Clinical trial NCT02503215: Effects of Compression Stockings on Obstructive Sleep Apnea in Patients Under Hemodialysis
Official title: Effects of Compression Stockings on Obstructive Sleep Apnea and Autonomic Nervous System in Patients Under Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Failure Chronic Requiring Dialysis
Obstructive Sleep Apnea
Keywords: Hemodialysis
Obstructive sleep apnea
Compression stockings
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2015-07-20
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change of Obstructive Apnea Severity Index Score From Baseline
timeFrame: 1 week
Secondary outcomes:
measure: Change of Heart Rate Variability Change From Baseline
timeFrame: 1 week
measure: Change in Fluid Distribution From Baseline
timeFrame: 1 week
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital das Clínicas 05302050
Study officials:
affiliation: University of Sao Paulo
name: Bruno C Silva, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.