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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | A baseline polysomnography (PSG) is performed at inclusion (before renal transplantation, Tx), followed by a post-Tx PSG 6 months after transplantation |
|
| Control Group | 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 transplanted |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Renal transplantation | Procedure | Renal transplantation from cadaveric or live donor |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rapahël 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 | Service de Néphrologie et Hypertension - 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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31912961 | Derived | Forni Ogna V, Ogna A, Haba-Rubio J, Nowak G, Venetz JP, Golshayan D, Matter M, Burnier M, Pascual M, Heinzer R. Impact of kidney transplantation on sleep apnea severity: A prospective polysomnographic study. Am J Transplant. 2020 Jun;20(6):1659-1667. doi: 10.1111/ajt.15771. Epub 2020 Jan 21. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 2, 2020 | |
| Reset | Mar 16, 2020 | |
| Release | Aug 3, 2020 |
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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 |
| Reset | Aug 14, 2020 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 2, 2020 | Mar 16, 2020 | |||
| Aug 3, 2020 | Aug 14, 2020 |
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D014869 | Water Intoxication |
| D007676 | Kidney Failure, Chronic |
| D012891 | Sleep Apnea Syndromes |
| D020919 | Sleep Disorders, Intrinsic |
| D012893 | Sleep Wake Disorders |
| D001049 | Apnea |
| D007674 | Kidney Diseases |
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D020920 | Dyssomnias |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D009422 | Nervous System Diseases |
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
| 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 |
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D012818 | Signs and Symptoms, Respiratory |
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| ID | Term |
|---|---|
| D016030 | Kidney Transplantation |
| ID | Term |
|---|---|
| D017582 | Renal Replacement Therapy |
| D013812 | Therapeutics |
| D016377 | Organ Transplantation |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
| D013520 | Urologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
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