Clinical trial NCT02020642: Effect of Renal Transplantation on Obstructive Sleep Apnea in End Stage Renal Disease Patients (SASinTx)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Overhydration
End Stage Renal Disease
Renal Transplantation
Keywords: polysomnography
bioimpedance
leg fluid shift
neck circumference
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Sleep Disorders, Intrinsic
Sleep Disorders
Apnea
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Dyssomnias
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2013-12-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Reduction of the obstructive sleep apnea severity
timeFrame: six months after renal transplantation
Secondary outcomes:
measure: Reduction in nocturnal leg fluid volume shift between the legs and the neck
timeFrame: six months after renal transplantation
measure: Relationship between overhydration, leg fluid volume shift, ankle and neck circumference and the severity of obstructive sleep apnea
timeFrame: at baseline and six months after renal transplantation
measure: Change in the severity of the periodic limb movement disorder (PLMD)
timeFrame: six months after renal transplantation
measure: Change in the severity of central sleep apnea
timeFrame: six months after renal transplantation
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Centre d'Investigation et Recherche sur le Sommeil (CIRS) - Centre Hospitalier Universitaire Vaudois (CHUV)
state: Vaud
Study officials:
affiliation: Centre d'Investigation et Recherche sur le Sommeil (CIRS) - Centre Hospitalier Universitaire Vaudois (CHUV)
name: Rapahël Heinzer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre d'Investigation et Recherche sur le Sommeil (CIRS) - Centre Hospitalier Universitaire Vaudois (CHUV)
name: Adam Ogna, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Service de Néphrologie et Hypertension - Centre Hospitalier Universitaire Vaudois (CHUV)
name: Valentina Forni Ogna, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.