End Stage Renal Disease, Obstructive Sleep Apnea
Conditions
Keywords
obstructive sleep apnea, overhydration, end stage renal disease, renal transplantation, polysomnography, bioimpedance, leg fluid shift, neck circumference
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
Interventions
PROCEDURERenal replacement therapy
intermittent hemodialysis or peritoneal dialysis
OTHERno intervention
no renal replacement therapy
Sponsors
Centre Hospitalier Universitaire Vaudois
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| relationship between overhydration, leg fluid volume shift, ankle and neck circumference and the severity of obstructive sleep apnea | one night | — |
| periodic limb movement disorder (PLMD) | six months (before and after beginning of a renal replacement therapy) | — |
| severity of central sleep apnea syndrome | six months (before and after renal beginning of a renal replacement therapy) | — |
Countries
Switzerland
Outcome results
None listed