ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03067025
Recruitment Status : Recruiting
First Posted : March 1, 2017
Last Update Posted : March 13, 2018
Sponsor:
Collaborators:
University of Alabama at Birmingham
Queen's University
Information provided by (Responsible Party):
E. Ann Yeh, 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.

Condition or disease Intervention/treatment
Pediatric Multiple Sclerosis Device: Actigraphy

Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Sleep, Physical Activity and Multiple Sclerosis Symptoms in Pediatric Multiple Sclerosis
Actual Study Start Date : March 7, 2018
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
30 youth with MS 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).

30 healthy control participants 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).




Primary Outcome Measures :
  1. Sleep quality, duration and timing [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03067025


Contacts
Contact: E. Ann Yeh, MD 416-813-7654 ext 207353 ann.yeh@sickkids.ca

Locations
Canada, Ontario
Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G1X8
Contact: Stephanie Grover, MSc    416-813-7654 ext 203796    stephanie.grover@sickkids.ca   
Contact: Samantha Stephens, PhD    416-813-7654 ext 328936    samantha.stephens@sickkids.ca   
Sponsors and Collaborators
The Hospital for Sick Children
University of Alabama at Birmingham
Queen's University

Responsible Party: E. Ann Yeh, Associate Scientist, Research Institute, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT03067025     History of Changes
Other Study ID Numbers: 1000055719
First Posted: March 1, 2017    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases