Status:
COMPLETED
Melatonin for Sleep in MS
Lead Sponsor:
University of California, San Francisco
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
20-70 years
Phase:
NA
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. M...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 23 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 17 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04035889
Start Date
September 23 2019
End Date
November 17 2020
Last Update
January 19 2021
Active Locations (1)
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1
University of California, San Francisco
San Francisco, California, United States, 94158