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| Name | Class |
|---|---|
| Children's Hospital Medical Center, Cincinnati | OTHER |
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Restricted sleep condition first, longer sleep condition second |
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| Group 2 | Experimental | Longer sleep condition first, restricted sleep condition second |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sleep Manipulation Protocol | Behavioral | A structured sleep duration intervention will be taught to patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain as measured on the PROMIS Pain Behaviour Scale | Change in Pain as measured on the PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Behaviour 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37914178 | Derived | 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. |
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| ID | Term |
|---|---|
| D001171 | Arthritis, Juvenile |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Pain as measured using the iCanCope with Pain app | Pain as measured using the iCanCope with Pain app | end of study (3 weeks) |
| Change in Disease Activity | measured using the clinical Juvenile Arthritis Disease Activity Score (JADAS). Scored on a scale from 0-27, with 0 representing the best possible outcome | baseline, end of baseline week, end of experimental week 1, end of experimental week 2 |
| Change in Functional Status | measured using the Childhood Health Assessment Questionnaire (CHAQ). Scored on a scale of 0-3, with 0 representing the best possible outcome. | baseline, end of baseline week, end of experimental week 1, end of experimental week 2 |
| Change in Health Related Quality of Life | measured using the Quality of My Life (QoML) questionnaire. This measure is comprised of 2 visual analog scales that measure overall quality of life and health related quality of life. Each scale ranges from 0-10 with 10 representing the best possible outcome. | baseline, end of baseline week, end of experimental week 1, end of experimental week 2 |
| Physical Activity | measured using a wrist-mounted accelerometer, we will measure the amount of time the subjects spend sedentary, mild, moderate to vigorous (MVPA), and vigorous (VPA) physical activity by looking at total metabolic equivalents (METs). | end of study (3 weeks) |
| Change in Inattention and Sleepiness | measured using the Inattention and Sleepiness Behaviour Rating Scale, scored on a scale of 0-39 with 0 representing the best possible score. Each sub-section can also be scored individually, with sleepiness being scored on a scale of 0-15 and inattention being scored on a scale of 0-27, with 0 representing the best possible score in both cases (i.e. the least sleepiness and least inattention) | baseline, end of baseline week, end of experimental week 1, end of experimental week 2 |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |