Rheumatic DiseasesNCT07775612
Pain-Sleep in Rheumatic Disease
A study testing Better Nights, Better Days for Youth in people with Rheumatic Diseases and Arthritis, run by The Hospital for Sick Children.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 12 to 18 years, women only
- Conditions the study is for
- Rheumatic Diseases, Arthritis, Lupus
- What is being tested?
- Better Nights, Better Days for Youth
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 1 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Understanding the Pain-Sleep Relationship in Adolescents With Pediatric Rheumatic Disease Using 'Better Nights, Better Days for Youth': A Mixed-Methods Study
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.
Read the detailed description
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.
- Conditions
- Rheumatic Diseases, Arthritis, Lupus, Lupus Arthritis, Systemic Lupus Erythematosus, JIA, Dermatomyositis
- Being tested
- Better Nights, Better Days for Youth
- Keywords
- Sleep Disturbance, Sleep Problems, Insomnia, Cognitive behavioural therapies, CBT, Psychoeducation, Sleep Hygiene, Healthy Sleep Practices, Web-based, Digital, Better Nights, Better Days, Pediatric, Adolescents, Pain, Rheumatic Diseases, JIA, Juvenile Idiopathic Arthritis, SLE, Lupus, Vasculitis
- Medical subject headings
- Rheumatic Diseases, Arthritis, Lupus Erythematosus, Systemic, Dermatomyositis, Vasculitis, Arthritis, Juvenile, Parasomnias, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Better Nights, Better Days for YouthBehavioural
BNBD-Youth is a web-based sleep program, available only for research, designed to introduce healthy sleep practices to adolescents and young adults with sleep disturbances, aiming to improve their sleep quality and duration. It is entirely self-guided and adolescent-based (i.e., does not involve the caregiver or healthcare professional) and accessed on the individual's personal device (e.g., smartphone, tablet, computer). This program comprises 31 short, interactive microlessons organized into 4 overarching sessions.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Not described Receives: Behavioral: Better Nights, Better Days for Youth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index (ISI)
The Insomnia Severity Index (ISI) is a 7-item, validated self-report questionnaire that assesses the nature, severity, and impact of sleep over the past 2 weeks, with a total score ranging from 0-28. It has an acceptable internal consistency (Cronbach's α = 0.74) and is selected as Phase One's primary outcome because it is:
- Frequently used in sleep research with older children,
- Brief and easy to complete, and
- Sensitive to perceived sleep impact after treatment.
Measured: Baseline and immediately post-intervention (5 weeks post intervention-start)
Secondary outcomes (4)
PROMIS Pediatric Pain Interference - Short Form 8a
The PROMIS Pediatric Pain Interference - Short Form 8a is an 8-item self-report tool that assesses the impact of pain on function over the past seven days. It has high internal consistency in children, 8-18 years old, with chronic pain (Cronbach's α = 0.90). PROMIS instruments are scored using item-level calibrations and response pattern scoring. PROMIS scores will be calculated via REDCap auto-score, guided by the HealthMeasures Scoring.
Measured: Baseline and immediately post-intervention (5 weeks post intervention-start)
Pain Symptom Tracker
Daily pain will be collected via the "Check-in" feature on iCanCope, a smartphone-based pain self-management app developed through a phased, user-centred design study with adolescents with chronic pain and healthcare providers. Using numeric rating scales ranging from 0-10, the Check-in feature collects self-reported data on pain intensity, pain interference, mood, physical activity, sleep quality, and energy.
The Check-in feature uses adolescent-friendly language, pictorial response options, and daily push notifications at a time of their choice to promote engagement. In previous iCanCope studies with adolescents (12 to 18 years) with chronic pain and JIA, over half of the participants were shown to have high to moderate levels of adherence to the application.
Participants will be asked to complete three check-in entries each day. Each entry is estimated to take up to 1 minute to complete.
