Summary

for people ages 20-70 (full criteria)
at San Francisco, California
study started
estimated completion
Riley Bove, MD

Description

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.

Official Title

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

Keywords

Multiple Sclerosis Sleep Melatonin Sleep disturbance Sclerosis

Eligibility

You can join if…

Open to people ages 20-70

  • 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 CAN'T join 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)

Location

  • University of California, San Francisco accepting new patients
    San Francisco California 94158 United States

Lead Scientist

  • Riley Bove, MD
    Assistant Professor, Neurology. Authored (or co-authored) 74 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT04035889
Study Type
Interventional
Last Updated