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Melatonin for Sleep in MS

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Melatonin
Placebo
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Sleep, Melatonin, Sleep disturbance

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • University of California, San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group 1

Group 2

Arm Description

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

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

Outcomes

Primary Outcome Measures

Sleep time
Total sleep time (time in bed spent sleeping after "lights off")
Sleep quality
Sleep quality and sleep disturbances assessed by the Pittsburgh Sleep Quality Index and Insomnia Severity Index

Secondary Outcome Measures

Sleep efficiency
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

Full Information

First Posted
July 25, 2019
Last Updated
January 14, 2021
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT04035889
Brief Title
Melatonin for Sleep in MS
Official Title
A Randomized, Crossover Pilot Trial of Melatonin for Sleep Disturbance in Adults With Multiple Sclerosis (MS)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
September 23, 2019 (Actual)
Primary Completion Date
November 17, 2020 (Actual)
Study Completion Date
November 17, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Sleep, Melatonin, Sleep disturbance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
Participants assigned to Group 1 will take 2 weeks of melatonin followed by 2 weeks of placebo
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Participants assigned to Group 2 will take 2 weeks of placebo followed by 2 weeks of melatonin.
Intervention Type
Dietary Supplement
Intervention Name(s)
Melatonin
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Sleep time
Description
Total sleep time (time in bed spent sleeping after "lights off")
Time Frame
4 weeks
Title
Sleep quality
Description
Sleep quality and sleep disturbances assessed by the Pittsburgh Sleep Quality Index and Insomnia Severity Index
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Sleep efficiency
Description
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
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Riley Bove, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Melatonin for Sleep in MS

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