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KMID : 1118520220190060451
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Psychiatry Investigation
2022 Volume.19 No. 6 p.451 ~ p.461
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Age-Limited Effects of Low-Frequency Transcutaneous Electric Nerve Stimulation on Insomnia: A 4-Week Multi-Center, Randomized Controlled Study
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Lee Hyuk-Joo
Hong Jung-Kyung
Choi Ha-Yun
Chung Seock-Hoon
Yoon In-Young
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Abstract
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Objective: Insomnia disorder is a common condition with considerable harmful effects on health. We investigated the therapeutic efficacy and safety of low-frequency transcutaneous electric nerve stimulation (LF-TENS) as an alternative treatment option for insomnia disorder.
Methods: A 4-week, multi-center, randomized controlled study was conducted. A total of 160 individuals aged 40 to 80 years with insomnia disorder were included and randomized to the experimental group receiving active device (n=81) or control group receiving sham device (n=79). Both groups used the device for four weeks, more than five days a week. The participants also completed pre- and post-intervention assessment with questionnaires, sleep diaries, wrist actigraphy, and blood tests.
Results: There was no significant between-group difference in the changes of mood and sleep parameters and blood test results among the two study groups. Meanwhile, in the exploratory sub-group analysis of patients aged over 60 years, the experimental group showed better improvement after intervention in the change of Pittsburgh Sleep Quality Index (PSQI) score (-2.63±3.25 vs. -1.20±2.28, p=0.039; Cohen’s d=0.99 vs. 0.45) and blood cortisol level (-1.65±3.37 μg/dL vs. -0.16±3.49 μg/dL, p=0.007; Cohen’s d=0.56 vs. 0.05). In addition, no serious adverse reaction occurred during the study period in both groups.
Conclusion: The effect of LF-TENS was limited to older patients aged over 60 years, which might be related to the modulation of hypothalamic-pituitary-adrenal axis activity.
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KEYWORD
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Cortisol, Electrical stimulation, Sleep quality, Insomnia, Transcutaneous electric nerve stimulation
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