Treatment of Obstructive Sleep Apnea in Chronic Kidney Disease

Sleep Apnea, Obstructive Clinical Trial

Official title:

Treatment of Obstructive Sleep Apnea in Chronic Kidney Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02420184
• Other study ID #: REB15-0055
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: December 2021

Study information

• Verified date: May 2022
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 76 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Kidney Diseases
• Renal Insufficiency
• Renal Insufficiency, Chronic
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Calgary

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	eGFR (estimated glomerular filtration rate)	Change in eGFR in CPAP group compared to control group.	12 months
Secondary	ACR (albumin/creatinine ratio)	Change in albumin/creatinine ratio (ACR) in CPAP group compared to control group.	12 months
Secondary	Pittsburgh Sleep Quality Index (PSQI)	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.	12 months
Secondary	Epworth Sleepiness Scale (ESS)	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	12 months
Secondary	Kidney Disease Quality of Life questionnaire (KDQoL)	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.	12 months