Renal Failure Chronic Requiring DialysisEComStockOSANCT02503215
Effects of Compression Stockings on Obstructive Sleep Apnea in Patients Under Hemodialysis
A study testing Compression Stockings in people with Renal Failure Chronic Requiring Dialysis and Obstructive Sleep Apnea, run by University of Sao Paulo at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Renal Failure Chronic Requiring Dialysis, Obstructive Sleep Apnea
- What is being tested?
- Compression Stockings
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2014to Mar 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients under hemodialysis
- Patients with diagnosed obstructive sleep apnea
Who cannot join
- Congestive heart failure
- Urine output > 500 ml/day
- non-sinusal cardiac rhythm
- refusal to give written consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Compression Stockings on Obstructive Sleep Apnea and Autonomic Nervous System in Patients Under Hemodialysis
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.
Read the 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.
- Being tested
- Compression Stockings
- Keywords
- Hemodialysis, Obstructive sleep apnea, Compression stockings
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compression StockingsDevice
To evaluate the effects of compression stockings on fluid shift and sleep apnea in hemodialysis patients with obstructive sleep apnea
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Compression Stockings |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 week
Secondary outcomes (2)
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). 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.
Measured: 1 week
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.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2015 (estimated)
- Study startAug 2014
- Primary completionDec 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Renal Failure Chronic Requiring DialysisStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Bruno Caldin da Silva, University of Sao Paulo
- Investigators
- Bruno C Silva, MD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02503215
- Sponsor's protocol ID
- 21833413.0.0000.0068
- Acronym
- EComStockOSA
- Status last verified
- May 2016
- First submitted
- 26 Dec 2014
- Last updated
- 7 Jul 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes
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.
PubMed 23136217Kasai 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.
PubMed 25317087White 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.
PubMed 25620198Redolfi 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.
PubMed 21836140
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Compression Stockings on Obstructive Sleep Apnea and Autonomic Nervous System in Patients Under Hemodialysis
- ClinicalTrials.gov ID
- NCT02503215
- Acronym / sponsor ID
- EComStockOSA / 21833413.0.0000.0068
- Keywords
- Hemodialysis, Obstructive sleep apnea, Compression stockings
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Aug 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 20 Jul 2015 (estimated)
- Results
- Posted 7 Jul 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Compression Stockings | Experimental | Device: Compression StockingsPatients will wear graduated lower limb compression stockings for a week. The investigators will evaluate if such procedure will cause better sleep performance |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients under hemodialysis
- Patients with diagnosed obstructive sleep apnea
Key exclusion criteria (4 listed)
- Congestive heart failure
- Urine output > 500 ml/day
- non-sinusal cardiac rhythm
- refusal to give written consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compression StockingsTo evaluate the effects of compression stockings on fluid shift and sleep apnea in hemodialysis patients with obstructive sleep apnea | Device | Compression Stockings |
Primary outcome
Change of Obstructive Apnea Severity Index Score From Baseline
Time frame: 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
2 secondary outcomes
Change of Heart Rate Variability Change From Baseline
Time frame: 1 week
Change in Fluid Distribution From Baseline
Time frame: 1 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23136217Elias 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.
- Background: PubMed 25317087Kasai 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.
- Background: PubMed 25620198White 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.
- Background: PubMed 21836140Redolfi 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruno C Silva, MD principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compression Stockings in people with Renal Failure Chronic Requiring Dialysis and Obstructive Sleep Apnea, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Obstructive Apnea Severity Index Score From Baseline (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02503215, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2016.