Melatonin for Sleep in MS

University of California San Francisco (UCSF)

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Melatonin

Study type: Interventional

Funder types: Other

Identifiers

NCT04035889

19-27108

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups

Group 1

Experimental group

Description:

Participants assigned to Group 1 will take 2 weeks of melatonin followed by 2 weeks of placebo

Treatment:

Dietary Supplement: Melatonin

Dietary Supplement: Placebo

Group 2

Experimental group

Description:

Participants assigned to Group 2 will take 2 weeks of placebo followed by 2 weeks of melatonin.

Treatment:

Dietary Supplement: Melatonin

Dietary Supplement: Placebo