Trial Outcomes & Findings for Effects of Compression Stockings on Obstructive Sleep Apnea in Patients Under Hemodialysis (NCT NCT02503215)

Last Updated: 2016-07-07

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

14 participants

Primary outcome timeframe

1 week

Results posted on

2016-07-07

Participant Flow

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.

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

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	17
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	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
Overall Study Unable to wear compression stockings	1
Overall Study Unable to use positive airway pressure	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Compression Stockings n=14 Participants 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	10 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Brazil	14 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 week

Population: Apnea/Hypopnea Index

Outcome measures

Outcome measures
Measure	Compression Stockings n=14 Participants 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
Change of Obstructive Apnea Severity Index Score From Baseline Baseline	20.8 events/hour Interval 14.2 to 39.6
Change of Obstructive Apnea Severity Index Score From Baseline Compression Stockings	16.7 events/hour Interval 3.5 to 28.9

SECONDARY outcome

Timeframe: 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%)

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.

Outcome measures

Outcome measures
Measure	Compression Stockings n=12 Participants 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
Change of Heart Rate Variability Change From Baseline Baseline	92 percentage of participants
Change of Heart Rate Variability Change From Baseline Compression Stockings	58 percentage of participants

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	Compression Stockings n=14 Participants 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
Change in Fluid Distribution From Baseline Baseline	571.4 mililiters Standard Deviation 389.6
Change in Fluid Distribution From Baseline Compression Stockings	517.9 mililiters Standard Deviation 452.2

Adverse Events

Compression Stockings

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Bruno Caldin da Silva

Nephrology Division, University of São Paulo

Phone: 5511997620521

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place