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

Obstructive Sleep Apnea Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02020642
• Other study ID #: CIRS-SASinTx
• Status: Completed
• Phase: N/A
• Start date: October 2013
• Est. completion date: December 2017

Study information

• Verified date: August 2018
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• End Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Obstructive Sleep Apnea
• Overhydration
• Renal Transplantation
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Procedure:
• Renal transplantation
Renal transplantation from cadaveric or live donor

Locations

Country	Name	City	State
Switzerland	Centre d'Investigation et Recherche sur le Sommeil (CIRS) - Centre Hospitalier Universitaire Vaudois (CHUV)	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Vaudois

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Change in the severity of central sleep apnea	Change in the severity of central sleep apnea	six months after renal transplantation