Sleep disruption in quadriplegia, its hormonal basis and a randomized controlled trial (RCT) of melatonin supplementation

INTERVENTION: 3 week within subject trial of daily evening administration of 3mg melatonin delivered orally. Randomised, double‐blind, placebo controlled trial with two‐week washout period between intervention and placebo treatments CONDITION: Chronic complete quadriplegia Unrefreshed sleep PRIMARY OUTCOME: Improved subjective sleep experience measured by a daily sleep diary and the Basic Nordic Sleepiness Questionnaire and the Sleep Disturbance Severity Scale SECONDARY OUTCOME: Improved Quality of life as measured by the Assessment of Quality of Life Questionnaire, the Hospital Anxiety Depression Scale and the Profile of Moods States Improved autonomic functioning as assessed by a portable blood pressure and heart rate monitor, Orthostatic Hypotension Questionnaire and urine catecholamine and electrolyte levels Improved phasing of sleep as measured by polysomnography INCLUSION CRITERIA: Complete (motor and sensory) quadriplegia (T1 or higher lesion), time since spinal cord injury is greater than one year (chronic)