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

NCT ID: NCT02503215

Last Updated: 2016-07-07

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2016-03-31

Brief Summary

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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

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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.

Conditions

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Renal Failure Chronic Requiring Dialysis Obstructive Sleep Apnea

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Compression Stockings

Intervention Type DEVICE

To evaluate the effects of compression stockings on fluid shift and sleep apnea in hemodialysis patients with obstructive sleep apnea

Interventions

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Compression Stockings

To evaluate the effects of compression stockings on fluid shift and sleep apnea in hemodialysis patients with obstructive sleep apnea

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Bruno Caldin da Silva

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bruno C Silva, MD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

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Hospital das Clínicas 05302050

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type BACKGROUND
PMID: 23136217 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25317087 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25620198 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21836140 (View on PubMed)

Other Identifiers

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21833413.0.0000.0068

Identifier Type: -

Identifier Source: org_study_id

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