Effects of Compression Stockings on Obstructive Sleep Apnea in Patients Under Hemodialysis

Not Applicable

Completed

• Conditions: Renal Failure Chronic Requiring Dialysis; Obstructive Sleep Apnea
• Interventions: Device: Compression Stockings

• Registration Number: NCT02503215
• Lead Sponsor: University of Sao Paulo

Brief Summary

To study the effects of compression stockings on sleep apnea in hemodialysis patients with diagnosed obstructive sleep apnea. The rationale of this study consists in the fluid shift theory, which consists in the nocturnal rostral fluid shift from legs, which causes upper airways edema.

The aim of this study is to evaluate if compression stockings could improve such nocturnal volume redistribution and, therefore, improve obstructive sleep apnea.

Detailed Description

Investigators will apply the following methods:

* Sleep study, performed through polysomnography

* Fluid redistribution, by bioimpedance analysis

* Autonomic nervous system evaluation, by spectral heart rate variability analysis.

The study protocol comprises two moments: baseline evaluation (in patients with diagnosed sleep apnea) and after using compression stockings for a one-week period.

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-12-26
• Study First Submitted QC: 2015-07-16
• Study First Posted: 2015-07-20
• Primary Completion: 2015-12
• Study Completion: 2016-03
• Results First Submitted: 2016-03-21
• Status Verified: 2016-05
• Results First Submitted QC: 2016-05-27
• Last Update Submitted: 2016-05-27
• Results First Posted: 2016-07-07
• Last Update Posted: 2016-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• Patients under hemodialysis
• Patients with diagnosed obstructive sleep apnea

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Exclusion Criteria

• Congestive heart failure
• Urine output > 500 ml/day
• non-sinusal cardiac rhythm
• refusal to give written consent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Compression Stockings	Compression Stockings	Patients will wear graduated lower limb compression stockings for a week. The investigators will evaluate if such procedure will cause better sleep performance

Primary Outcome Measures

Name	Time	Method
Change of Obstructive Apnea Severity Index Score From Baseline	1 week	Apnea/Hypopnea index (AIH) was assessed by a validated polysomnography (EMBLA®S4500, Embla Systems Inc., Broomfield, CO, USA) at baseline and 1 week after compression stockings use. The observed results are expressed as median and interquartile range (25,75 percentiles): * AIH at baseline: 20.8 (14.2; 39.6) events/hour; * AIH after compression stockings use: 16.7 (3.5; 28.9) events/hour

Secondary Outcome Measures

Name	Time	Method
Change in Fluid Distribution From Baseline	1 week	Segmental and total body water will be non-invasively assessed before sleeping and after awakening by a bioimpedance device (InBody S10 Analyser™, Biospace, South Korea), which will provide information regarding nighttime fluid shift at baseline and after compression stocking use. The amount of water, expressed in liters, is assessed in both extra and intracellular components.
Change of Heart Rate Variability Change From Baseline	1 week	Electrocardiogram performed during polysomnography examination will be downloaded to a specific software for heart rate variability assessment (Kubius HRV™, University of Eastern Finland, Finland), which provides spectral assessment of heart rate variability in its both components: low frequency (LF) and high frequency (HF). Patients who present higher LF/HF during the night compared to the beggining of the polysomnography exam have, by definition, increased sympathetic activity during the night. Such evaluation will be accessed in both baseline and after compression stockings use.

Trial Locations

Locations (1)

Hospital das Clínicas 05302050; 🇧🇷 São Paulo, Brazil