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

Pediatric Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03067025
• Other study ID #: 1000055719
• Status: Completed
• Start date: March 7, 2018
• Est. completion date: September 16, 2019

Study information

• Verified date: November 2019
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 16, 2019
• Est. primary completion date: September 16, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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)

Related Conditions & MeSH terms

• Multiple Sclerosis
• Pediatric Multiple Sclerosis
• Sclerosis

Intervention

Device:
• 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).

Locations

Country	Name	City	State
Canada	Hospital for Sick Children	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
The Hospital for Sick Children	Queen's University, University of Alabama at Birmingham

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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