Arthritis, JuvenileNCT04133662
Sleep & Pain in Juvenile Arthritis
A study testing Sleep Manipulation Protocol in people with Arthritis, Juvenile, run by The Hospital for Sick Children at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Arthritis, Juvenile
- What is being tested?
- Sleep Manipulation Protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2018to 5 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sleep and Pain in Childhood Arthritis: A Crossover Randomized Trial Comparing Adequate and Restricted Sleep Duration, and Its Impact on Pain in Adolescents With Arthritis
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
- Being tested
- Sleep Manipulation Protocol
- Medical subject headings
- Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep Manipulation ProtocolBehavioural
A structured sleep duration intervention will be taught to patients
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Restricted sleep condition first, longer sleep condition second Receives: Behavioral: Sleep Manipulation Protocol |
| Group 2 | Experimental | Longer sleep condition first, restricted sleep condition second Receives: Behavioral: Sleep Manipulation Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline, end of baseline week, end of experimental week 1, end of experimental week 2
Secondary outcomes (7)
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
Measured: baseline, end of baseline week, end of experimental week 1, end of experimental week 2
Pain as measured using the iCanCope with Pain app
Pain as measured using the iCanCope with Pain app
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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)
Measured: baseline, end of baseline week, end of experimental week 1, end of experimental week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2019
- Study start1 Apr 2018
- Primary completion5 Mar 2021
- Study completion5 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arthritis, JuvenileStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital Medical Center, Cincinnati, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Brian Feldman, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04133662
- Sponsor's protocol ID
- 1000061386
- Status last verified
- Apr 2021
- First submitted
- 8 Oct 2019
- Last updated
- 27 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37914178
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep and Pain in Childhood Arthritis: A Crossover Randomized Trial Comparing Adequate and Restricted Sleep Duration, and Its Impact on Pain in Adolescents With Arthritis
- ClinicalTrials.gov ID
- NCT04133662
- Acronym / sponsor ID
- 1000061386
- Conditions
- Arthritis, Juvenile
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Children's Hospital Medical Center, Cincinnati, Canadian Institutes of Health Research (CIHR)
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 5 Mar 2021 (actual)
- Study completion
- 5 Mar 2021 (actual)
- First posted
- 21 Oct 2019 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Behavioral: Sleep Manipulation ProtocolRestricted sleep condition first, longer sleep condition second |
| Group 2 | Experimental | Behavioral: Sleep Manipulation ProtocolLonger sleep condition first, restricted sleep condition second |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Sleep Manipulation ProtocolA structured sleep duration intervention will be taught to patients | Behavioural | Group 1, Group 2 |
Primary outcome
Change in Pain as measured on the PROMIS Pain Interference Scale
Time frame: baseline, end of baseline week, end of experimental week 1, end of experimental week 2
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
7 secondary outcomes
Change in Pain as measured on the PROMIS Pain Behaviour Scale
Time frame: baseline, end of baseline week, end of experimental week 1, end of experimental week 2
Pain as measured using the iCanCope with Pain app
Time frame: end of study (3 weeks)
Change in Disease Activity
Time frame: baseline, end of baseline week, end of experimental week 1, end of experimental week 2
Change in Functional Status
Time frame: baseline, end of baseline week, end of experimental week 1, end of experimental week 2
Change in Health Related Quality of Life
Time frame: baseline, end of baseline week, end of experimental week 1, end of experimental week 2
Physical Activity
Time frame: end of study (3 weeks)
Change in Inattention and Sleepiness
Time frame: baseline, end of baseline week, end of experimental week 1, end of experimental week 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
- Derived from this study: PubMed 37914178Clairman 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.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Manipulation Protocol in people with Arthritis, Juvenile, run by The Hospital for Sick Children at 1 site in Canada.
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 5 inclusion and 7 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: finished, as of the sponsor's last update on 27 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain as measured on the PROMIS Pain Interference Scale (time frame: baseline, end of baseline week, end of experimental week 1, end of experimental week 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04133662, which also lists 1 linked publication.
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 27 Apr 2021.