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

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

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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea; End Stage Renal Disease; Renal Transplantation; Overhydration
• Intervention / Treatment: Procedure: Renal transplantation

Detailed Description

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
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Vaud
    • Lausanne, Vaud, Switzerland, 1011
      • Centre d'Investigation et Recherche sur le Sommeil (CIRS) - Centre Hospitalier Universitaire Vaudois (CHUV)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Procedure: Renal transplantation; Renal transplantation from cadaveric or live donor
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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Vaudois
• Investigators: Principal Investigator: Rapahël Heinzer, 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)

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (ACTUAL): December 1, 2017
• Study Completion (ACTUAL): December 1, 2017

Study Registration Dates

• First Submitted: December 19, 2013
• First Submitted That Met QC Criteria: December 19, 2013
• First Posted (ESTIMATE): December 25, 2013

Study Record Updates

• Last Update Posted (ACTUAL): August 15, 2018
• Last Update Submitted That Met QC Criteria: August 13, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: polysomnography; Sleep Apnea, Obstructive; Kidney Failure, Chronic; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Sleep Disorders; Sleep Apnea Syndromes; Sleep Disorders, Intrinsic; Apnea; bioimpedance; leg fluid shift; neck circumference; Dyssomnias
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Urologic Diseases; Renal Insufficiency; Signs and Symptoms, Respiratory; Renal Insufficiency, Chronic; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Kidney Diseases; Apnea; Kidney Failure, Chronic
• Other Study ID Numbers: CIRS-SASinTx