Effect of Intermittent Hemodialysis on Sleep Apnea Syndrome in End Stage Renal Disease Patients

Not Applicable

Completed

• Conditions: Overhydration; Obstructive Sleep Apnea; End Stage Renal Disease
• Interventions: Procedure: Hemodialysis

• Registration Number: NCT01860209
• Lead Sponsor: Centre Hospitalier Universitaire Vaudois

Brief Summary

The purpose of this study is to investigate the effect of decreasing fluid overload by hemodialysis on the severity of obstructive sleep apnea, in patients with end stage chronic kidney disease on intermittent hemodialysis. 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 hypervolemia, including chronic renal failure.

The purpose of this trial is to investigate the hypothesis that nocturnal rostral fluid ship is linked to overhydration and participates significantly to the severity of obstructive sleep apnea in patients on hemodialysis. The correction of overhydration by hemodialysis should therefore reduce the amount of nocturnally displaced water and consequently lower the severity of obstructive sleep apnea.

The severity of obstructive sleep apnea is measured by two consecutive attended polysomnographies, performed before and after an ambulatory hemodialysis session with fluid removal, whereas overhydration and leg fluid are evaluated by bioimpedance, performed at the beginning and at the end of each polysomnography. The sequence of the two polysomnographies with respect to hemodialysis is randomized, to minimize the first-night effect.

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-05-18
• Study First Submitted QC: 2013-05-18
• Study First Posted: 2013-05-22
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-19
• Last Update Posted: 2013-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• moderate to severe obstructive sleep apnea syndrome, with an apnea-hypopnea index (AHI) ≥ 15/h
• age ≥ 18 years
• patient with end stage renal disease on chronic intermittent hemodialysis

Exclusion criteria:

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Hemodialysis	the first polysomnography (PSG) is performed before hemodialysis (HD), followed by a post-HD PSG on the subsequent night
Group B	Hemodialysis	the first PSG is performed after hemodialysis (HD), followed by a pre-HD PSG, on the subsequent night

Primary Outcome Measures

Name	Time	Method
Reduction of the obstructive sleep apnea severity	two nights (before and after an ambulatory hemodialysis session)	Reduction of the obstructive sleep apnea severity, measured by attended polysomnography, after an ambulatory hemodialysis session

Secondary Outcome Measures

Name	Time	Method
severity of central sleep apnea syndrome	two nights (before and after one hemodialysis session)	severity of central sleep apnea syndrome
relationship between overhydration, leg fluid volume shift, ankle and neck circumference and the severity of obstructive sleep apnea syndrome	one night	relationship between overhydration (measured by bioimpedance), leg fluid volume shift, ankle and neck circumference and the severity of obstructive sleep apnea syndrome
Reduction in nocturnal leg fluid volume shift between the legs and the neck	two nights (before and after an ambulatory hemodialysis session)	Reduction in nocturnal leg fluid volume shift between the legs and the neck, measured by bioimpedance and neck circumference after an ambulatory hemodialysis session
severity of the periodic limb movement disorder (PLMD)	two nights (before and after one hemodialysis session)	severity of the periodic limb movement disorder (PLMD)

Trial Locations

Locations (1)

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