Modest Effects of Neurofeedback-Assisted Meditation Using a Wearable Device on Stress Reduction: A Randomized, Double-Blind, and Controlled Study.

BACKGROUND: To evaluate the therapeutic effectiveness and safety of a neurofeedback wearable device for stress reduction. METHODS: A randomized, double-blind, controlled study was designed. Participants had psychological stress with depression or sleep disturbances. They practiced either neurofeedback-assisted meditation (n = 20; female, 15 [75.0%]; age, 49.40 ± 11.76 years) or neurofeedback non-assisted meditation (n = 18; female, 11 [61.1%]; age, 48.67 ± 12.90 years) for 12 minutes twice a day for two weeks. Outcome variables were self-reported questionnaires, including the Korean version of the Perceived Stress Scale, Beck Depression Inventory-II, Insomnia Severity Index, Pittsburgh Sleep Quality Index, and State Trait Anxiety Index, quantitative electroencephalography (qEEG), and blood tests. Satisfaction with device use was measured at the final visit. RESULTS: The experimental group had a significant change in PSS score after two weeks of intervention compared with the control group (6.45 ± 0.95 vs. 3.00 ± 5.54, P = 0.037). State anxiety tended to have a greater effect in the experimental group than in the control group (P = 0.078). Depressive mood and sleep also improved in each group, with no significant difference between the two groups. There were no significant differences in stress-related physiological parameters, such as stress hormones or qEEG, between the two groups. Subjective device satisfaction was significantly higher in the experimental group than in the control group (P = 0.008). CONCLUSION: Neurofeedback-assisted meditation using a wearable device can help improve subjective stress reduction compared with non-assisted meditation. These results support neurofeedback as an effective adjunct to meditation for relieving stress. TRIAL REGISTRATION: Clinical Research Information Service Identifier: KCT0007413.

Efficacy of cranial electrotherapy stimulation on mood and sense of well-being in people with subclinical insomnia.

Cranial electrotherapy stimulation is a non-invasive brain stimulation method characterised by using a microcurrent. The objective of the study was to investigate whether a novel device with a stable supplement of electronic stimulation would improve sleep and the accompanying mood symptoms in people with subclinical insomnia. People who had insomnia symptoms without meeting the criteria for chronic insomnia disorder were recruited and randomly assigned to an active or a sham device group. They were required to use the provided device for 30 min each time, twice a day for 2 weeks. Outcome measures included questionnaires for sleep, depression, anxiety, and quality of life, 4 day actigraphy, and 64-channel electroencephalography. Fifty-nine participants (male 35.6%) with a mean age of 41.1 ± 12.0 years were randomised. Improvement of depression (p = 0.032) and physical well-being (p = 0.041) were significant in the active device group compared with the sham device group. Anxiety was also improved in the active device group, although the improvement was not statistically significant (p = 0.090). Regarding sleep, both groups showed a significant improvement in subjective rating, showing no significant group difference. The change in electroencephalography after the 2 week intervention was significantly different between the two groups, especially for occipital delta (p = 0.008) and beta power (p = 0.012), and temporo-parieto-occipital theta (p = 0.022). In conclusion, cranial electrotherapy stimulation can serve as an adjunctive therapy to ameliorate psychological symptoms and to alter brain activity. The effects of the device in a clinical population and an optimal set of parameters of stimulation should be further investigated.

Effects of cranial electrotherapy stimulation on improving depressive symptoms in people with stress: A randomized, double-blind controlled study.

