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

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Obstructive Sleep Apnea, End Stage Renal Disease

Intervention / Treatment
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* Procedure: Renal replacement therapy
* Other: no intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: moderate to severe obstructive sleep apnea, with an apnea-hypopnea index (AHI) ≥ 15/h age ≥ 18 years patient with end stage renal disease without renal replacement therapy. Exclusion Criteria: unstable congestive heart failure active psychiatric disease amputation of the lower limbs, proximal to the ankle

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intevention group<br>A baseline polysomnography (PSG) is performed at inclusion, followed by a follow-up PSG 6 months after the beginning of a renal replacement therapy | Procedure: Renal replacement therapy<br>* intermittent hemodialysis or peritoneal dialysis<br>|
| Experimental: Control group<br>No intervention A baseline polysomnography (PSG) is performed at inclusion, followed by a follow-up PSG at 6 months if the patient is not already on renal replacement therapy | Other: no intervention<br>* no renal replacement therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| obstructive sleep apnea severity | Reduction of the obstructive sleep apnea severity, measured by attended polysomnography, six months after beginning of a renal replacement therapy | six months (before and after beginning of a renal replacement therapy) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| nocturnal leg fluid volume shift | Reduction in nocturnal leg fluid volume shift between the legs and the neck, measured by bioimpedance and neck circumference six months after beginning of a renal replacement therapy | six months (before and after beginning of a renal replacement therapy) | 
| relationship between overhydration, leg fluid volume shift, ankle and neck circumference and the severity of obstructive sleep apnea |  | one night | 
| periodic limb movement disorder (PLMD) |  | six months (before and after beginning of a renal replacement therapy) | 
| severity of central sleep apnea syndrome |  | six months (before and after renal beginning of a renal replacement therapy) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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polysomnography, renal transplantation, obstructive sleep apnea, overhydration, end stage renal disease, bioimpedance, leg fluid shift, neck circumference