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

NCT02503215 | Completed Results

• 1 other identifier: 21833413.0.0000.0068
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Failure Chronic Requiring Dialysis; Obstructive Sleep Apnea

Keywords

Hemodialysis; Obstructive sleep apnea; Compression stockings

Outcome Measures

Primary Outcomes (1)

• 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

  1 week

Secondary Outcomes (2)

• Change of Heart Rate Variability Change From Baseline

  1 week

• Change in Fluid Distribution From Baseline

  1 week

Study Arms (1)

Compression Stockings

EXPERIMENTAL

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

Device: Compression Stockings

Interventions

Compression Stockings DEVICE

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

Compression Stockings

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients under hemodialysis
• Patients with diagnosed obstructive sleep apnea

You may not qualify if:

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

Sponsors & Collaborators

• University of Sao Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Hospital das Clínicas 05302050

São Paulo, São Paulo, 05403-000, Brazil

Location

Related 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.

  PMID: 23136217 BACKGROUND

• 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.

  PMID: 25317087 BACKGROUND

• 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.

  PMID: 25620198 BACKGROUND

• 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.

  PMID: 21836140 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Stockings, Compression

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Compression Bandages; Bandages; Equipment and Supplies

Limitations and Caveats

During heart rate variability analysis, two patients had techinical problems during electrocardiogram aquisition and could not habe their data analysed and were therefore excluded from final results.

Results Point of Contact

• Title: Dr Bruno Caldin da Silva
• Organization: Nephrology Division, University of São Paulo

brunocaldin@hotmail.com

5511997620521

Study Officials

• Bruno C Silva, MD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 26, 2014
• First Posted: July 20, 2015
• Study Start: August 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: March 1, 2016
• Last Updated: July 7, 2016
• Results First Posted: July 7, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will share

Locations

BR (1)