BACKGROUND: Cranial electrotherapy stimulation (CES) is a form of neurostimulation that delivers alternating microcurrent via electrodes on the head. We investigated the effectiveness of CES in reducing stress. METHODS: Participants who experienced subjective stress combined with subclinical depression or insomnia were recruited based on interviews and questionnaires. The subjects were randomly assigned to the active CES or sham groups and asked to use the device for 30 min twice a day for three weeks. Psychological rating scales, quantitative electroencephalography (QEEG), and serial salivary cortisol levels were measured before and after the intervention. RESULTS: Sixty-two participants (58 females, mean age = 47.3 ± 8.2 years) completed the trial. After intervention, the depression scores improved significantly to a nearly normal level (Beck depression inventory-II, 31.3 ± 11.6 to 10.8 ± 7.2, p < 0.001) in the CES group, which were greater improvement compared to the sham group (p = 0.020). There were significant group-by-visit interactions in absolute delta power in the temporal area (p = 0.033), and theta (p = 0.038), beta (p = 0.048), and high beta power (p = 0.048) in the parietal area. CES led to a flattening of the cortisol slope (p = 0.011) and an increase in bedtime cortisol (p = 0.036) compared to the sham group. LIMITATIONS: Bias may have been introduced during the process because device use and sample collection were self-conducted by participants at home. CONCLUSIONS: CES can alleviate depressive symptoms and stress response, showing a potential as an adjunctive therapy for stress.

The effect of proto-type wearable light-emitting devices on serum 25-hydroxyvitamin D levels in healthy adults: a 4-week randomized controlled trial.

BACKGROUND: Many people in modern society have insufficient exposure to ultraviolet B (UVB) sunlight, which may lead to vitamin D deficiency. We aimed to investigate the effect of a proto-type wearable light-emitting diode (LED) device emitting UVB light on serum 25-hydroxyvitamin D levels. METHODS: A total of 136 healthy adults were randomly assigned to receive either an active device emitting UVB light with a peak wavelength of 285 nm (n = 64) or a sham device emitting visible light (n = 72). All participants wore the device for a total of two minutes, one minute on each forearm, every day for 4 weeks. Serum 25-hydroxyvitamin D levels were assessed at baseline, 2, and 4 weeks of intervention, and 2 weeks after the end of the intervention. RESULTS: A significant difference was found between the experimental and control groups in changes in serum 25-hydroxyvitamin D levels from baseline after two (0.25 ± 3.10 ng/mL vs. -1.07 ± 2.68 ng/mL, p = 0.009) and 4 weeks of intervention (0.75 ± 3.98 ng/mL vs. -1.75 ± 3.04 ng/mL, p < 0.001). In the experimental group, the dropout rate due to mild, self-limiting adverse skin reactions was 11.8% (9/76). The mean total 25-hydroxyvitamin D production after UVB exposure was estimated at 0.031 ng/mL per 1 cm2 of skin area. CONCLUSIONS: A prototype wearable LED UVB device was effective for improving 25-hydroxyvitamin D status. The development of a safer wearable LED device for phototherapy may provide a novel daily, at-home option for vitamin D supplementation.

Comparison of autonomous sensory meridian response and binaural auditory beats effects on stress reduction: a pilot study.

This study aimed to compare the effects of Autonomous sensory meridian response (ASMR) and binaural beat (BB) on stress reduction, and to determine whether ASMR and BB can induce changes in quantitative electroencephalography (QEEG). A double-blind randomized trial was conducted. Subjects with stress were recruited considering their perceived stress scale (PSS), Beck depression inventory-II (BDI-II), insomnia severity index (ISI), and state-trait anxiety inventory-state anxiety (STAI-S) scores. Subjects listened to ASMR or BB with music (8 Hz for daytime, 5 Hz for nighttime) for 15 min in daytime and 30 min before going to sleep for 3 weeks. QEEG was measured before and after the intervention. Seventy-six participants (57 female, mean age = 46.12 ± 12.01) finished the trial. After the intervention, PSS, BDI-II, ISI, STAI-S, and PSQI scores improved significantly in both groups. BDI-II and ISI mean scores were normalized in both groups after the intervention. Changes of absolute beta and high beta power in the ASMR group were larger than those in the BB group (p = 0.026, p = 0.040, respectively). Both ASMR and BB are equally effective in reducing stress levels. Unlike BB, ASMR can lead to an increase in beta and high beta waves associated with cortical arousal.

Age-Limited Effects of Low-Frequency Transcutaneous Electric Nerve Stimulation on Insomnia: A 4-Week Multi-Center, Randomized Controlled Study.

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.