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

NCT ID: NCT01860209

Last Updated: 2013-12-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2013-10-31

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.

Conditions

Obstructive Sleep Apnea; Overhydration; End Stage Renal Disease

Keywords

obstructive sleep apnea; overhydration; end stage renal disease; intermittent ambulatory hemodialysis; polysomnography; bioimpedance; leg fluid shift; neck circumference

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

Group A

the first polysomnography (PSG) is performed before hemodialysis (HD), followed by a post-HD PSG on the subsequent night

Group Type: EXPERIMENTAL

Hemodialysis

Intervention Type: PROCEDURE

Intermittent ambulatory hemodialysis session, according to the patient usual protocol (defined by the treating nephrologist independently of the study)

Group B

the first PSG is performed after hemodialysis (HD), followed by a pre-HD PSG, on the subsequent night

Group Type: EXPERIMENTAL

Hemodialysis

Intervention Type: PROCEDURE

Intermittent ambulatory hemodialysis session, according to the patient usual protocol (defined by the treating nephrologist independently of the study)

Interventions

Hemodialysis

Intermittent ambulatory hemodialysis session, according to the patient usual protocol (defined by the treating nephrologist independently of the study)

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire Vaudois

OTHER

Sponsor Role: lead

Responsible Party

Adam Ogna

Centre d'Investigation et Recherche sur le Sommeil (CIRS)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Raphael Heinzer, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Centre d'Investigation et Recherche sur le Sommeil (CIRS) - Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, Canton of Vaud, Switzerland

Countries

Switzerland

Other Identifiers

CIRS-SASinHD

Identifier Type: -

Identifier Source: org_study_id