Multiple Sclerosis
Conditions
Keywords
Sleep, Melatonin, Sleep disturbance
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.
Interventions
DIETARY_SUPPLEMENTMelatonin
Participants will start with 0.5 mg tablets of melatonin with the option of switching to an 'escalation dose' of 3 mg if no relief after 3 days.
DIETARY_SUPPLEMENTPlacebo
Placebo
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep time | 4 weeks | Total sleep time (time in bed spent sleeping after lights off) |
| Sleep quality | 4 weeks | Sleep quality and sleep disturbances assessed by the Pittsburgh Sleep Quality Index and Insomnia Severity Index |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep efficiency | 4 weeks | Sleep efficiency: % time asleep while in bed after lights off, averaged for mean nightly sleep efficiency Sleep onset latency time: time from lights off to sleep |
Countries
United States
Outcome results
None listed