Chronic Kidney DiseaseNOSINCT01951248
Central and Peripheral 24-h Blood Pressure Before and After 3 Month of CPAP Treatment in Obstructive Sleep Apnea
A study testing CPAP - continuous airway pressure in people with Chronic Kidney Disease and Obstructive Sleep Apnea, run by Erling Bjerregaard Pedersen at 1 site in Denmark.
Trial summary
The purpose of this study is to investigate the effect of 3 months of continuous positive airway pressure (CPAP) treatment of obstructive sleep apnea (OSA) in moderate to severe cases in patients with chronic kidney disease. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Kidney Disease, Obstructive Sleep Apnea
- What is being tested?
- CPAP - continuous airway pressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2013to Oct 2017
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- renal insufficiency (CKD stage III + IV), estimated glomerular filtration rate (eGFR) 15-59 ml/min/1.73 m2
- Obstructive sleep apnea, AHI> 15 (moderate to severe)
- both men and women
- 18-80 years
Who cannot join
- lack of desire to participate
- malignant disease
- Abuse of drugs or alcohol
- pregnant and lactating
- incompensated heart failure
- atrial fibrillation
- liver disease (alanine aminotransferase> 200)
- Severe chronic obstructive lung disease (Forced expiratory volume in 1 second <50% predicted)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Central and Peripheral 24-h Blood Pressure Measurements in Patients With Chronic Renal Failure and Obstructive Sleep Apnea Before and After Treatment With CPAP
The purpose of this study is to investigate the effect of 3 months of continuous positive airway pressure (CPAP) treatment of obstructive sleep apnea (OSA) in moderate to severe cases in patients with chronic kidney disease. The effect is evaluated on blood pressure levels, particularly nocturnal blood pressure, both central and peripheral, and renal function, including the kidneys treatment of salt and water.
Hypothesis:
Read more
- Central 24-h blood pressure measuring is a reveals fluctuations in blood pressure during the day more accurately than peripheral 24-h blood pressure measuring because the measurement is painless and does not interfere with the patient activities during the daytime or nighttime sleep.
- Central blood pressure is elevated in patients with OSA and falls during treatment with CPAP.
- The renal tubular function relating to the treatment of water and sodium is abnormal in patients with OSA with increased tubular absorption of water via the U-aquaporin 2 (u-AQP2) and of sodium by epithelial sodium channel (ENAC) and is normalized during treatment with CPAP.
4 Quality of life is improved during treatment with CPAP.
Read the detailed description
Approximately 30 patients with chronic kidney disease and obstructive sleep apnea in moderate to severe degree is examined with central and peripheral 24-h blood pressure monitoring, 1 night home polygraphy to determine the degree of sleep apnea, blood and urine samples to determine levels of u-AQP2, u-ENAC, plasma renin concentration (PRC), s-angiotensin II (p-angII), p-aldosterone, p-vasopressin (p-avp) and p-endothelin, before the start treatment with CPAP for sleep apnea.
After 3 month of treatment all the above described is repeated to determine effects of CPAP treatment on blood pressure levels during the day, changes i apnea hypopnea index (AHI) and the kidneys treatment of salt and water.
- Conditions
- Chronic Kidney Disease, Obstructive Sleep Apnea
- Being tested
- CPAP - continuous airway pressure
- Keywords
- chronic kidney disease, obstructive sleep apnea, 24-h blood pressure, central blood pressure, peripheral blood pressure
- Medical subject headings
- Renal Insufficiency, Chronic, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAP - continuous airway pressureDevice
Also called S9 AutoSet from ResMed/Maribo Medico, or, REMstar Auto A-Flex from Phillips/Respirsonics
3 months of treatment with CPAP treatment
| Study group | Role | What they receive |
|---|---|---|
| CPAP treatment | Experimental | Patients with chronic kidney disease and moderate to severe obstructive sleep apnea is treated 3 months with CPAP treatment Receives: Device: CPAP - continuous airway pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
decrease in systolic night time blood pressure
The difference in systolic blood pressure at night by 24-h blood pressure at baseline and 3 months of treatment of OSA with CPAP in patients with chronic renal insufficiency.
