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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Participants assigned to Group 1 will take 2 weeks of melatonin followed by 2 weeks of placebo |
|
| Group 2 | Experimental | Participants assigned to Group 2 will take 2 weeks of placebo followed by 2 weeks of melatonin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Riley Bove, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94158 | United States |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020447 | Parasomnias |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D008550 | Melatonin |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Placebo | Dietary Supplement | Placebo |
|
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D012893 | Sleep Wake Disorders |
| D001523 | Mental Disorders |
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |