Skip to main content
OpenTrials
Completed

NCT Number: NCT02420184

Treatment of Obstructive Sleep Apnea in Chronic Kidney Disease

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sleep Apnea, Obstructive Apnea Chronic Disease Disease Attributes Dyssomnias Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders Urogenital Diseases Urologic Diseases

Age range

18 year–76 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CPAP

Device

Participants randomized into the experimental CPAP therapy arm will receive CPAP in addition to their standard medical therapy for CKD. CPAP will be worn whenever the participant sleeps for the duration of the study.

Other names: Respironics REMstar AutoA-Flex

No CPAP

Other

Participants randomized into the placebo comparator no CPAP arm will receive standard medical therapy for CKD.

Primary outcomes

  1. eGFR (estimated glomerular filtration rate)

    Time frame: 12 months

    Change in eGFR in CPAP group compared to control group.

Secondary outcomes

  1. ACR (albumin/creatinine ratio)

    Time frame: 12 months

    Change in albumin/creatinine ratio (ACR) in CPAP group compared to control group.

  2. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 12 months

    The PSQI is a validated, self-reported questionnaire that measures subjective sleep quality by asking patients about difficulties initiating and maintaining sleep. The change in PSQI in CPAP group will be compared to control.

  3. Epworth Sleepiness Scale (ESS)

    Time frame: 12 months

    The ESS is a self-reported questionnaire that measures subjective sleepiness. Patients are asked to rate the tendency to fall asleep in eight passive situations. The change in ESS in the CPAP group will be compared to control

  4. Kidney Disease Quality of Life questionnaire (KDQoL)

    Time frame: 12 months

    The KDQoL focuses on the health concerns of patients with chronic kidney disease26. This has been modified slightly, by omitting 2 questions that ask about dialysis, to make it suitable for the non-dialysis CKD population. The change in KDQoL in the CPAP group will be compared to control.

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Registry information

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Apr 17, 2015
Registry last updated
May 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.