Who may be eligible for the Pain-Sleep in Rheumatic Disease trial?

Inclusion Criteria: 1. Able to provide informed consent, 2. Can speak, read, and write in English, 3. Are an adolescent between the ages of 12 and 18 years, 4. Have a confirmed diagnosis of a chronic pediatric rheumatic disease, 5. 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, 6. 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 7. Have access to the Internet and an email account. Exclusion Criteria: 1. Have a hearing, visual, or cognitive impairment that would prevent the completion of outcome measures, as indicated by the healthcare team, 2. Have a sleep disorder that requires medical or surgical intervention, 3. Are currently receiving sleep-related psychosocial care, or 4. Have used 'Better Nights, Better Days for Youth' before.

ClinicalTrials.gov record NCT07775612

Pain-Sleep in Rheumatic Disease

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

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

About this page. This page shows the study's official ClinicalTrials.gov record ↗, with added help to make it easier to understand. We explain medical terms, highlight key details in plain language, and suggest questions you may want to ask the study team.

The record is periodically copied from ClinicalTrials.gov and may lag behind changes. AI summaries are checked by software, not a clinician.Read moreShow less

The official record is written by the study sponsor and published on ClinicalTrials.gov. It may not always reflect the latest changes. Before making any decisions, please confirm important information with the study team and your own healthcare team.

Where you see "AI summary", AI was used to create a plain-language explanation and software checked it against the source. It has not been reviewed by a clinician, so it may contain mistakes or leave out important details.

StatusNot yet recruitingThe study has been registered but has not started enrolling. Sites and contacts may not be listed yet.

Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.

Age12 years old to 18 years old

SexFemale

AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This two-phase study gives adolescents with pediatric rheumatic disease access to a self-guided web sleep program (BNBD-Youth) and measures sleep and pain before and after use. Phase One is a single-group trial using daily diaries, actigraphy, app-based check-ins, and questionnaires. Phase Two involves interviews with a subset of participants to describe their experiences using the program and living with pain and sleep problems.

What it is studying. The study tests the use of BNBD-Youth (a self-guided web sleep program) to characterize the relationship between pain and sleep in adolescents with pediatric rheumatic disease and to estimate the program's preliminary effects on sleep and pain outcomes. It then explores participants' personal experiences with sleep, pain, and the program through interviews.

What the researchers hope to learn. To describe how pain and sleep are related in adolescents with pediatric rheumatic disease; to gather preliminary data on BNBD-Youth's effects on sleep and pain outcomes; and to use interview data to better understand participants' sleep and pain experiences.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Behavioral: Better Nights, Better Days for Youth

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

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.

Exclusion criteria

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,
Are currently receiving sleep-related psychosocial care, or
Have used 'Better Nights, Better Days for Youth' before.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

Across two phases, this research will use an explanatory sequential mixed methods design involving (1) a single-arm trial of Better Nights, Better Days for Youth (BNBD-Youth) with 30 adolescents, aged 12-18, with a chronic pediatric rheumatic disease to characterize the correlational pain-sleep relationship and to estimate the preliminary effectiveness of the web-based sleep program on sleep and pain outcomes. These quantitative findings will guide the selection of participants, and the interview questions asked in the (2) subsequent qualitative study involving individual, semi-structured interviews with 10-26 quantitative participants to further contextualize the pain-sleep relationship using the personal pain and sleep experiences reported by participants. The quantitative and qualitative datasets will be analyzed separately and then merged during the interpretation phase.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants complete online questionnaires at the start (baseline) and immediately after a 5‑week program. They will use the BNBD‑Youth self-guided web program on their personal device, complete one daily sleep diary entry (about 5 minutes each morning), and make three brief daily check-ins in the iCanCope app (about 1 minute each). At baseline and again after the 5‑week program participants will wear an actigraph wrist device to record sleep‑wake activity. A subset of participants (about 10–26) will take part in a one-on-one, semi-structured interview about their pain and sleep experiences.

How the study is structured. Interventional, single-group study with no masking. About 30 adolescents will complete baseline measures, use the BNBD-Youth web program for five weeks, and repeat the same measures immediately after the five-week period. During the quantitative phase participants complete daily sleep diaries, three short daily app "check-ins" for pain, wear an actigraphy wrist device to record sleep-wake activity, and complete questionnaires including the Insomnia Severity Index and PROMIS pain interference. A subset of 10–26 participants from the quantitative phase will take part in individual semi-structured interviews to add personal context to the quantitative findings.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

The registry says recruitment has not started. When is it expected to open, and can I register interest now?
No sites are listed on the registry yet. Where will the study take place?
Which of the eligibility criteria would need to be checked with tests before I could join?

More on polymyositis

This trial is also listed on this website under dermatomyositis.

Clinical trials55 trials listed for polymyositisEvery trial the registry lists for polymyositis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in polymyositis researchLatest monthly update: September 2026. Includes: CD4 count risk. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start: Sep 1, 2026 (estimated)
Primary completion: Jan 1, 2028 (estimated)
Study completion: Jan 1, 2028 (estimated)
Target enrollment: 43 participants (estimated)
Last updated on registry: Aug 20, 2026
Data verified: Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor: The Hospital for Sick Children
Principal investigator: Jennifer Stinson, Senior Scientist, Child Health Evaluative Sciences
The Hospital for Sick Children

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Kelly Nguyen 📞 (416) 813-1500 ✉ kelly.nguyen@sickkids.ca

Participating sites

Study locations have not been posted on ClinicalTrials.gov yet. This study is not yet recruiting, so sites may be added when recruitment begins. The central study contact above may be able to tell you about planned sites.

Terms used on this page · explanations by MedicalUpdates.ai

informed consent: The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
outcome measures: Something the study measures to judge its results, such as a symptom score, a blood test or survival. Outcomes are grouped as primary, secondary and sometimes exploratory.
Inclusion Criteria: The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria: The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
single-arm: All participants receive the same treatment or follow the same plan. There is no comparison group within the study.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this website; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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