Clinical Trials Directory

Trials / Completed

CompletedNCT01860209

Effect of Intermittent Hemodialysis on Sleep Apnea Syndrome in End Stage Renal Disease Patients

Effect of Intermittent Hemodialysis on Sleep Apnea Syndrome and Its Correlation to Nocturnal Rostral Fluid Shift, in End Stage Renal Disease Patients

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
20 (actual)
Sponsor
Centre Hospitalier Universitaire Vaudois · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREHemodialysisIntermittent ambulatory hemodialysis session, according to the patient usual protocol (defined by the treating nephrologist independently of the study)

Timeline

Start date
2013-03-01
Primary completion
2013-10-01
Completion
2013-10-01
First posted
2013-05-22
Last updated
2013-12-20

Locations

1 site across 1 country: Switzerland

Source: ClinicalTrials.gov record NCT01860209. Inclusion in this directory is not an endorsement.