Table 7.14 Melatonin for the Management of Sleep Disorders Post ABI
| Author Year Country Study Design Sample Size | Methods | Outcome |
| Grima et al. (2018)
Australia RCT Crossover PEDro=9 N=33 |
Population: Melatonin-placebo group (N=18): Mean Age=35yr; Gender: Male=61%, Female=39%; Median Time Post Injury=61mo; Severity: Median GCS= 5. Placebo-melatonin group (N=15): Mean Age=38yr; Gender: Male=73%, Female=27%; Median Time Post Injury= 25mo; Severity: Median GCS=8. Intervention: Participants with chronic insomnia were randomly allocated to a 4wk melatonin or placebo treatment before crossover. Melatonin formula was a prolonged release formula (2mg). Participants were measured at baseline and at the end of each treatment phase. Outcomes: Pittsburgh Sleep Quality Index (PSQI); Sleep onset latency (measured by wrist actigraphy); Epworth Sleepiness Scale (ESS); Hospital Anxiety Depression Scale (HADS); Fatigue Severity Scale (FSS); Short-form health survey (SF-36 v1) subscales: Physical Functioning (PF); Role Physical (RP); Role-emotional (RE); Vitality (VT); Mental Health (MH); Social Functioning (SF); Bodily Pain (BP); General Health (GH). | 1. PSQI scores were significantly better in the melatonin arm compared to the placebo arm (p<0.0001). 2. Sleep latency scores were not significantly different between treatments (p=0.23). 3. Sleep efficiency scores were significantly higher in the melatonin arm compared to the placebo arm (p=0.04). 4. ESS scores were not significantly different between treatments (p=0.15). |