Treatment of Obstructive Sleep Apnea in Chronic Kidney Disease
NCT ID: NCT02420184
Last Updated: 2022-05-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
57 participants
INTERVENTIONAL
2015-06-30
2021-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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CPAP Therapy
Participants will receive standard medical care for CKD as well as CPAP therapy for the duration of the study (1 year).
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.
No CPAP
Participants will receive standard medical care for CKD.
No CPAP
Participants randomized into the placebo comparator no CPAP arm will receive standard medical therapy for CKD.
Interventions
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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.
No CPAP
Participants randomized into the placebo comparator no CPAP arm will receive standard medical therapy for CKD.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* OSA (RDI\>5) and nocturnal hypoxemia (SaO2 \<90% for \>12% of night)
* 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
18 Years
76 Years
ALL
No
Sponsors
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University of Calgary
OTHER
Responsible Party
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Dr. Patrick Hanly
Principal Investigator
Principal Investigators
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Patrick J Hanly, MD
Role: PRINCIPAL_INVESTIGATOR
University of Calgary
References
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Rimke AN, Ahmed SB, Turin TC, Pendharkar SR, Raneri JK, Lynch EJ, Hanly PJ. Effect of CPAP Therapy on Kidney Function in Patients With Chronic Kidney Disease: A Pilot Randomized Controlled Trial. Chest. 2021 May;159(5):2008-2019. doi: 10.1016/j.chest.2020.11.052. Epub 2020 Dec 13.
Rimke AN, Ahmed SB, Turin TC, Pendharkar SR, Raneri JK, Lynch EJ, Hanly PJ. Effect of CPAP therapy on kidney function in patients with obstructive sleep apnoea and chronic kidney disease: a protocol for a randomised controlled clinical trial. BMJ Open. 2019 Mar 23;9(3):e024632. doi: 10.1136/bmjopen-2018-024632.
Other Identifiers
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REB15-0055
Identifier Type: -
Identifier Source: org_study_id
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