Clinical trial NCT01860209: Effect of Intermittent Hemodialysis on Sleep Apnea Syndrome in End Stage Renal Disease Patients
Official title: Effect of Intermittent Hemodialysis on Sleep Apnea Syndrome 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
Keywords: obstructive sleep apnea
overhydration
end stage renal disease
intermittent ambulatory hemodialysis
polysomnography
bioimpedance
leg fluid shift
neck circumference
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2013-05-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

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

Primary outcomes:
measure: Reduction of the obstructive sleep apnea severity
timeFrame: two nights (before and after an ambulatory hemodialysis session)
Secondary outcomes:
measure: Reduction in nocturnal leg fluid volume shift between the legs and the neck
timeFrame: two nights (before and after an ambulatory hemodialysis session)
measure: relationship between overhydration, leg fluid volume shift, ankle and neck circumference and the severity of obstructive sleep apnea syndrome
timeFrame: one night
measure: severity of the periodic limb movement disorder (PLMD)
timeFrame: two nights (before and after one hemodialysis session)
measure: severity of central sleep apnea syndrome
timeFrame: two nights (before and after one hemodialysis session)
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), Lausanne, Switzerland
name: Raphael Heinzer, MD
role: PRINCIPAL_INVESTIGATOR
References: