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A Randomized, Crossover Pilot Trial of Melatonin for Sleep Disturbance in Adults With Multiple Sclerosis (MS)


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.


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)


  • University of California, San Francisco, San Francisco, California, United States, 94158
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