Measured: Baseline and immediately post-intervention (5 weeks post intervention-start)
Sleep Diary
In sleep research, sleep diaries are considered the "golden standard" for subjective sleep assessment. This study will use an investigator-developed sleep diary on REDCap that participants will complete upon waking to capture participants' sleep patterns close to the time they occur, including sleep efficiency (i.e., the percentage of total time spent asleep while in bed), a composite of total sleep time and total time in bed, and sleep quality. The necessary fields selected to calculate these sleep parameters were selected based on (1) this study's research objectives and (2) a previous research consensus-based panel.
Participants will be advised to complete 1 daily sleep diary entry shortly upon waking, reflecting the night before and the day of. Each diary entry is estimated to take up to 5 minutes to complete. Data entered by participants is automatically populated into REDCap.
Measured: Baseline and immediately post-intervention (5 weeks post intervention-start)
Actigraphy
Objective sleep-wake activity will be captured using an actigraph wrist device (ActiGraph GT9X Link [Ametris] and Actiwatch 2 [Philips Respironics]), which measures movement using a 3-axis accelerometer to detect raw position and rotational data. In sleep research, actigraphy is preferred to polysomnography, the "golden standard" for objective sleep measurement, due to practicality reported by research participants. In this study, actigraph data is compared with sleep diary data to screen for potential artifacts.
Measured: Baseline and immediately post-intervention (5 weeks post intervention-start)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Stinson, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07775612
- Sponsor's protocol ID
- 4161
- Status last verified
- Aug 2026
- First submitted
- 14 Aug 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Pain-Sleep Relationship in Adolescents With Pediatric Rheumatic Disease Using 'Better Nights, Better Days for Youth': A Mixed-Methods Study
- ClinicalTrials.gov ID
- NCT07775612
- Acronym / sponsor ID
- 4161
- Conditions
- Rheumatic Diseases, Arthritis, Lupus, Lupus Arthritis, Systemic Lupus Erythematosus, JIA, Dermatomyositis
- Keywords
- Sleep Disturbance, Sleep Problems, Insomnia, Cognitive behavioural therapies, CBT, Psychoeducation, Sleep Hygiene, Healthy Sleep Practices
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 20 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: Better Nights, Better Days for Youth |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Better Nights, Better Days for YouthBNBD-Youth is a web-based sleep program, available only for research, designed to introduce healthy sleep practices to adolescents and young adults with sleep disturbances, aiming to improve their sleep quality and duration. It is entirely self-guided and adolescent-based (i.e., does not involve the caregiver or healthcare professional) and accessed on the individual's personal device (e.g., smartphone, tablet, computer). This program comprises 31 short, interactive microlessons organized into 4 overarching sessions. | Behavioural | Intervention Arm |
Primary outcome
Insomnia Severity Index (ISI)
Time frame: Baseline and immediately post-intervention (5 weeks post intervention-start)
The Insomnia Severity Index (ISI) is a 7-item, validated self-report questionnaire that assesses the nature, severity, and impact of sleep over the past 2 weeks, with a total score ranging from 0-28. It has an acceptable internal consistency (Cronbach's α = 0.74) and is selected as Phase One's primary outcome because it is: 1. Frequently used in sleep research with older children, 2. Brief and easy to complete, and 3. Sensitive to perceived sleep impact after treatment.
4 secondary outcomes
PROMIS Pediatric Pain Interference - Short Form 8a
Time frame: Baseline and immediately post-intervention (5 weeks post intervention-start)
Pain Symptom Tracker
Time frame: Baseline and immediately post-intervention (5 weeks post intervention-start)
Sleep Diary
Time frame: Baseline and immediately post-intervention (5 weeks post intervention-start)
Actigraphy
Time frame: Baseline and immediately post-intervention (5 weeks post intervention-start)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Better Nights, Better Days for Youth in people with Rheumatic Diseases and Arthritis, run by The Hospital for Sick Children.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kelly Nguyen ((416) 813-1500, kelly.nguyen@sickkids.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity Index (ISI) (time frame: Baseline and immediately post-intervention (5 weeks post intervention-start)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.