Effect of Renal Transplantation on Obstructive Sleep Apnea in End Stage Renal Disease Patients (SASinTx)

Study Overview
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Brief Summary
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The purpose of this study is to investigate the effect of renal transplantation 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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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 fluid overload, including chronic renal failure. The purpose of this study is to investigate the effect of renal transplantation 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. The severity of obstructive sleep apnea is measured by two attended polysomnographies, a baseline PSG performed before and a follow-up PSG performed 6 month after renal transplantation. Overhydration and leg fluid are evaluated by bioimpedance, performed at the beginning and at the end of each polysomnography. Patients who are not already transplanted 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 Renal Transplantation on Obstructive Sleep Apnea 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, Renal Transplantation

Intervention / Treatment
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* Procedure: Renal transplantation


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 on waiting list for a renal transplantation (cadaveric or live donor). 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: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>A baseline polysomnography (PSG) is performed at inclusion (before renal transplantation, Tx), followed by a post-Tx PSG 6 months after transplantation | Procedure: Renal transplantation<br>* Renal transplantation from cadaveric or live donor<br>|
| No Intervention: Control Group<br>A baseline polysomnography (PSG) is performed at inclusion, followed by a follow-up PSG at 6 months if the patient is not already transplanted | |

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, six months after renal transplantation | six months after renal transplantation | 

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 six months after renal transplantation | six months after renal transplantation | 
| Relationship between overhydration, leg fluid volume shift, ankle and neck circumference and the severity of obstructive sleep apnea | Relationship between overhydration (measured by bioimpedance), leg fluid volume shift, ankle and neck circumference and the severity of obstructive sleep apnea | at baseline and six months after renal transplantation | 
| Change in the severity of the periodic limb movement disorder (PLMD) | Change in the severity of the periodic limb movement disorder (PLMD) | six months after renal transplantation | 
| Change in the severity of central sleep apnea | Change in the severity of central sleep apnea | six months after renal transplantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neck circumference, polysomnography, bioimpedance, leg fluid shift, Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Sleep Disorders, Intrinsic, Sleep Disorders, Apnea, Kidney Diseases, Kidney Failure, Chronic, Renal Insufficiency, Chronic, Renal Insufficiency, Dyssomnias