An interventional study of Compression Stockings in Renal Failure Chronic Requiring Dialysis and Obstructive Sleep Apnea, sponsored by University of Sao Paulo. Completed at 1 site in Brazil. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-07-07.
Sponsored by University of Sao Paulo · Not applicable, Interventional, and Treatment
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.
Investigators will apply the following methods:
The study protocol comprises two moments: baseline evaluation (in patients with diagnosed sleep apnea) and after using compression stockings for a one-week period.
2,263 studies on the registry are indexed under Sleep Apnea, Obstructive; 465 are open to participants now.
This study's enrollment of 14 is below the median of 53 across 1,490 interventional studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →University of Sao Paulo is the lead sponsor of 1,030 studies on the registry; 92 are open to participants now.
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Exclusion Criteria:
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
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
Time frame: 1 week
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.
Time frame: 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.
Time frame: 1 week
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.
| Milestone | Compression Stockings |
|---|---|
| Started | 17 |
| Completed | 14 |
| Not completed | 3 |
| Withdrew: Unable to wear compression stockings | 1 |
| Withdrew: Unable to use positive airway pressure | 2 |
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
| events/hour | Compression Stockings |
|---|---|
| Baseline | 20.8 (14.2 to 39.6) |
| Compression Stockings | 16.7 (3.5 to 28.9) |
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.
| percentage of participants | Compression Stockings |
|---|---|
| Baseline | 92 |
| Compression Stockings | 58 |
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.
| mililiters | Compression Stockings |
|---|---|
| Baseline | 571.4 ± 389.6 |
| Compression Stockings | 517.9 ± 452.2 |
Collected over Data regarding adverse events were collected during the one-week period while patients wore the compression stockings. Events assessed: dyspnea, and lower limbs pain.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Compression Stockings | — | 0/14 (0%) | 0/14 (0%) |
| Age, Categorical(Participants) | Compression Stockings |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 13 |
| >=65 years | 1 |
| Sex: Female, Male(Participants) | Compression Stockings |
|---|---|
| Female | 6 |
| Male | 8 |
| Ethnicity (NIH/OMB)(Participants) | Compression Stockings |
|---|---|
| Hispanic or Latino | 11 |
| Not Hispanic or Latino | 3 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Compression Stockings |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 2 |
| More than one race | 10 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Compression Stockings |
|---|---|
| Brazil | 14 |
Plan to share: Yes
The record gives a start of Aug 2014, a primary completion of Dec 2015 and a completion of Mar 2016. It does not say whether these dates are actual or estimated.
Results were first posted in Jul 2016, 7 months after primary completion.
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This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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