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.
RCT Entities:
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.
Entities:
Keywords:
Melatonin; Randomized control trial; Sleep; Sleep initiation and maintenance disorders; Spinal cord injuries; Tetraplegia
Authors: D McGinty; H Gong; N Suntsova; Md N Alam; M Methippara; R Guzman-Marin; R Szymusiak Journal: Arch Ital Biol Date: 2004-07 Impact factor: 1.000
Authors: Sonia Ancoli-Israel; Roger Cole; Cathy Alessi; Mark Chambers; William Moorcroft; Charles P Pollak Journal: Sleep Date: 2003-05-01 Impact factor: 5.849