Efficacy of cranial electric stimulation for the treatment of insomnia: a randomized pilot study.
OBJECTIVES
This pilot study examined the potential efficacy of cranial electric stimulation for the treatment of insomnia.


DESIGN
The researchers tested the hypothesis through a randomized, double-blind, and placebo controlled clinical trial. The researchers approached eligible subjects who scored 21 or above on the Pittsburgh Insomnia Rating Scale. The researchers then randomly assigned the subjects to receive either an active or sham device. Each study subject received 60min of active or sham treatment for five days. Following each intervention the subjects completed a sleep log, as well as three and ten days later.


SETTING
The researchers conducted the study among active duty service members receiving mental health care on the Psychiatry Continuity Service (PCS), Walter Reed National Military Medical Center in Bethesda, MD.


MAIN OUTCOME MEASURES
The study's primary outcome variables were the time to sleep onset, total time slept, and number of awakenings as reported by the subjects in the serial sleep logs. The researchers identified a nearly significant increase in total time slept after three cranial electric stimulation treatments among all study subjects. A closer examination of this group revealed an interesting gender bias, with men reporting a robust increase in total time slept after one treatment, decay in effect over the next two interventions, and then an increase in total time slept after the fourth treatment. The researchers speculate that the up and down effect on total time slept could be the result of an insufficient dose of cranial electric stimulation.