Evidence map›Paper›PMID 29347988›Full record

Trial reportBMC medicine2018

Efficacy of melatonin for sleep disturbance following traumatic brain injury: a randomised controlled trial.

Natalie A Grima, Shantha M W Rajaratnam, Darren Mansfield, Tracey L Sletten, Gershon Spitz, Jennie L Ponsford

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC medicine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03659760 (Does Light and Noise Isolation Change the Melatonin Levels and Inflammatory Response After Cranial Surgery in an Intensive Care Unit), which is not on this map. Cited by 46 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
46citing papers in PubMed, 6 pooled it
17.9field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03659760 nacompletednot on this map

Does Light and Noise Isolation Change the Melatonin Levels and Inflammatory Response After Cranial Surgery in an Intensive Care Unit

TypeinterventionalSponsorDiskapi Yildirim Beyazit Education and Research HospitalRan2018 to 2019Enrolled41ConditionsCranial Nerve DiseasesArmsGroup Isolated
3 · Its place in the literature

Who cites it

46 citing papers in PubMed, 6 syntheses or guidelines pooled it, 153 citations in OpenAlex.

  1. Pooled it
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  11. Poorer sleep quality predicts melatonin response in patients with traumatic brain injury: findings from a randomized controlled trial.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2021
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  15. Review
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  17. Melatonin: A Review of the Evidence for Use in Hospital Settings.Pharmacology research & perspectives · 2025
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 4 institutions in 2 countries.

Natalie A GrimaBeth Israel Deaconess Medical Center, 330 Brookline Avenue, Boston, 02215, MA, USA.
Shantha M W RajaratnamSchool of Psychological Sciences, Monash University, 18 Innovation Walk, Clayton Campus, Wellington Road, Melbourne, Victoria, 3800, Australia.
Darren MansfieldMonash Lung and Sleep, Monash Health, 246 Clayton Road, Clayton, Victoria, 3800, Australia.
Tracey L SlettenSchool of Psychological Sciences, Monash University, 18 Innovation Walk, Clayton Campus, Wellington Road, Melbourne, Victoria, 3800, Australia.
Gershon SpitzSchool of Psychological Sciences, Monash University, 18 Innovation Walk, Clayton Campus, Wellington Road, Melbourne, Victoria, 3800, Australia.
Jennie L PonsfordSchool of Psychological Sciences, Monash University, 18 Innovation Walk, Clayton Campus, Wellington Road, Melbourne, Victoria, 3800, Australia. jennie.ponsford@monash.edu.
Monash University · AUBeth Israel Deaconess Medical Center · USEpworth Hospital · AUMonash Health · AU

Funding

National Health and Medical Research Council (AU) 1028733
6 · The paper itself

Abstract

backgroundThe study aimed to determine the efficacy of melatonin supplementation for sleep disturbances in patients with traumatic brain injury (TBI).

methodsThis is a randomised double-blind placebo-controlled two-period two-treatment (melatonin and placebo) crossover study. Outpatients were recruited from Epworth and Austin Hospitals Melbourne, Australia. They had mild to severe TBI (n = 33) reporting sleep disturbances post-injury (mean age 37 years, standard deviation 11 years; 67% men). They were given prolonged-release melatonin formulation (2 mg; Circadin®) and placebo capsules for 4 weeks each in a counterbalanced fashion separated by a 48-hour washout period. Treatment was taken nightly 2 hours before bedtime. Serious adverse events and side-effects were monitored.

resultsMelatonin supplementation significantly reduced global Pittsburgh Sleep Quality Index scores relative to placebo, indicating improved sleep quality [melatonin 7.68 vs. placebo 9.47, original score units; difference -1.79; 95% confidence interval (CI), -2.70 to -0.88; p ≤ 0.0001]. Melatonin had no effect on sleep onset latency (melatonin 1.37 vs. placebo 1.42, log units; difference -0.05; 95% CI, -0.14 to 0.03; p = 0.23). With respect to the secondary outcomes, melatonin supplementation increased sleep efficiency on actigraphy, and vitality and mental health on the SF-36 v1 questionnaire (p ≤ 0.05 for each). Melatonin decreased anxiety on the Hospital Anxiety Depression Scale and fatigue on the Fatigue Severity Scale (p ≤ 0.05 for both), but had no significant effect on daytime sleepiness on the Epworth Sleepiness Scale (p = 0.15). No serious adverse events were reported.

conclusionsMelatonin supplementation over a 4-week period is effective and safe in improving subjective sleep quality as well as some aspects of objective sleep quality in patients with TBI.

trial registrationIdentifier: 12611000734965; Prospectively registered on 13 July 2011.

Indexed as

ActigraphyAdultAnxietyAustraliaBrain Injuries, TraumaticCross-Over StudiesDouble-Blind MethodFemaleHumansMaleMelatoninSleep Aids, PharmaceuticalSleep Wake DisordersSurveys and QuestionnairesMelatoninSleep Aids, PharmaceuticalAcquired brain injuryInsomniaSleepTraumatic brain injury

Identifiers

PMID29347988
PMCPMC5774131
OpenAlexW2783361034

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.