Sleep, Physical Activity and Multiple Sclerosis Symptoms in Pediatric Multiple Sclerosis

Completed

• Conditions: Pediatric Multiple Sclerosis
• Interventions: Device: Actigraphy

• Registration Number: NCT03067025
• Lead Sponsor: The Hospital for Sick Children

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-01-03
• Study First Submitted QC: 2017-02-23
• Study First Posted: 2017-03-01
• Study Start: 2018-03-07
• Primary Completion: 2019-09-16
• Study Completion: 2019-09-16
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-19
• Last Update Posted: 2019-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Children ages 10 to 17 years, 11 months;
2. MS diagnosis following standard definitions (IPMSSG);
3. Healthy controls will include any child without a history of disease or disability

Exclusion Criteria

1. Inability to communicate or understand English;
2. Those within 30 days of a relapse;
3. Children who exhibit severe respiratory problems at baseline (e.g. use of tracheotomy)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
30 healthy control participants	Actigraphy	-
30 youth with MS	Actigraphy	-

Primary Outcome Measures

Name	Time	Method
Sleep quality, duration and timing	7 days	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.

Trial Locations

Locations (1)

Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada