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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01860209
Other study ID # CIRS-SASinHD
Secondary ID
Status Completed
Phase N/A
First received May 18, 2013
Last updated December 19, 2013
Start date March 2013
Est. completion date October 2013

Study information

Verified date December 2013
Source Centre Hospitalier Universitaire Vaudois
Contact n/a
Is FDA regulated No
Health authority Switzerland: Ethikkommission
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date October 2013
Est. primary completion date October 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label


Intervention

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

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 Reduction of the obstructive sleep apnea severity Reduction of the obstructive sleep apnea severity, measured by attended polysomnography, after an ambulatory hemodialysis session two nights (before and after an ambulatory hemodialysis session) No
Secondary Reduction in nocturnal leg fluid volume shift between the legs and the neck Reduction in nocturnal leg fluid volume shift between the legs and the neck, measured by bioimpedance and neck circumference after an ambulatory hemodialysis session two nights (before and after an ambulatory hemodialysis session) No
Secondary relationship between overhydration, leg fluid volume shift, ankle and neck circumference and the severity of obstructive sleep apnea syndrome relationship between overhydration (measured by bioimpedance), leg fluid volume shift, ankle and neck circumference and the severity of obstructive sleep apnea syndrome one night No
Secondary severity of the periodic limb movement disorder (PLMD) severity of the periodic limb movement disorder (PLMD) two nights (before and after one hemodialysis session) No
Secondary severity of central sleep apnea syndrome severity of central sleep apnea syndrome two nights (before and after one hemodialysis session) No
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