Melatonin for Sleep in MS

Not Applicable

Completed

• Conditions: Multiple Sclerosis
• Interventions: Dietary Supplement: Melatonin; Dietary Supplement: Placebo

• Registration Number: NCT04035889
• Lead Sponsor: University of California, San Francisco

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-25
• Study First Submitted QC: 2019-07-26
• Study First Posted: 2019-07-29
• Study Start: 2019-09-23
• Primary Completion: 2020-11-17
• Study Completion: 2020-11-17
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-14
• Last Update Posted: 2021-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 1	Placebo	Participants assigned to Group 1 will take 2 weeks of melatonin followed by 2 weeks of placebo
Group 2	Melatonin	Participants assigned to Group 2 will take 2 weeks of placebo followed by 2 weeks of melatonin.
Group 2	Placebo	Participants assigned to Group 2 will take 2 weeks of placebo followed by 2 weeks of melatonin.
Group 1	Melatonin	Participants assigned to Group 1 will take 2 weeks of melatonin followed by 2 weeks of placebo

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States