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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT02073344
Other study ID # CIRS-SASinHD_005
Secondary ID
Status Suspended
Phase N/A
First received
Last updated
Start date March 2014
Est. completion date November 2022

Study information

Verified date August 2020
Source Centre Hospitalier Universitaire Vaudois
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Suspended
Enrollment 30
Est. completion date November 2022
Est. primary completion date November 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Procedure:
Renal replacement therapy
intermittent hemodialysis or peritoneal dialysis
Other:
no intervention
no renal replacement therapy

Locations

Country Name City State
Switzerland Centre d'Investigation et Recherche sur le Sommeil (CIRS) - Centre Hospitalier Universitaire Vaudois (CHUV) Lausanne Vaud

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire Vaudois

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary obstructive sleep apnea severity Reduction of the obstructive sleep apnea severity, measured by attended polysomnography, six months after beginning of a renal replacement therapy six months (before and after beginning of a renal replacement therapy)
Secondary nocturnal leg fluid volume shift 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 six months (before and after beginning of a renal replacement therapy)
Secondary relationship between overhydration, leg fluid volume shift, ankle and neck circumference and the severity of obstructive sleep apnea one night
Secondary periodic limb movement disorder (PLMD) six months (before and after beginning of a renal replacement therapy)
Secondary severity of central sleep apnea syndrome six months (before and after renal beginning of a renal replacement therapy)
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