임상시험 중 수면행위가 심박변이도에 미치는 영향 분석

Assessment of covariate-effect of sleeping behavior on heart rate variability during a clinical trial

The object of this study is to evaluate confounding effect of sleeping behavior on heart rate variability (HRV) in healthy volunteers during a randomized clinical trial. From 6 healthy volunteer, we acquired circadian electrocardiography(ECG) with a Holter monitoring device(DigiTrak Plus, Philips). The compatible analytical program, Zymed, was used for calculation of RR intervals of 24h ECG signal. Then, we generated HRV signals and calculated 9 HRV parameters in time domain and frequency domain for every 30 minute with Matlab 6.x software. We also encoded participants' activities as follows; stable condition(1), sleeping behavior(2), eating behavior(3), and undefined condition(4). Using SPSS 12.0, we tested if there was any difference between HRV parameters of day-time and night-time and between those of a subject in stable condition and in sleeping behavior. As a result, one of the most important parameter-LF/HF ratio, which indicates the autonomic balance between sympathetic and parasympathetic nervous systems, as same the other parameters, showed large inter-individual variations in circadian profiles. And, the mean LF/HF ratio of each participant was different between in stable condition and in sleeping behavior (p<.05). Consequently, the effect of sleeping behavior must be considered when one or more of HRV parameters, especially LF/HF ratio, are used as assessment index in clinical studies.