
  • Report a minimum of mild pain (i.e., at least 1/10 pain on a numeric rating scale) at least once in the past week, and
  • Have access to the Internet and an email account.

Age in the registry: 12 years to 18 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.