LAWRENCE, Mass.—Patients showed a significant improvement in overall sleep quality, and marked improvement in restless leg syndrome after four months of daily home hemodialysis using the System One machine, according to the latest results of an ongoing study by NxStage.
The interim results from the FREEDOM study compared patients' responses to the Medical Outcomes Study (MOS) Sleep Survey and the International RLS Study Group Rating Scale (IRLS) at baseline and four months. Specifically, significant improvements identified in this planned interim analysis included:
•Overall sleep quality (as measure by the MOS Sleep Problems Indices I and II) significantly improved from baseline to month four. (Index I: P=<0.001; Index II: P<0.0001)
•Four of the 5 individual sleep scales—sleep adequacy, daytime somnolence (or "drowsiness"), sleep initiation and maintenance, and respiratory disturbances—displayed significant improvement.
•There was a significant reduction in the number of patients reporting RLS at 4 months compared to baseline. (P=0.02)
•Of those patients who experienced RLS at baseline (n=58), 36 percent no longer experienced RLS at month four.
"Various studies suggest a high prevalence of sleep-related disorders and RLS, among end-stage renal disease (ESRD) patients. These interim results from the ongoing FREEDOM study demonstrate the positive impact of daily home hemodialysis on these disorders, which can have a significant impact on patients' quality of life," said Brigitte Schiller, MD, acting chief medical officer and vice president of scientific affairs for Satellite Healthcare.
"Quality sleep is essential, and to ESRD patients in particular, as it has been proven to affect other areas of patients' overall health," she added. "Although these findings are only at four months, longer-term follow up is underway to determine whether the positive impact of daily home dialysis on sleep patterns and RLS persists at one year."