Sleep disruption in tetraplegia: a randomised, double-blind, placebo-controlled crossover trial of 3 mg melatonin

Study design: Randomised, double-blind, placebo-controlled crossover trial of melatonin supplementation to people with complete tetraplegia. Objectives: To investigate the effect that 3 mg melatonin supplementation has on objective and subjective sleep, quality of life and mood of people living with...

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Veröffentlicht in:Spinal cord 2014-08, Vol.52 (8), p.629-634
Hauptverfasser: Spong, J, Kennedy, G A, Tseng, J, Brown, D J, Armstrong, S, Berlowitz, D J
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container_end_page 634
container_issue 8
container_start_page 629
container_title Spinal cord
container_volume 52
creator Spong, J
Kennedy, G A
Tseng, J
Brown, D J
Armstrong, S
Berlowitz, D J
description Study design: Randomised, double-blind, placebo-controlled crossover trial of melatonin supplementation to people with complete tetraplegia. Objectives: 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. Setting: 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 ⩽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. Conclusion: 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. Sponsorship: This project is proudly supported by the Transport Accident Commission.
doi_str_mv 10.1038/sc.2014.84
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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 ⩽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. Conclusion: 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. 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Objectives: 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. Setting: 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 ⩽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. Conclusion: 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. Sponsorship: This project is proudly supported by the Transport Accident Commission.</abstract><cop>London</cop><pub>Nature Publishing Group UK</pub><pmid>24891007</pmid><doi>10.1038/sc.2014.84</doi><tpages>6</tpages><orcidid>https://orcid.org/0000-0003-2543-8722</orcidid><orcidid>https://orcid.org/0000000325438722</orcidid><oa>free_for_read</oa></addata></record>
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source MEDLINE; EZB-FREE-00999 freely available EZB journals
subjects 692/308/409
Adult
Affect - drug effects
Aged
Anatomy
Antioxidants - metabolism
Antioxidants - therapeutic use
Biomedical and Life Sciences
Biomedicine
Cross-Over Studies
Double-Blind Method
Female
Human Physiology
Humans
Male
Melatonin - analogs & derivatives
Melatonin - blood
Melatonin - therapeutic use
Melatonin - urine
Middle Aged
Neurochemistry
Neuropsychology
Neurosciences
original-article
Polysomnography
Quadriplegia - complications
Quadriplegia - drug therapy
Quadriplegia - psychology
Quality of Life
Sleep Wake Disorders - blood
Sleep Wake Disorders - drug therapy
Sleep Wake Disorders - etiology
Sleep Wake Disorders - urine
Surveys and Questionnaires
title Sleep disruption in tetraplegia: a randomised, double-blind, placebo-controlled crossover trial of 3 mg melatonin
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