Effect of Intermittent Hemodialysis on Sleep Apnea Syndrome 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 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
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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.

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

Conditions
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Obstructive Sleep Apnea, Overhydration, End Stage Renal Disease

Intervention / Treatment
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* Procedure: Hemodialysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: moderate to severe obstructive sleep apnea syndrome, with an apnea-hypopnea index (AHI) ≥ 15/h age ≥ 18 years patient with end stage renal disease on chronic intermittent hemodialysis Exclusion criteria: unstable congestive heart failure pace-maker 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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>the first polysomnography (PSG) is performed before hemodialysis (HD), followed by a post-HD PSG on the subsequent night | Procedure: Hemodialysis<br>* Intermittent ambulatory hemodialysis session, according to the patient usual protocol (defined by the treating nephrologist independently of the study)<br>|
| Experimental: Group B<br>the first PSG is performed after hemodialysis (HD), followed by a pre-HD PSG, on the subsequent night | Procedure: Hemodialysis<br>* Intermittent ambulatory hemodialysis session, according to the patient usual protocol (defined by the treating nephrologist independently of the study)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of the obstructive sleep apnea severity | Reduction of the obstructive sleep apnea severity, measured by attended polysomnography, after an ambulatory hemodialysis session | two nights (before and after an ambulatory hemodialysis session) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in nocturnal leg fluid volume shift between the legs and the neck | Reduction in nocturnal leg fluid volume shift between the legs and the neck, measured by bioimpedance and neck circumference after an ambulatory hemodialysis session | two nights (before and after an ambulatory hemodialysis session) | 
| relationship between overhydration, leg fluid volume shift, ankle and neck circumference and the severity of obstructive sleep apnea syndrome | relationship between overhydration (measured by bioimpedance), leg fluid volume shift, ankle and neck circumference and the severity of obstructive sleep apnea syndrome | one night | 
| severity of the periodic limb movement disorder (PLMD) | severity of the periodic limb movement disorder (PLMD) | two nights (before and after one hemodialysis session) | 
| severity of central sleep apnea syndrome | severity of central sleep apnea syndrome | two nights (before and after one hemodialysis session) | 

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