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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intevention group | Experimental | A baseline polysomnography (PSG) is performed at inclusion, followed by a follow-up PSG 6 months after the beginning of a renal replacement therapy |
|
| Control group | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Renal replacement therapy | Procedure | intermittent hemodialysis or peritoneal dialysis |
| |
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raphaël Heinzer, MD | Centre d'Investigation et Recherche sur le Sommeil (CIRS) - Centre Hospitalier Universitaire Vaudois (CHUV) | Principal Investigator |
| Adam Ogna, MD | Centre d'Investigation et Recherche sur le Sommeil (CIRS) - Centre Hospitalier Universitaire Vaudois (CHUV) | Principal Investigator |
| Valentina Forni Ogna, MD | Centre d'Investigation et Recherche sur le Sommeil (CIRS) - Centre Hospitalier Universitaire Vaudois (CHUV) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre d'Investigation et Recherche sur le Sommeil (CIRS) - Centre Hospitalier Universitaire Vaudois (CHUV) | Lausanne | Canton of Vaud | 1011 | Switzerland |
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| no intervention |
| Other |
no renal replacement therapy |
|
| 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) |
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D007676 | Kidney Failure, Chronic |
| D014869 | Water Intoxication |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| D017582 | Renal Replacement Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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