Renal Failure Chronic Requiring Dialysis, Obstructive Sleep Apnea
Conditions
Keywords
Hemodialysis, Obstructive sleep apnea, Compression stockings
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.
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.
Interventions
DEVICECompression Stockings
To evaluate the effects of compression stockings on fluid shift and sleep apnea in hemodialysis patients with obstructive sleep apnea
Sponsors
Fundação de Amparo à Pesquisa do Estado de São Paulo
University of Sao Paulo
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
Brazil
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 details
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
Participants by arm
| Arm | Count |
|---|---|
| Compression Stockings 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 | 14 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Unable to use positive airway pressure | 2 |
| Overall Study | Unable to wear compression stockings | 1 |
Baseline characteristics
| Characteristic | Compression Stockings |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 10 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Region of Enrollment Brazil | 14 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 |
Outcome results
Primary
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
Population: Apnea/Hypopnea Index
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Compression Stockings | Change of Obstructive Apnea Severity Index Score From Baseline | Baseline | 20.8 events/hour |
| Compression Stockings | Change of Obstructive Apnea Severity Index Score From Baseline | Compression Stockings | 16.7 events/hour |
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.
Time frame: 1 week
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Compression Stockings | Change in Fluid Distribution From Baseline | Baseline | 571.4 mililiters | Standard Deviation 389.6 |
| Compression Stockings | Change in Fluid Distribution From Baseline | Compression Stockings | 517.9 mililiters | Standard Deviation 452.2 |
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). 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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Compression Stockings | Change of Heart Rate Variability Change From Baseline | Baseline | 92 percentage of participants |
| Compression Stockings | Change of Heart Rate Variability Change From Baseline | Compression Stockings | 58 percentage of participants |