The effects of melatonin on sleep-wake rhythm of daytime haemodialysis patients: a randomized, placebo-controlled, cross-over study (EMSCAP study).
OBJECTIVE
The aim of this study was to investigate the effects of exogenous melatonin on sleep-wake rhythm in haemodialysis patients.


METHODS
The study design is a randomized, double-blind, placebo-controlled, cross-over study of 3 x 6 weeks melatonin 3 mg at 22.00 h every night. Haemodialysis patients were asked to fill out a sleep questionnaire and to wear an actometer to record their sleep problems objectively. Furthermore, melatonin concentrations in saliva were sampled the night after daytime haemodialysis and the consecutive night. Actometers, the sleep questionnaire and melatonin concentrations were repeated during the study.


RESULTS
In total, 20 patients (six female, median age 71 years) completed the investigation. On nights after daytime dialysis, objective sleep onset latency decreased significantly from a median of 44.5 (placebo) to a median of 15.5 min with melatonin (P < 0.01). Sleep efficiency increased from 67.3 to 73.1% with melatonin (P < 0.05). Actual sleep time increased from 376 min (placebo) to 388 min with melatonin (P < 0.01), and sleep fragmentation decreased from 4.5 to 3.1 (P < 0.01). Furthermore, subjective sleep parameters improved also. Patients reported less time needed to fall asleep (P < 0.05) and fewer wake periods (P < 0.05) on the nights with and without daytime dialysis and an increase in sleep time on the night of daytime dialysis (P < 0.05). Furthermore, the nocturnal melatonin rise was recovered.


CONCLUSIONS
Treatment with melatonin resulted in an improvement of subjective and objective sleep parameters, as well as a recovered nocturnal melatonin rhythm.
Koch
Birgit C P
BC
Department of Clinical Pharmacy, Meander MC, Amersfoot, The Netherlands. bcp.koch@meandermc.nl
Nagtegaal
J Elsbeth
JE
Hagen
E Chris
EC
van der Westerlaken
Monique M L
MM
Boringa
Jan B S
JB
Kerkhof
Gerard A
GA
Ter Wee
Piet M
PM
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002940:Circadian Rhythm / Q000187:drug effects*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007676:Kidney Failure, Chronic / Q000150:complications / Q000188:drug therapy; D008297:Male; D008550:Melatonin / Q000032:analysis / Q000494:pharmacology* / Q000627:therapeutic use; D008875:Middle Aged; D006435:Renal Dialysis; D012463:Saliva / Q000737:chemistry; D012890:Sleep / Q000187:drug effects*; D020178:Sleep Disorders, Circadian Rhythm / Q000188:drug therapy*; D011795:Surveys and Questionnaires
D008550:Melatonin