A Randomized, Crossover Pilot Trial of Melatonin for Sleep Disturbance in Adults With Multiple Sclerosis (MS)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Sleep time
Study Overview
Brief Summary
Many people with MS report sleep disturbances. However, objective data on sleep quality in MS, such as those obtained using actigraphy, remain scant, as do data about optimal therapeutic management. Melatonin is frequently used to improve sleep parameters, both in healthy and neurological populations. Altered melatonin regulation and signaling has been implicated in MS, through observations including (1) MS risk associated with shift work, (2) contribution of melatonin to seasonal risk of MS relapses, and (3) possible reduction of endogenous melatonin levels from exogenous corticosteroid administration.
To the best of our knowledge, no studies have evaluated melatonin vs. placebo as a low-cost, low-risk agent to treat sleep disturbance in MS. To test this, we are conducting a randomized controlled pilot trial.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults aged 20-70 with a diagnosis of MS by 2010 McDonald Criteria or CIS (clinically isolated syndrome), who report sleep disturbance as measured by a score >=5 on the Pittsburgh Sleep Quality Index, or more specific insomnia symptoms (a score of >14 on the Insomnia Severity Index) over the past month.
- •Participants must be able to read and write English
Exclusion Criteria
- •Individuals with nocturnal asthma, use of melatonin or another sleep agent in the past 2 weeks, women attempting conception, relapse or steroids or infusible disease modifying therapies (DMTs) in prior month.
- •Non-English speaking individuals
- •Individuals with hypertension, impaired liver function, or seizure disorder
- •Individuals with untreated depression, as determined by a score greater than or equal to 8 points on the HADS (Hospital Anxiety and Depression Scale)
Arms & Interventions
Group 1
Participants assigned to Group 1 will take 2 weeks of melatonin followed by 2 weeks of placebo
Intervention: Placebo (Dietary Supplement)
Group 2
Participants assigned to Group 2 will take 2 weeks of placebo followed by 2 weeks of melatonin.
Intervention: Placebo (Dietary Supplement)
Group 2
Participants assigned to Group 2 will take 2 weeks of placebo followed by 2 weeks of melatonin.
Intervention: Melatonin (Dietary Supplement)
Group 1
Participants assigned to Group 1 will take 2 weeks of melatonin followed by 2 weeks of placebo
Intervention: Melatonin (Dietary Supplement)
Outcomes
Primary Outcomes
Sleep time
Time Frame: 4 weeks
Total sleep time (time in bed spent sleeping after "lights off")
Sleep quality
Time Frame: 4 weeks
Sleep quality and sleep disturbances assessed by the Pittsburgh Sleep Quality Index and Insomnia Severity Index
Secondary Outcomes
- Sleep efficiency(4 weeks)
Investigators
Riley Bove, MD
Assistant Professor of Neurology
University of California, San Francisco