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Clinical Trials/NCT02420184
NCT02420184
Completed
Not Applicable

Treatment of Obstructive Sleep Apnea in Chronic Kidney Disease

University of Calgary0 sites57 target enrollmentJune 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sleep Apnea, Obstructive
Sponsor
University of Calgary
Enrollment
57
Primary Endpoint
eGFR (estimated glomerular filtration rate)
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

This study is being conducted to determine whether treatment of obstructive sleep apnea (OSA) in patients with chronic kidney disease (CKD) improves kidney function. Half of the participants will receive continuous positive airway pressure (CPAP) treatment for their OSA in addition to their regular CKD treatment, while the other half will only receive their regular CKD treatment.

Detailed Description

Obstructive sleep apnea (OSA) and associated hypoxemia during sleep have been associated with a decline in kidney function. The abnormalities in kidney function associated with OSA have been improved by treatment of OSA with continuous positive airway pressure (CPAP), which is a common and effective therapy for OSA. Up to now, clinical research on the impact of OSA on kidney function has been performed on patients without CKD. This study will examine the impact of CPAP therapy on kidney function in patients with CKD. CKD patients with OSA and nocturnal hypoxemia will be randomized into one of two groups where half will receive treatment of their OSA with CPAP and the other half will not. All participants will have kidney function monitored every 3 months for a year by measurement of serum creatinine and proteinuria. The change in estimated glomerular filtration rate (eGFR) and proteinuria between the two groups will be assessed to determine whether treatment of OSA improves kidney function in patients with CKD.

Registry
clinicaltrials.gov
Start Date
June 2015
End Date
December 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. Patrick Hanly

Principal Investigator

University of Calgary

Eligibility Criteria

Inclusion Criteria

  • CKD stage 3 or 4
  • OSA (RDI\>5) and nocturnal hypoxemia (SaO2 \<90% for \>12% of night)

Exclusion Criteria

  • Failure to meet inclusion criteria
  • Current therapy with CPAP or supplemental oxygen
  • Severe daytime sleepiness reflected by an Epworth Sleepiness Score \>15
  • Any driver who holds a commercial drivers' license or who reports a recent history (past 6 months) of a road traffic accident
  • Severe nocturnal hypoxemia reflected by mean SaO2 \<80% during level 3 sleep testing
  • Daytime hypoxemia reflected by partial pressure of oxygen in arterial blood (PaO2) less than 60 millimetres of mercury (mmHg) during wakefulness
  • Hypoventilation reflected by partial pressure of carbon dioxide in arterial blood (PaCO2) greater than 45 millimetres of mercury (mmHg) during wakefulness
  • Central sleep apnea that accounts for \>50% of the estimated RDI
  • Unable to provide informed consent

Outcomes

Primary Outcomes

eGFR (estimated glomerular filtration rate)

Time Frame: 12 months

Change in eGFR in CPAP group compared to control group.

Secondary Outcomes

  • Pittsburgh Sleep Quality Index (PSQI)(12 months)
  • Epworth Sleepiness Scale (ESS)(12 months)
  • ACR (albumin/creatinine ratio)(12 months)
  • Kidney Disease Quality of Life questionnaire (KDQoL)(12 months)

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