Sleep Apnea, ObstructiveNCT02420184
Treatment of Obstructive Sleep Apnea in Chronic Kidney Disease
A study testing CPAP and No CPAP in people with Sleep Apnea, Obstructive and Renal Insufficiency, Chronic, run by University of Calgary.
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… Read more about this study
- Who is it for?
- Ages 18 to 76 years
- Conditions the study is for
- Sleep Apnea, Obstructive, Renal Insufficiency, Chronic
- What is being tested?
- CPAP and No CPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 76 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CKD stage 3 or 4
- OSA (RDI>5) and nocturnal hypoxemia (SaO2 <90% for >12% of night)
Who cannot join
- 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
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- 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
About this study
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.
Read the 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.
- Being tested
- CPAP, No CPAP
- Medical subject headings
- Sleep Apnea, Obstructive, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAPDevice
Also called Respironics REMstar AutoA-Flex
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 CPAPOther
Participants randomized into the placebo comparator no CPAP arm will receive standard medical therapy for CKD.
| Study group | Role | What they receive |
|---|---|---|
| CPAP Therapy | Experimental | Participants will receive standard medical care for CKD as well as CPAP therapy for the duration of the study (1 year). Receives: Device: CPAP |
| No CPAP | Placebo comparator | Participants will receive standard medical care for CKD. Receives: Other: No CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
eGFR (estimated glomerular filtration rate)
Change in eGFR in CPAP group compared to control group.
Measured: 12 months
Secondary outcomes (4)
ACR (albumin/creatinine ratio)
Change in albumin/creatinine ratio (ACR) in CPAP group compared to control group.
Measured: 12 months
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.
Measured: 12 months
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
Measured: 12 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2021
- Study completionDec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Patrick Hanly, University of Calgary
- Investigators
- Patrick J Hanly, MD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02420184
- Sponsor's protocol ID
- REB15-0055
- Status last verified
- May 2022
- First submitted
- 14 Apr 2015
- Last updated
- 23 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 33316238Rimke 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.
PubMed 30904853
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Obstructive Sleep Apnea in Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT02420184
- Acronym / sponsor ID
- REB15-0055
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Dec 2021 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 17 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPAP Therapy | Experimental | Device: CPAPParticipants will receive standard medical care for CKD as well as CPAP therapy for the duration of the study (1 year). |
| No CPAP | Placebo comparator | Other: No CPAPParticipants will receive standard medical care for CKD. |
Who may qualify
- Ages
- 18 to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- CKD stage 3 or 4
- OSA (RDI>5) and nocturnal hypoxemia (SaO2 <90% for >12% of night)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPAPAlso: Respironics REMstar AutoA-FlexParticipants 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. | Device | CPAP Therapy |
| No CPAPParticipants randomized into the placebo comparator no CPAP arm will receive standard medical therapy for CKD. | Other | No CPAP |
Primary outcome
eGFR (estimated glomerular filtration rate)
Time frame: 12 months
Change in eGFR in CPAP group compared to control group.
4 secondary outcomes
ACR (albumin/creatinine ratio)
Time frame: 12 months
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 12 months
Epworth Sleepiness Scale (ESS)
Time frame: 12 months
Kidney Disease Quality of Life questionnaire (KDQoL)
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2022.
- Derived from this study: PubMed 33316238Rimke 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.
- Derived from this study: PubMed 30904853Rimke 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick J Hanly, MD principal investigator
University of Calgary
Questions about this trial
What is this clinical trial studying?
A study testing CPAP and No CPAP in people with Sleep Apnea, Obstructive and Renal Insufficiency, Chronic, run by University of Calgary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
eGFR (estimated glomerular filtration rate) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02420184, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2022.