The FREEDOM Study (Impact of Short Daily Hemodialysis on Restless Legs Symptoms and Sleep Disturbances) Source Jaber BL, Schiller B, Burkart JM, et al.

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The FREEDOM Study (Impact of Short Daily Hemodialysis on Restless Legs Symptoms and Sleep Disturbances) Source Jaber BL, Schiller B, Burkart JM, et al. ( FREEDOM Study Group). Impact of short daily hemodialysis on restless legs symptoms and sleep disturbances. Clin J Am Soc Nephrol. 2011;6(5):1049–1056 [Epub. 17 March 2011].

Background Restless leg syndrome is a distressing neurologic disease that causes uncomfortable sensation in the legs with an irresistible urge to move them. RLS affects the sleep quality as it is often associated with periodic limb movement disorder. It is common in patients undergoing maintenance dialysis (prevalence as high as 62%). In patients undergoing dialysis, RLS, and sleep disorder leads to higher morbidity and mortality rates.

Aim To examine the long-term benefits of home short daily hemodialysis (SDHD) on the prevalence and severity of restless leg syndrome (RLS) as measured by the International Restless Legs Syndrome (IRLS) Study Group rating scale, and sleep disturbances measured by the Medical Outcomes Study sleep survey.

Methods

Summary of key results I. Assessment of RLS: Significant improvement in the mean IRLS score at month 12, after adjustment for use of RLS-related medications seen in the per-protocol analysis, among patients with RLS. Percentage of participants reporting RLS decreased significantly from 35% at baseline to 26% at month 12 (P=0.05). Percentage of participants suffering from moderate-to-severe RLS (IRLS score ≥15) decreased from 59% to 43% over the same time period (P=0.06). Among patients with moderate-to-severe RLS (IRLS score ≥15), there was an even greater improvement in the IRLS score. Percentage of participants prescribed RLS-associated medications did not significantly change over the 12-month period (14% vs 18%; P=0.2). II. Assessment of sleep problems: Both sleep problems index 1 and 2 scores decreased by 6–7 points at 4 and 12 months (P=0.001) per-protocol cohort. Sleep adequacy improved significantly by 5–6 points in the ITT cohort at 4 and 12 months; however, the increase was not significant in the per-protocol cohort. No effect on the sleep quantity or gains of percent achieving optimal sleep observed with SDHD.

Conclusion Over 12-month period, initiation of SDHD in the home setting resulted in sustained and clinically meaningful improvement in restless legs symptoms and sleep disturbances. Home SDHD provided long-term improvement in prevalence and severity of RLS.