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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.