Obstructive Sleep Apnea Clinical Trial
Official title:
Effect of Intermittent Hemodialysis on Sleep Apnea Syndrome and Its Correlation to Nocturnal Rostral Fluid Shift, in End Stage Renal Disease Patients
The purpose of this study is to investigate the effect of decreasing fluid overload by hemodialysis on the severity of obstructive sleep apnea, in patients with end stage chronic kidney disease on intermittent hemodialysis. It aims further to investigate the relationship between overhydration, nocturnal rostral fluid shift and the severity of sleep apnea.
Obstructive sleep disordered breathing is more prevalent in end stage kidney disease
patients than in the general population, and may participate to the increased cardiovascular
mortality observed in this group of patients. Despite a significant increase in knowledge
about the harmful effects of obstructive sleep apnea, the pathophysiological mechanisms are
poorly understood. Recent observations suggest a causative relationship between overnight
fluid displacement from the legs to the neck soft and the severity of obstructive sleep
apnea. This mechanism was demonstrated in otherwise healthy subjects, in heart failure
patients, and in patients with venous insufficiency. We thus suspect that this
pathophysiologic mechanism could explain the increased prevalence of obstructive sleep apnea
in patients with hypervolemia, including chronic renal failure.
The purpose of this trial is to investigate the hypothesis that nocturnal rostral fluid ship
is linked to overhydration and participates significantly to the severity of obstructive
sleep apnea in patients on hemodialysis. The correction of overhydration by hemodialysis
should therefore reduce the amount of nocturnally displaced water and consequently lower the
severity of obstructive sleep apnea.
The severity of obstructive sleep apnea is measured by two consecutive attended
polysomnographies, performed before and after an ambulatory hemodialysis session with fluid
removal, whereas overhydration and leg fluid are evaluated by bioimpedance, performed at the
beginning and at the end of each polysomnography. The sequence of the two polysomnographies
with respect to hemodialysis is randomized, to minimize the first-night effect.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
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