Melatonin for Sleep in MS

NCT04035889 | Completed

• 1 other identifier: 19-27108
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Sleep; Melatonin; Sleep disturbance

Outcome Measures

Primary Outcomes (2)

• Sleep time

  Total sleep time (time in bed spent sleeping after "lights off")

  4 weeks

• Sleep quality

  Sleep quality and sleep disturbances assessed by the Pittsburgh Sleep Quality Index and Insomnia Severity Index

  4 weeks

Secondary Outcomes (1)

• Sleep efficiency

  4 weeks

Study Arms (2)

Group 1

EXPERIMENTAL

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

Dietary Supplement: Melatonin; Dietary Supplement: Placebo

Group 2

EXPERIMENTAL

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

Dietary Supplement: Melatonin; Dietary Supplement: Placebo

Interventions

Melatonin DIETARY_SUPPLEMENT

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.

Group 1; Group 2

Placebo DIETARY_SUPPLEMENT

Placebo

Group 1; Group 2

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94158, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis; Parasomnias

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Sleep Wake Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Riley Bove, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurology

Study Record Dates

• First Submitted: July 25, 2019
• First Posted: July 29, 2019
• Study Start: September 23, 2019
• Primary Completion: November 17, 2020
• Study Completion: November 17, 2020
• Last Updated: January 19, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)