![]() Sleep quality was measures by a 10 point numerical rating scale. The Profile of Moods (POMS) subscale A was used to measure anxiety and the POMS subscale D was used to measure depression. ![]() The subjects, investigators, physicians and staff were all masked as to the identity of the device. The sham device was identical in appearance to the active CES unit, but used ear clips made for this study that did not conduct an electrical current. The active CES device was set to 100 ♚, a subsensory level. Subjects were randomly assigned into 3 separate groups, ether active CES at a subsenate level, sham group or control by drawing subjects names out of a container. At the completion of the 3 week open label crossover arm, subjects were retested on study outcome measures. Subjects used the CES device daily for 1 hour for 3 weeks. 23 of the 40 subjects in the sham group elected to participate in the open label crossover arm. Open label crossover arm: At this time blinding was broken and subjects in the sham and control groups were given the option to receive active CES for 3 weeks.At the end of 3 weeks, the subjects returned to the clinic, and outcome measures were repeated. Following the baseline tests, subjects were taught to use the CES device, and were instructed to use it every day for one hour over the 3 week period. RCT arm: 3 weeks of treatment with either the active CES device or the sham device.No change was made in the medical management of the patient during the study. ![]() The measurements of primary effectiveness endpoint were taken at baseline, prior to start of treatment period. Protocol Summary Randomization assignment was established prior to the start of the study.
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