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

Primary Purpose

Renal Failure Chronic Requiring Dialysis, Obstructive Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Compression Stockings
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Failure Chronic Requiring Dialysis focused on measuring Hemodialysis, Obstructive sleep apnea, Compression stockings

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients under hemodialysis
  • Patients with diagnosed obstructive sleep apnea

Exclusion Criteria:

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

Sites / Locations

  • Hospital das Clínicas 05302050

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Compression Stockings

Arm Description

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

Outcomes

Primary Outcome Measures

Change of Obstructive Apnea Severity Index Score From Baseline
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

Change of Heart Rate Variability Change From Baseline
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.
Change in Fluid Distribution From Baseline
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.

Full Information

First Posted
December 26, 2014
Last Updated
May 27, 2016
Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT02503215
Brief Title
Effects of Compression Stockings on Obstructive Sleep Apnea in Patients Under Hemodialysis
Acronym
EComStockOSA
Official Title
Effects of Compression Stockings on Obstructive Sleep Apnea and Autonomic Nervous System in Patients Under Hemodialysis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Failure Chronic Requiring Dialysis, Obstructive Sleep Apnea
Keywords
Hemodialysis, Obstructive sleep apnea, Compression stockings

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Compression Stockings
Arm Type
Experimental
Arm Description
Patients will wear graduated lower limb compression stockings for a week. The investigators will evaluate if such procedure will cause better sleep performance
Intervention Type
Device
Intervention Name(s)
Compression Stockings
Intervention Description
To evaluate the effects of compression stockings on fluid shift and sleep apnea in hemodialysis patients with obstructive sleep apnea
Primary Outcome Measure Information:
Title
Change of Obstructive Apnea Severity Index Score From Baseline
Description
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
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Change of Heart Rate Variability Change From Baseline
Description
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.
Time Frame
1 week
Title
Change in Fluid Distribution From Baseline
Description
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.
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients under hemodialysis Patients with diagnosed obstructive sleep apnea Exclusion Criteria: Congestive heart failure Urine output > 500 ml/day non-sinusal cardiac rhythm refusal to give written consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno C Silva, MD
Organizational Affiliation
University of São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital das Clínicas 05302050
City
São Paulo
ZIP/Postal Code
05403-000
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
23136217
Citation
Elias RM, Chan CT, Paul N, Motwani SS, Kasai T, Gabriel JM, Spiller N, Bradley TD. Relationship of pharyngeal water content and jugular volume with severity of obstructive sleep apnea in renal failure. Nephrol Dial Transplant. 2013 Apr;28(4):937-44. doi: 10.1093/ndt/gfs473. Epub 2012 Nov 7.
Results Reference
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PubMed Identifier
25317087
Citation
Kasai T, Motwani SS, Elias RM, Gabriel JM, Taranto Montemurro L, Yanagisawa N, Spiller N, Paul N, Bradley TD. Influence of rostral fluid shift on upper airway size and mucosal water content. J Clin Sleep Med. 2014 Oct 15;10(10):1069-74. doi: 10.5664/jcsm.4102.
Results Reference
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PubMed Identifier
25620198
Citation
White LH, Lyons OD, Yadollahi A, Ryan CM, Bradley TD. Effect of below-the-knee compression stockings on severity of obstructive sleep apnea. Sleep Med. 2015 Feb;16(2):258-64. doi: 10.1016/j.sleep.2014.12.005. Epub 2014 Dec 18.
Results Reference
background
PubMed Identifier
21836140
Citation
Redolfi S, Arnulf I, Pottier M, Lajou J, Koskas I, Bradley TD, Similowski T. Attenuation of obstructive sleep apnea by compression stockings in subjects with venous insufficiency. Am J Respir Crit Care Med. 2011 Nov 1;184(9):1062-6. doi: 10.1164/rccm.201102-0350OC.
Results Reference
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Effects of Compression Stockings on Obstructive Sleep Apnea in Patients Under Hemodialysis

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