title: Sleep disruption in tetraplegia: a randomised, double-blind, placebo-controlled crossover trial of 3 mg melatonin.
abstract: METHODS
  Randomised, double-blind, placebo-controlled crossover trial of melatonin supplementation to people with complete tetraplegia.
  
  
  OBJECTIVE
  To investigate the effect that 3 mg melatonin supplementation has on objective and subjective sleep, quality of life and mood of people living with complete tetraplegia.
  
  
  METHODS
  Austin Hospital Sleep Laboratory and participants' homes, Melbourne, Victoria, Australia.
  
  
  METHODS
  Two week run-in followed by 3 week nightly administration of 3 mg melatonin or placebo, 2-week washout and further 3 week administration of the opposite treatment. Four testing sessions were conducted; the last nights of the run-in, treatment and washout periods. Testing sessions involved recording full polysomnography, completing a questionnaire battery and collecting urine and blood samples. The questionnaires assessed mood, sleep symptoms and health-related quality of life, and the urine and plasma samples assayed 6-sulphatoxymelatonin (aMT6s) and melatonin levels, respectively. A sleep diary was completed throughout the study.
  
  
  RESULTS
  Eight participants (mean (s.d.): age 49.5 years (16), postinjury 16.9 years (7.1)) were recruited in which seven concluded the protocol. Endogenous-circulating melatonin was significantly higher (P < or = 0.01) following melatonin (urine: 152.94 μg h(-1) (74.51), plasma: 43,554.57 pM (33,527.11)) than placebo (urine: 0.86 μg h(-1) (0.40), plasma: 152.06 pM (190.55)). Subjective sleep improved significantly following melatonin specifically for duration of sleep per night and psychological wellbeing. Objective sleep showed a significant increase in light sleep with melatonin, with all other sleep parameters being unchanged.
  
  
  CONCLUSIONS
  These results suggest that increasing melatonin in people with complete tetraplegia is beneficial, especially for subjective sleep. Investigation of the pharmacokinetics of melatonin metabolism in this population is warranted.
  
  
  BACKGROUND
  This project is proudly supported by the Transport Accident Commission.
authors.affiliation: Institute for Breathing and Sleep, Austin Hospital, Melbourne, Victoria, Australia.
authors.forename: J
authors.initials: J
authors.lastname: Spong
authors.affiliation: 1] Institute for Breathing and Sleep, Austin Hospital, Melbourne, Victoria, Australia [2] Psychology Department, College of Arts, Victoria University, Melbourne, Victoria, Australia [3] The Bronowski Institute of Behavioural Neuroscience, Kyneton, Victoria, Australia.
authors.forename: G A
authors.initials: GA
authors.lastname: Kennedy
authors.affiliation: Department of Emergency Medicine, The Northern Hospital, Melbourne, Victoria, Australia.
authors.forename: J
authors.initials: J
authors.lastname: Tseng
authors.affiliation: Spinal Research Institute, Austin Health, Melbourne, Victoria, Australia.
authors.forename: D J
authors.initials: DJ
authors.lastname: Brown
authors.affiliation: 1] The Bronowski Institute of Behavioural Neuroscience, Kyneton, Victoria, Australia [2] Epworth Sleep Centre, Melbourne, Victoria, Australia.
authors.forename: S
authors.initials: S
authors.lastname: Armstrong
authors.affiliation: 1] Institute for Breathing and Sleep, Austin Hospital, Melbourne, Victoria, Australia [2] Spinal Research Institute, Austin Health, Melbourne, Victoria, Australia [3] Department of Medicine, Austin Health and Northern Health, University of Melbourne, Melbourne, Victoria, Australia.
authors.forename: D J
authors.identifier: 0000000325438722
authors.initials: DJ
authors.lastname: Berlowitz
mesh_terms: D000328:Adult; D000339:Affect / Q000187:drug effects; D000368:Aged; D000975:Antioxidants / Q000378:metabolism / Q000627:therapeutic use*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008550:Melatonin / Q000031:analogs & derivatives / Q000097:blood / Q000627:therapeutic use* / Q000652:urine; D008875:Middle Aged; D017286:Polysomnography; D011782:Quadriplegia / Q000150:complications* / Q000188:drug therapy / Q000523:psychology; D011788:Quality of Life; D012893:Sleep Wake Disorders / Q000097:blood / Q000188:drug therapy* / Q000209:etiology* / Q000652:urine; D011795:Surveys and Questionnaires
chemical_list: D000975:Antioxidants; C054513:6-sulfatoxymelatonin; D008550:Melatonin