Relationship of nocturnal concentrations of melatonin, gamma-aminobutyric acid and total antioxidants in peripheral blood with insomnia after stroke: study protocol for a prospective non-randomized controlled trial

Wei Zhang, Fang Li, Tong Zhang, Wei Zhang, Fang Li, Tong Zhang

Abstract

Melatonin and gamma-aminobutyric acid (GABA) have been shown to regulate sleep. The nocturnal concentrations of melatonin, GABA and total antioxidants may relate to insomnia in stroke patients. In this prospective single-center non-randomized controlled clinical trial performed in the China Rehabilitation Research Center, we analyzed the relationship of nocturnal concentrations of melatonin, GABA and total antioxidants with insomnia after stroke. Patients during rehabilitation of stroke were recruited and assigned to the insomnia group or non-insomnia group. Simultaneously, persons without stroke or insomnia served as normal controls. Each group contained 25 cases. The primary outcome was nocturnal concentrations of melatonin, GABA and total antioxidants in peripheral blood. The secondary outcomes were Pittsburgh Sleep Quality Index, Insomnia Severity Index, Epworth Sleepiness Scale, Fatigue Severity Scale, Morningness-Eveningness Questionnaire (Chinese version), and National Institute of Health Stroke Scale. The relationship of nocturnal concentrations of melatonin, GABA and total antioxidants with insomnia after stroke was analyzed and showed that they were lower in the insomnia group than in the non-insomnia group. The severity of stroke was higher in the insomnia group than in the non-insomnia group. Correlation analysis demonstrated that the nocturnal concentrations of melatonin and GABA were associated with insomnia after stroke. This trial was registered at ClinicalTrials.gov, identifier: NCT03202121.

Keywords: National Institute of Health Stroke Scale; insomnia; melatonin; nerve regeneration; neural regeneration; sleep-related scales; stroke; total antioxidants; γ-aminobutyric acid.

Conflict of interest statement

Conflicts of interest: None declared.

Figures

Figure 1
Figure 1
Clinical trial flow chart.
Figure 2
Figure 2
Nocturnal concentrations of melatonin, γ-aminobutyric acid (GABA) and total antioxidants in peripheral blood. Melatonin and GABA concentrations were measured by ultra-performance liquid chromatography-mass spectrometry and the antioxidant concentration was measured by colorimetric antioxidant assay. Bars indicate the median and interquartile values. Hotelling’s T2 test was performed for statistical analysis. ##P < 0.01.

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