NCT03067025|Completed
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Sponsor study identifier
observational
50
1 country
1
Study Start
March 7, 2018
Actual (reported)Primary Completion
September 16, 2019
Actual (reported)Study Completion
September 16, 2019
Actual (reported)Most youth with MS experience symptoms such as depression and fatigue. In addition, cognitive issues, especially with attention and memory occur frequently. However, little is known about interventions that might work to improve these symptoms. In other work, the investigators have shown that higher levels of physical activity are associated with lower levels of depression and fatigue. Importantly, sleep problems are frequently encountered in youth with MS, and were seen in 60% of surveyed youth with MS in the investigators preliminary work. Modifiable lifestyle factors such as sleep and physical activity (PA) may play a key role in ameliorating common symptoms in pediatric MS. However, sleep has not been objectively described in pediatric MS, and the relationship between PA and sleep is poorly understood. This study aims to address these gaps.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 16, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 3, 2017
Actual (reported)March 1, 2017
Actual (reported)March 7, 2018
Actual (reported)September 16, 2019
Actual (reported)September 16, 2019
Actual (reported)Sleep quality, duration and timing
This will be determined by actigraphy, using the ActiwatchSpectrum Plus, worn on the non-dominant wrist 24 hours/day for seven days. Participants will also complete a sleep diary, the Children's Behavior Check List Sleep Composite, Children's Sleep Habits Questionnaire (CSHQ) and the Pediatric Sleep Questionnaire to derive contextual information about sleep and to identify sleep problems.
7 days
Actiwatch Spectrum Plus will be worn on the non-dominant wrist 24 hours/day for seven days. Actigraphy is a valid and reliable objective measure of sleep patterns, including sleep quality, duration, and timing when compared to polysomnography (PSG).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
There will be a total of 60 participants in this study. The study population consists of both patient participants (pediatric multiple sclerosis patients) and non-patient participants (healthy volunteers).
Hospital for Sick Children
Toronto, Ontario, M5G1X8, Canada
50 participants (actual enrollment reported by the registry).
First Submitted
January 3, 2017
First Posted
March 1, 2017
Study Start
March 7, 2018
Actual (reported)Mobile Attentional Bias Modification Training in Pediatric MS
Contact the study team to confirm eligibility.
Primary Completion
September 16, 2019
Actual (reported)Study Completion
September 16, 2019
Actual (reported)Last Updated
November 20, 2019
Record last verified: 2019-11
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Source: ClinicalTrials.gov.
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