Poorer sleep quality predicts melatonin response in patients with traumatic brain injury: findings from a randomized controlled trial
Abstract
A recent clinical trial demonstrated that melatonin treatment was effective in improving self-perceived sleep quality in patients with traumatic brain injury (TBI); however, it remains unclear which patients benefited from melatonin treatment. To that end, findings from the clinical trial were re-examined to identify possible predictors of treatment response. Hierarchical multiple regression was used to identify patient characteristics, TBI injury characteristics, and self-report measures assessing sleep, fatigue, mood, and anxiety symptomatology that may uniquely explain a change in self-reported sleep quality scores (follow-up minus baseline score) as assessed by the Pittsburgh Sleep Quality Index (PSQI). After controlling for patient demographic and TBI injury-related variables, baseline self-report measures of sleep, fatigue, mood, and anxiety explained an additional 32% of the variance in change in PSQI scores. However, only baseline PSQI score made a unique and statistically significant contribution (β = −0.56, P = .006). After controlling for patient and TBI characteristics, baseline PSQI scores further explained 27% of the variance in change in PSQI scores (R2 change = .27, F1, 27 change = 11.79, P = .002). The standardized β for baseline PSQI score revealed a statistically significant negative relationship with change in PSQI score (β = −0.54, P = .002), revealing that higher PSQI score at baseline was associated with better sleep outcomes. In a sample comprising…
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Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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