Melatonin effects on sleep quality and outcomes of COVID-19 patients: An open-label, randomized, controlled trial.
Study Goal
The researchers aimed to evaluate the effectiveness of adding melatonin to standard care for improving sleep quality and clinical outcomes in hospitalized COVID-19 patients.
Results Summary
Melatonin significantly improved sleep quality and blood oxygen saturation in hospitalized COVID-19 patients compared to standard care alone, but no significant differences were observed in other secondary endpoints like symptom alleviation, ICU admission, or mortality.
Population
Hospitalized COVID-19 patients
Effective Dosage
Not specified
Duration
Not specified
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
melatonin plus standard care | increase | LSEQ scores | hospitalized COVID-19 patients | - | was significantly higher | #1 |
melatonin plus standard care | increase | blood oxygen saturation | hospitalized COVID-19 patients | 95.81% vs. 93.65% | has improved significantly | #2 |
melatonin plus standard care | no change | symptoms on Day 7 | hospitalized COVID-19 patients | - | no significant difference | #3 |
melatonin plus standard care | no change | laboratory data | hospitalized COVID-19 patients | - | no significant difference | #4 |
oral melatonin tablets and standard treatment | increase | sleep quality | hospitalized COVID-19 patients | - | could substantially improve | #5 |
oral melatonin tablets and standard treatment | increase | blood oxygen saturation | hospitalized COVID-19 patients | - | could substantially improve | #6 |
This trial aims to evaluate the effectiveness of adding melatonin to the treatment protocol of hospitalized coronavirus disease 2019 (COVID-19) patients. This was an open-label, randomized controlled clinical trial in hospitalized COVID-19 patients. Patients were randomized into a treatment arm receiving melatonin plus standard care or a control arm receiving standard care alone. The trial's primary endpoint was sleep quality examined by the Leeds Sleep Evaluation Questionnaire (LSEQ). The trial's secondary endpoints were symptoms alleviation by Day 7, intensive care unit admission, 10-day mortality, white blood cell count, lymphocyte count, C-reactive protein status, and peripheral capillary oxygen saturation. Ninety-six patients were recruited and allocated to either the melatonin arm (n = 48) or control arm (n = 48). Baseline characteristics were similar across treatment arms. There was no significant difference in symptoms on Day 7. The mean of the LSEQ scores was significantly higher in the melatonin group (p < 0.001). There was no significant difference in laboratory data, except for blood oxygen saturation, which has improved significantly in the melatonin group compared with the control group (95.81% vs. 93.65% respectively, p = 0.003). This clinical trial study showed that the combination of oral melatonin tablets and standard treatment could substantially improve sleep quality and blood oxygen saturation in hospitalized COVID-19 patients.