Poorer sleep quality predicts melatonin response in patients with traumatic brain injury: findings from a randomized controlled trial.
Study Goal
The researchers aimed to identify predictors of treatment response to melatonin in improving sleep quality among patients with traumatic brain injury (TBI).
Results Summary
The study found that baseline sleep quality (measured by PSQI) was the only significant predictor of melatonin's effectiveness, with poorer baseline sleep quality associated with greater improvement. Other factors like fatigue, mood, and anxiety did not significantly influence treatment response.
Population
Patients with predominantly severe TBI and comorbid insomnia.
Effective Dosage
Not specified
Duration
Not specified
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
melatonin treatment | increase | self-perceived sleep quality | patients with traumatic brain injury (TBI) | - | was effective in improving | #1 |
melatonin treatment | increase | self-reported sleep quality scores (follow-up minus baseline score) as assessed by the Pittsburgh Sleep Quality Index (PSQI) | - | 32% | explained an additional 32% of the variance in change | #2 |
melatonin treatment | decrease | change in PSQI scores | - | β = -0.56 | made a unique and statistically significant contribution | #3 |
melatonin treatment | increase | sleep quality | participants who report poorer sleep quality in a sample comprising predominantly severe TBI and comorbid insomnia | - | have the most to gain from | #4 |
STUDY OBJECTIVES: 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. METHODS: 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). RESULTS: 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, CONCLUSIONS: In a sample comprising predominantly severe TBI and comorbid insomnia, participants who report poorer sleep quality have the most to gain from melatonin treatment irrespective of time since injury, demographics, fatigue, daytimes sleepiness, mood, and anxiety symptomology. CLINICAL TRIAL REGISTRATION: Registry: Australian New Zealand Clinical Trials Registry; Name: Efficacy of Melatonin for Sleep Disturbance Following Traumatic Brain Injury; URL: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=343083&showOriginal=true&isReview=true; Identifier: ACTRN12611000734965. CITATION: Grima NA, Rajaratnam SMW, Mansfield D, McKenzie D, Ponsford JL. Poorer sleep quality predicts melatonin response in patients with traumatic brain injury: findings from a randomized controlled trial.