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J Spinal Cord Med. 2014 Jan;37(1):46-53. doi: 10.1179/2045772313Y.0000000099. Epub 2013 Oct 24.

Randomized controlled trial of pharmacological replacement of melatonin for sleep disruption in individuals with tetraplegia.

Abstract

OBJECTIVE:

To determine the effectiveness of a melatonin agonist for treating sleep disturbances in individuals with tetraplegia.

DESIGN:

Placebo-controlled, double-blind, crossover, randomized control trial.

SETTING:

At home.

PARTICIPANTS:

Eight individuals with tetraplegia, having an absence of endogenous melatonin production and the presence of a sleep disorder. Interventions Three weeks of 8 mg of ramelteon (melatonin agonist) and 3 weeks of placebo (crossover, randomized order) with 2 weeks of baseline prior to and 2 weeks of washout between active conditions.

OUTCOME:

Change in objective and subjective sleep.

MEASURES:

Wrist actigraphy, post-sleep questionnaire, Stanford sleepiness scale, SF-36.

RESULTS:

We observed no consistent changes in either subjective or objective measures of sleep, including subjective sleep latency (P = 0.55, Friedman test), number of awakenings (P = 0.17, Friedman test), subjective total sleep time (P = 0.45, Friedman test), subjective morning alertness (P = 0.35, Friedman test), objective wake after sleep onset (P = 0.70, Friedman test), or objective sleep efficiency (P = 0.78, Friedman test). There were significant increases in both objective total sleep time (P < 0.05, Friedman test), subjective time in bed (P < 0.05, Friedman test), and subjective sleep quality (P < 0.05, Friedman test), although these occurred in both arms. There were no significant changes in any of the nine SF-36 subscale scores (Friedman test, Ps >Bonferroni adjusted α of 0.005).

CONCLUSION:

In this pilot study, we were unable to show effectiveness of pharmacological replacement of melatonin for the treatment of self-reported sleep problems in individuals with tetraplegia. Trial Registration ClinicalTrials.gov # NCT00507546.

KEYWORDS:

Melatonin; Randomized control trial; Sleep; Sleep initiation and maintenance disorders; Spinal cord injuries; Tetraplegia

PMID:
24090266
PMCID:
PMC4066551
DOI:
10.1179/2045772313Y.0000000099
[Indexed for MEDLINE]
Free PMC Article
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