Treatment of Obstructive Sleep Apnea in Chronic Kidney Disease

University of Calgary

Status: Completed

Conditions: Sleep Apnea, Obstructive; Renal Insufficiency, Chronic

Treatments: Device: CPAP; Other: No CPAP

Study type: Interventional

Funder types: Other

Identifiers

NCT02420184

REB15-0055

Details and patient eligibility

About

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.

Full 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.

Enrollment: 57 patients

Sex: All

Ages: 18 to 76 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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57 participants in 2 patient groups, including a placebo group

CPAP Therapy

Experimental group

Description:

Participants will receive standard medical care for CKD as well as CPAP therapy for the duration of the study (1 year).

Treatment:

Device: CPAP

No CPAP

Placebo Comparator group

Description:

Participants will receive standard medical care for CKD.

Treatment:

Other: No CPAP