The effect of cranial electrotherapy stimulation on sleep in healthy women.

Objective: Cranial electrotherapy stimulation (CES) is considered to be a potential treatment for insomnia. Women are more likely to suffer from insomnia than men. Therefore we studied the effect of CES on sleep efficiency in young healthy women.

Methods: A randomized, controlled clinical study was conducted on 40 women (age 18-35 years) without sleep disorders. Each subject underwent two nights of polysomnography in a sleep center. During the second night, we applied CES with a commercial device (Alpha-Stim 100) using either active or sham stimulation (double-blinded). Sleep was evaluated with respect to differences between the active and sham modes. Sleep electroencephalogram (EEG) analysis was applied to determine frequency changes.

Results: In our study we found no evidence of any direct influence of the Alpha-Stim 100 on sleep. After application of CES, we determined no significant differences between the active group and the control group (sham). Using EEG spectral analysis there was evidence of a frequency-lowering influence on the low-α frequency band (8-10 Hz).

Conclusions: At most we may assume a reproducible effect on the α frequency measured in the EEG for application of CES with current levels  >100 µA and presumably also with frequencies  >0.5 Hz, with application directly at the cranium. We found no influence on sleep parameters. The effect on the low-α band evidenced in quantitative EEG analysis would require further investigation in a study with sufficient effect size.

Significance: This is the first study to investigate the effects of CES with polysomnography during and after therapy. Our study contributes to the few controlled trials that have been conducted to study CES and its effects on the EEG α band. Highlights • This is the first study to investigate the effects of the Alpha-Stim in polysomnography during and subsequent to therapy. • In a quantitative electroencephalogram analysis we studied the data obtained for systematic changes. • To minimize placebo effects in patients with sleep disorders, we conducted the tests on subjects without such disorders.