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

Obstructive Sleep Apnea Clinical Trial

— COSTOSA-HD  

Official title:

Effects of Compression Stockings on Obstructive Sleep Apnea and Autonomic Nervous System in Patients Under Hemodialysis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02503215
• Other study ID #: 21833413.0.0000.0068
• Status: Recruiting
• Phase: N/A
• First received: December 26, 2014
• Last updated: July 16, 2015
• Start date: August 2014
• Est. completion date: June 2016

Study information

• Verified date: July 2015
• Source: University of Sao Paulo
• Contact: Bruno C SILVA, MD
• Phone: +5511997620521
• Email: brunocaldin[@]hotmail.com
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: June 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients under hemodialysis

• Patients with diagnosed obstructive sleep apnea

Exclusion Criteria:

• Cardiac disease

• Urine output > 500 ml/day

• non-sinusal cardiac rhythm

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Kidney Failure, Chronic
• Obstructive Sleep Apnea
• Renal Failure Chronic Requiring Dialysis
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• Compression Stockings
To evaluate the effects of compression stockings on fluid shift and sleep apnea in hemodialysis patients with obstructive sleep apnea

Locations

Country	Name	City	State
Brazil	Hospital das Clínicas 05302050	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of obstructive apnea severity index score from baseline	Apnea/Hypopnea index (AIH) will be assessed by a validated polysomnography (EMBLA®S4500, Embla Systems Inc., Broomfield, CO, USA) at baseline and 1 week after compression stockings use.	1 week	No
Secondary	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). The standard relation LF/HF at baseline and after compression stockings use will be analysed.	1 week	No
Secondary	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.	1 week	No