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

NCT03067025 | Completed

• 1 other identifier: 1000055719
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

30 youth with MS

Device: Actigraphy

30 healthy control participants

Device: Actigraphy

Interventions

Actigraphy DEVICE

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).

30 healthy control participants; 30 youth with MS

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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).

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• University of Alabama at Birmingham: collaborator
• Queen's University: collaborator

Study Sites (1)

Hospital for Sick Children

Toronto, Ontario, M5G1X8, Canada

Location

MeSH Terms

Interventions

Actigraphy

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis; Accelerometry; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Scientist, Research Institute

Study Record Dates

• First Submitted: January 3, 2017
• First Posted: March 1, 2017
• Study Start: March 7, 2018
• Primary Completion: September 16, 2019
• Study Completion: September 16, 2019
• Last Updated: November 20, 2019

Record last verified: 2019-11

Locations

CA (1)