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

U

University of Sao Paulo

Status

Completed

Conditions

Obstructive Sleep Apnea
Renal Failure Chronic Requiring Dialysis

Treatments

Device: Compression Stockings

Study type

Interventional

Funder types

Other

Identifiers

NCT02503215
21833413.0.0000.0068

Details and patient eligibility

About

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.

Full 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.

Enrollment

14 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

14 participants in 1 patient group

Compression Stockings
Experimental group
Description:
Patients will wear graduated lower limb compression stockings for a week. The investigators will evaluate if such procedure will cause better sleep performance
Treatment:
Device: Compression Stockings

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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