Effect of Beginning a Renal Replacement Therapy on Obstructive Sleep Apnea in End Stage Renal Disease Patients

Not Applicable

Suspended

• Conditions: Obstructive Sleep Apnea; End Stage Renal Disease
• Interventions: Procedure: Renal replacement therapy; Other: no intervention

• Registration Number: NCT02073344
• Lead Sponsor: Centre Hospitalier Universitaire Vaudois

Brief Summary

The purpose of this study is to investigate the effect of beginning a renal replacement therapy 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

The prevalence of obstructive sleep apnea increases with progressing renal insufficiency. Recent observations suggest a causative relationship between overnight fluid displacement from the legs to the neck soft tissues and the severity of obstructive sleep apnea. We suspect that this pathophysiologic mechanism could explain the increased prevalence of obstructive sleep apnea in patients with fluid overload, including chronic renal failure.

The beginning of a renal replacement therapy modify the fluid balance of the end stage renal disease patients and could therefore impact on the severity of sleep apnea in this population.

The purpose of this trial is to investigate the hypothesis that the transition from untreated end stage renal disease and a renal replacement therapy decreases the severity of sleep apnea, by a reduction of the fluid overload and of the nocturnal rostral fluid shift.

The severity of obstructive sleep apnea is measured by two attended polysomnographies (PSG), a baseline PSG performed before and a follow-up PSG performed 6 month after beginning of a renal replacement therapy. Overhydration and leg fluid are evaluated by bioimpedance, performed at the beginning and at the end of each polysomnography. Patients who have not yet begun a renal replacement therapy 6 months after the baseline PSG will be re-assessed and will be analyzed as control group

Study Timeline

• Study First Submitted: 2014-02-25
• Study First Submitted QC: 2014-02-25
• Study First Posted: 2014-02-27
• Study Start: 2014-03
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-03
• Last Update Posted: 2020-08-05
• Primary Completion: 2021-11
• Study Completion: 2022-11

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 30

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 without renal replacement therapy.

Exclusion Criteria

• unstable congestive heart failure
• active psychiatric disease
• amputation of the lower limbs, proximal to the ankle

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intevention group	Renal replacement therapy	A baseline polysomnography (PSG) is performed at inclusion, followed by a follow-up PSG 6 months after the beginning of a renal replacement therapy
Control group	no intervention	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 on renal replacement therapy

Primary Outcome Measures

Name	Time	Method
obstructive sleep apnea severity	six months (before and after beginning of a renal replacement therapy)	Reduction of the obstructive sleep apnea severity, measured by attended polysomnography, six months after beginning of a renal replacement therapy

Secondary Outcome Measures

Name	Time	Method
severity of central sleep apnea syndrome	six months (before and after renal beginning of a renal replacement therapy)
nocturnal leg fluid volume shift	six months (before and after beginning of a renal replacement therapy)	Reduction in nocturnal leg fluid volume shift between the legs and the neck, measured by bioimpedance and neck circumference six months after beginning of a renal replacement therapy
periodic limb movement disorder (PLMD)	six months (before and after beginning of a renal replacement therapy)
relationship between overhydration, leg fluid volume shift, ankle and neck circumference and the severity of obstructive sleep apnea	one night

Trial Locations

Locations (1)

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