Effect of Renal Transplantation on Obstructive Sleep Apnea in End Stage Renal Disease Patients (SASinTx) (SASinTx)
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| ClinicalTrials.gov Identifier: NCT02020642 |
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Recruitment Status
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Recruiting
First Posted
: December 25, 2013
Last Update Posted
: February 2, 2017
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Obstructive Sleep Apnea Overhydration End Stage Renal Disease Renal Transplantation | Procedure: Renal transplantation | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 36 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Other |
| Official Title: | 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 |
| Study Start Date : | October 2013 |
| Estimated Primary Completion Date : | November 2017 |
| Estimated Study Completion Date : | March 2018 |
| Arm | Intervention/treatment |
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Experimental: Intervention Group
A baseline polysomnography (PSG) is performed at inclusion (before renal transplantation, Tx), followed by a post-Tx PSG 6 months after transplantation
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Procedure: Renal transplantation
Renal transplantation from cadaveric or live donor
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No Intervention: Control Group
A baseline polysomnography (PSG) is performed at inclusion, followed by a follow-up PSG at 6 months if the patient is not already transplanted
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- Reduction of the obstructive sleep apnea severity [ Time Frame: six months after renal transplantation ]Reduction of the obstructive sleep apnea severity, measured by attended polysomnography, six months after renal transplantation
- Reduction in nocturnal leg fluid volume shift between the legs and the neck [ Time Frame: six months after renal transplantation ]Reduction in nocturnal leg fluid volume shift between the legs and the neck, measured by bioimpedance and neck circumference six months after renal transplantation
- Relationship between overhydration, leg fluid volume shift, ankle and neck circumference and the severity of obstructive sleep apnea [ Time Frame: at baseline and six months after renal transplantation ]Relationship between overhydration (measured by bioimpedance), leg fluid volume shift, ankle and neck circumference and the severity of obstructive sleep apnea
- Change in the severity of the periodic limb movement disorder (PLMD) [ Time Frame: six months after renal transplantation ]Change in the severity of the periodic limb movement disorder (PLMD)
- Change in the severity of central sleep apnea [ Time Frame: six months after renal transplantation ]Change in the severity of central sleep apnea
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02020642
| Contact: Raphaël Heinzer, MD | +41 21 314 67 48 | raphael.heinzer@chuv.ch | |
| Contact: Adam Ogna, MD | +41 21 314 67 48 | adam.ogna@chuv.ch |
| Switzerland | |
| Centre d'Investigation et Recherche sur le Sommeil (CIRS) - Centre Hospitalier Universitaire Vaudois (CHUV) | Recruiting |
| Lausanne, Vaud, Switzerland, 1011 | |
| Contact: Raphaël Heinzer, MD +41 21 314 67 48 raphael.heinzer@chuv.ch | |
| Contact: Adam Ogna, MD +41 21 314 67 48 adam.ogna@chuv.ch | |
| Principal Investigator: Adam Ogna, MD | |
| Principal Investigator: Valentina Forni Ogna, MD | |
| Principal Investigator: Raphaël Heinzer, MD | |
| Principal Investigator: | 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) |
| Responsible Party: | Adam Ogna, Centre d'Investigation et Recherche sur le Sommeil (CIRS), Centre Hospitalier Universitaire Vaudois |
| ClinicalTrials.gov Identifier: | NCT02020642 History of Changes |
| Other Study ID Numbers: |
CIRS-SASinTx |
| First Posted: | December 25, 2013 Key Record Dates |
| Last Update Posted: | February 2, 2017 |
| Last Verified: | February 2017 |
Keywords provided by Adam Ogna, Centre Hospitalier Universitaire Vaudois:
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Kidney Diseases Kidney Failure, Chronic Renal Insufficiency, Chronic Renal Insufficiency polysomnography bioimpedance leg fluid shift |
neck circumference Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Disorders Apnea Dyssomnias |
Additional relevant MeSH terms:
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Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Kidney Diseases Kidney Failure, Chronic Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory |
Signs and Symptoms Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases Urologic Diseases Renal Insufficiency, Chronic Renal Insufficiency |