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

• Sponsor: University of Sao Paulo (Other)
• Overall Status: Completed
• CT.gov ID: NCT02503215
• Collaborator: Fundação de Amparo à Pesquisa do Estado de São Paulo (Other)
• Enrollment: 14
• Location: 1
• Arm: 1
• Duration (Months): 19
• Patients Per Site Per Month: 0.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Renal Failure Chronic Requiring Dialysis; Obstructive Sleep Apnea	Device: Compression Stockings	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 14 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effects of Compression Stockings on Obstructive Sleep Apnea and Autonomic Nervous System in Patients Under Hemodialysis
• Study Start Date: Aug 1, 2014
• Actual Primary Completion Date: Dec 1, 2015
• Actual Study Completion Date: Mar 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Device: Compression Stockings; To evaluate the effects of compression stockings on fluid shift and sleep apnea in hemodialysis patients with obstructive sleep apnea

Outcome Measures

Primary Outcome Measures

1. Change of Obstructive Apnea Severity Index Score From Baseline [1 week]

   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

1. Change of Heart Rate Variability Change From Baseline [1 week]

   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.

2. Change in Fluid Distribution From Baseline [1 week]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital das Clínicas 05302050	São Paulo		Brazil	05403-000

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Bruno C Silva, MD, University of São Paulo

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• 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.

• Responsible Party: Bruno Caldin da Silva, MD, University of Sao Paulo
• ClinicalTrials.gov Identifier: NCT02503215
• Other Study ID Numbers: 21833413.0.0000.0068
• First Posted: Jul 20, 2015
• Last Update Posted: Jul 7, 2016
• Last Verified: May 1, 2016

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Bruno Caldin da Silva, MD, University of Sao Paulo: Hemodialysis; Obstructive sleep apnea; Compression stockings
• Additional relevant MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Kidney Failure, Chronic

Study Results

Participant Flow

Recruitment Details	Patients were screened for sleep apnea from August to October 2014. Screening consisted of applying the Berlin Questionnaire. Patients at risk for sleep-disordered breathing were then submitted to polysomnography in order to confirm obstructive sleep apnea. Patients with apnea/hypopnea index > 5 were recruited.
Pre-assignment Detail	Patients who did not have obstructive sleep apnea at the initial polysomnography evaluation were excluded from study. Additionally, patients who were unable to wear compression stockings or use positive airway pressure after enrollment were also excluded from study

Arm/Group Title	Compression Stockings
Arm/Group Description	Patients wore graduated lower limb compression stockings for a week. The investigators evaluated if such procedure caused better sleep performance Compression Stockings: To evaluate the effects of compression stockings on fluid shift and sleep apnea in hemodialysis patients with obstructive sleep apnea
Period Title: Overall Study
STARTED	17
COMPLETED	14
NOT COMPLETED	3

Baseline Characteristics

Arm/Group Title	Compression Stockings
Arm/Group Description	Patients wore graduated lower limb compression stockings for a week. The investigators evaluated if such procedure caused better sleep performance Compression Stockings: To evaluate the effects of compression stockings on fluid shift and sleep apnea in hemodialysis patients with obstructive sleep apnea
Overall Participants	14
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	13 92.9%
>=65 years	1 7.1%
Sex: Female, Male (Count of Participants)
Female	6 42.9%
Male	8 57.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	11 78.6%
Not Hispanic or Latino	3 21.4%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	1 7.1%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	1 7.1%
White	2 14.3%
More than one race	10 71.4%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
Brazil	14 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Apnea/Hypopnea Index

Arm/Group Title	Compression Stockings
Arm/Group Description	Patients wore graduated lower limb compression stockings for a week. The investigators evaluated if such procedure caused better sleep performance Compression Stockings: To evaluate the effects of compression stockings on fluid shift and sleep apnea in hemodialysis patients with obstructive sleep apnea
Measure Participants	14
Baseline	20.8
Compression Stockings	16.7

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Overnight increase in LF/HF ratio at baseline: 11/12 patients (92%) Overnight increase in LF/HF ratio after compression stockings use: 7/12 patients (58%)

Arm/Group Title	Compression Stockings
Arm/Group Description	Patients wore graduated lower limb compression stockings for a week. The investigators evaluated if such procedure caused better sleep performance Compression Stockings: To evaluate the effects of compression stockings on fluid shift and sleep apnea in hemodialysis patients with obstructive sleep apnea
Measure Participants	12
Baseline	92 657.1%
Compression Stockings	58 414.3%

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Volume distribution evaluated by bioimpedance analysis evaluated fluid shift from the legs at baseline and after wearing compression stockings. The amount overnight fluid that moved rostrally from the legs is depicted below (results expressed as mean ± standard deviation): Baseline: 571.4 ± 389.6 ml Compression stockings: 517.9 ± 452.2 ml

Arm/Group Title	Compression Stockings
Arm/Group Description	Patients wore graduated lower limb compression stockings for a week. The investigators evaluated if such procedure caused better sleep performance Compression Stockings: To evaluate the effects of compression stockings on fluid shift and sleep apnea in hemodialysis patients with obstructive sleep apnea
Measure Participants	14
Baseline	571.4 (389.6)
Compression Stockings	517.9 (452.2)

Adverse Events

Time Frame	Data regarding adverse events were collected during the one-week period while patients wore the compression stockings. Events assessed: dyspnea, and lower limbs pain.
Arm/Group Title	Compression Stockings
Arm/Group Description	Patients wore graduated lower limb compression stockings for a week. The investigators evaluated if such procedure caused better sleep performance Compression Stockings: To evaluate the effects of compression stockings on fluid shift and sleep apnea in hemodialysis patients with obstructive sleep apnea
All Cause Mortality
	Compression Stockings
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Compression Stockings
	Affected / at Risk (%)	# Events
Total	0/14 (0%)
Other (Not Including Serious) Adverse Events
	Compression Stockings
	Affected / at Risk (%)	# Events
Total	0/14 (0%)

Limitations/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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.