Effect of Beginning a Renal Replacement Therapy on Obstructive Sleep Apnea in End Stage Renal Disease Patients

Obstructive Sleep Apnea Clinical Trial

— SASinHD_005  

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02073344
• Other study ID #: CIRS-SASinHD_005
• Status: Suspended
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

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

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)