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

NCT ID: NCT03067025

Last Updated: 2019-11-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-03-07
• Study Completion Date: 2019-09-16

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

30 youth with MS

Actigraphy

Intervention Type: 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

Actigraphy

Intervention Type: 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).

Interventions

Actigraphy

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).

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: collaborator

Queen's University

OTHER

Sponsor Role: collaborator

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

E. Ann Yeh

Associate Scientist, Research Institute

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital for Sick Children

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

1000055719

Identifier Type: -

Identifier Source: org_study_id