Clinical trial NCT02073344: Effect of Beginning a Renal Replacement Therapy on Obstructive Sleep Apnea in End Stage Renal Disease Patients
Official title: Prospective Interventional Study Investigating the Effect of Beginning a Renal Replacement Therapy on Obstructive Sleep Apnea and Its Correlation With Overhydration, in End Stage Renal Disease Patients
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Obstructive Sleep Apnea
End Stage Renal Disease
Keywords: obstructive sleep apnea
overhydration
end stage renal disease
renal transplantation
polysomnography
bioimpedance
leg fluid shift
neck circumference
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2014-02-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: obstructive sleep apnea severity
timeFrame: six months (before and after beginning of a renal replacement therapy)
Secondary outcomes:
measure: nocturnal leg fluid volume shift
timeFrame: six months (before and after beginning of a renal replacement therapy)
measure: relationship between overhydration, leg fluid volume shift, ankle and neck circumference and the severity of obstructive sleep apnea
timeFrame: one night
measure: periodic limb movement disorder (PLMD)
timeFrame: six months (before and after beginning of a renal replacement therapy)
measure: severity of central sleep apnea syndrome
timeFrame: six months (before and after renal beginning of a renal replacement therapy)
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)
name: Raphaël Heinzer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre d'Investigation et Recherche sur le Sommeil (CIRS) - Centre Hospitalier Universitaire Vaudois (CHUV)
name: Adam Ogna, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre d'Investigation et Recherche sur le Sommeil (CIRS) - Centre Hospitalier Universitaire Vaudois (CHUV)
name: Valentina Forni Ogna, MD
role: PRINCIPAL_INVESTIGATOR
References: