Melatonin Is a Feasible, Safe, and Acceptable Intervention in Doctors and Nurses Working Nightshifts: The MIDNIGHT Trial

Abstract

Nightshift working is associated with sleep deprivation, fatigue and attention/ concentration deficits which, in healthcare workers, may impact on patient safety. Clinical staff in the UK routinely work several 12 h nightshifts in a row at about 1-3 month intervals. We investigated the feasibility and acceptability of a crossover trial of melatonin administration in clinical staff working nightshifts with an exploration of effects on sleep measures and attention/concentration tasks. This was a pilot, double-blinded, randomized, placebo-controlled crossover feasibility trial in doctors and nurses working 3 consecutive nightshifts at a tertiary referral hospital in the UK. Twenty five male and female subjects were randomized to receive either 6mg Circadin™ slow release melatonin or placebo before sleep after each consecutive nightshift, followed by a washout period, before crossing over to the other experimental arm. We used actigraphy for objective assessment of sleep parameters. The trial design was feasible and acceptable to participants with negligible side effects, but elevated melatonin levels were prolonged during the active arm (P=0.016). Double digit addition testing, a concentration/attention task, improved with melatonin treatment (P<0.0001). Lapses of vigilance or judgement while doctors or nurses are working nightshifts could impact on patient safety and melatonin may be a useful intervention. This study supports the conclusion that a larger definitive trial of this design is both feasible and safe.

Maternal Serum Melatonin Increases During Pregnancy and Falls Immediately After Delivery Implicating the Placenta as a Major Source of Melatonin

“…Of key clinical interest is whether low levels of melatonin may have a role in diseases of pregnancy. Administration of exogenous melatonin appears free of side effects in healthy non-pregnant subjects ( 20 , 31 ) and an open label phase I single arm trial of exogenous melatonin in women with pre-eclampsia reported that melatonin was safe for mothers and fetuses ( 5 ). Exactly how melatonin may be involved in the pathophysiology of pregnancy is vital to before moving on to ascertain the potential for exogenous melatonin as a therapy to prevent adverse obstetric outcomes.…”

Extent of sleep problems and relationship with severity of chronic pain using three validated sleep assessment tools

“…In healthy subjects, VSH disturbance scores are reported to be around 100-200. 14,15 Conversely, more than 60% of our participants had an efficiency score of <300 out of 600, and nearly one quarter (n=12) had a score of <150. Again, these scores are considerably lower than in people without chronic pain.…”

Objective Assessment of Sleep Patterns among Night-Shift Workers: A Scoping Review

“…After reviewing the full text, we selected a final list of 32 studies ( Figure 1 ). Of these, 15 (46.9%) were cross-sectional surveys [ 9 , 10 , 11 , 12 , 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 ], 11 (34.4%) were RCTs [ 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 ], 4 (12.5%) were quasi-experimental studies [ 35 , 36 , 37 , 38 ], and 2 (6.3%) were cohort design studies [ 39 , 40 ].…”

“…Overall, 2822 adults were included in the final 32 studies. The study population of night-shift workers included health care workers (n = 18, 56.3%) [ 10 , 12 , 13 , 15 , 18 , 21 , 24 , 25 , 27 , 29 , 31 , 32 , 33 , 35 , 36 , 38 , 39 , 40 ], production workers (n = 6, 18.8%) [ 11 , 14 , 19 , 20 , 22 , 30 ], transportation workers (n = 3, 9.4%) [ 17 , 20 , 28 ], mixed types of workers (n = 1, 3.1%) [ 23 ] and no specific types of workers (n = 4, 12.5%) [ 9 , 16 , 26 , 34 ].…”

“…Most studies (n = 24, 75%) [ 10 , 11 , 12 , 13 , 15 , 16 , 17 , 18 , 20 , 21 , 23 , 24 , 25 , 27 , 28 , 29 , 30 , 31 , 33 , 34 , 35 , 36 , 39 , 40 ] were published after 2011. The study types encompassed intervention evaluation studies (n = 15, 46.9%) [ 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 ], observational studies (n = 16, 50%) [ 9 , 10 , 11 , 12 , 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 39 ,…”