Melatonin for Sleep in MS

Completed · Not applicable · Has a placebo group

Conditions studied: Multiple Sclerosis

In brief

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.

Key facts

Study ID

NCT04035889

Run by

University of California, San Francisco

People needed

30

Starts

2019-09-23

Expected to finish

2020-11-17

Last updated by the study team

2021-01-19

Who can join

Age: 20 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

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

Full record on ClinicalTrials.gov

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