Effect of Intermittent Hemodialysis on Sleep Apnea Syndrome in End Stage Renal Disease Patients

Obstructive Sleep Apnea Clinical Trial

— SASinHD  

Official title:

Effect of Intermittent Hemodialysis on Sleep Apnea Syndrome and Its Correlation to Nocturnal Rostral Fluid Shift, in End Stage Renal Disease Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01860209
• Other study ID #: CIRS-SASinHD
• 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

Related Conditions & MeSH terms

• Apnea
• End Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Obstructive Sleep Apnea
• Overhydration
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

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