Clinical Trials Directory

Trials / Suspended

SuspendedNCT02073344

Effect of Beginning a Renal Replacement Therapy on Obstructive Sleep Apnea in End Stage Renal Disease Patients

Prospective Interventional Study Investigating the Effect of Beginning a Renal Replacement Therapy on Obstructive Sleep Apnea and Its Correlation With Overhydration, in End Stage Renal Disease Patients

Status
Suspended
Phase
N/A
Study type
Interventional
Enrollment
30 (estimated)
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 beginning a renal replacement therapy on fluid overload and its consequence on the severity of obstructive sleep apnea, in patients with end stage chronic kidney disease. It aims further to investigate the relationship between overhydration, nocturnal rostral fluid shift and the severity of sleep apnea.

Detailed description

The prevalence of obstructive sleep apnea increases with progressing renal insufficiency. Recent observations suggest a causative relationship between overnight fluid displacement from the legs to the neck soft tissues and the severity of obstructive sleep apnea. We suspect that this pathophysiologic mechanism could explain the increased prevalence of obstructive sleep apnea in patients with fluid overload, including chronic renal failure. The beginning of a renal replacement therapy modify the fluid balance of the end stage renal disease patients and could therefore impact on the severity of sleep apnea in this population. The purpose of this trial is to investigate the hypothesis that the transition from untreated end stage renal disease and a renal replacement therapy decreases the severity of sleep apnea, by a reduction of the fluid overload and of the nocturnal rostral fluid shift. The severity of obstructive sleep apnea is measured by two attended polysomnographies (PSG), a baseline PSG performed before and a follow-up PSG performed 6 month after beginning of a renal replacement therapy. Overhydration and leg fluid are evaluated by bioimpedance, performed at the beginning and at the end of each polysomnography. Patients who have not yet begun a renal replacement therapy 6 months after the baseline PSG will be re-assessed and will be analyzed as control group

Conditions

Interventions

TypeNameDescription
PROCEDURERenal replacement therapyintermittent hemodialysis or peritoneal dialysis
OTHERno interventionno renal replacement therapy

Timeline

Start date
2014-03-01
Primary completion
2021-11-01
Completion
2022-11-01
First posted
2014-02-27
Last updated
2020-08-05

Locations

1 site across 1 country: Switzerland

Source: ClinicalTrials.gov record NCT02073344. Inclusion in this directory is not an endorsement.