Measured: 3 months
Secondary outcomes (5)
difference in systolic blood pressure at night by central blood pressure monitoring
The difference in systolic blood pressure at night by central 24-h blood pressure monitoring before and after 3 months of treatment of OSA with CPAP in patients with chronic renal insufficiency
Measured: 3 months
systolic and diastolic blood pressure throughout the day
The difference in systolic blood pressure and diastolic blood pressure throughout the day, in the daytime and in night time between measurements with peripheral 24-h blood pressure and central 24-h blood pressure before and after 3 months of treatment with CPAP.
Measured: 3 months
correlation between blood pressure, OSA and kidney function
The correlation between the treatment effect on blood pressure levels on the one hand and the severity of OSA prior to initiation of treatment and renal function measured by estimates glomerular filtration rate, on the other
Measured: 3 months
U-AQP2 and u-ENaCɣ in day urine. PRC, p-AngII, p-Aldo. P-AVP and p-endothelial.
U-AQP2 and u-ENaCɣ in day urine. PRC, p-AngII, p-Aldo. P-AVP and p-endothelial. Difference in these before and after 3 months of treatment
Measured: 3 months
quality af life
difference in the quality of life before and after 3 months of CPAP treatment
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2013 (estimated)
- Study startDec 2013
- Primary completionOct 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erling Bjerregaard Pedersen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Erling Bjerregaard Pedersen, Regional Hospital Holstebro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01951248
- Sponsor's protocol ID
- BGH-3-2013
- Other IDs
- M-2013-285-13
- Acronym
- NOSI
- Status last verified
- Oct 2014
- First submitted
- 23 Sep 2013
- Last updated
- 9 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central and Peripheral 24-h Blood Pressure Measurements in Patients With Chronic Renal Failure and Obstructive Sleep Apnea Before and After Treatment With CPAP
- ClinicalTrials.gov ID
- NCT01951248
- Acronym / sponsor ID
- NOSI / BGH-3-2013
- Conditions
- Chronic Kidney Disease, Obstructive Sleep Apnea
- Keywords
- chronic kidney disease, obstructive sleep apnea, 24-h blood pressure, central blood pressure, peripheral blood pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Erling Bjerregaard PedersenUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 26 Sep 2013 (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.
The purpose of this study is to investigate the effect of 3 months of continuous positive airway pressure (CPAP) treatment of obstructive sleep apnea (OSA) in moderate to severe cases in patients with chronic kidney disease. The effect is evaluated on blood pressure levels, particularly nocturnal blood pressure, both central and peripheral, and renal function, including the kidneys treatment of salt and water.
Hypothesis:
- Central 24-h blood pressure measuring is a reveals fluctuations in blood pressure during the day more accurately than peripheral 24-h blood pressure measuring because the measurement is painless and does not interfere with the patient activities during the daytime or nighttime sleep.
- Central blood pressure is elevated in patients with OSA and falls during treatment with CPAP.
- The renal tubular function relating to the treatment of water and sodium is abnormal in patients with OSA with increased tubular absorption of water via the U-aquaporin 2 (u-AQP2) and of sodium by epithelial sodium channel (ENAC) and is normalized during treatment with CPAP.
4 Quality of life is improved during treatment with CPAP.
Detailed description
Approximately 30 patients with chronic kidney disease and obstructive sleep apnea in moderate to severe degree is examined with central and peripheral 24-h blood pressure monitoring, 1 night home polygraphy to determine the degree of sleep apnea, blood and urine samples to determine levels of u-AQP2, u-ENAC, plasma renin concentration (PRC), s-angiotensin II (p-angII), p-aldosterone, p-vasopressin (p-avp) and p-endothelin, before the start treatment with CPAP for sleep apnea.
After 3 month of treatment all the above described is repeated to determine effects of CPAP treatment on blood pressure levels during the day, changes i apnea hypopnea index (AHI) and the kidneys treatment of salt and water.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CPAP treatment | Experimental | Device: CPAP - continuous airway pressurePatients with chronic kidney disease and moderate to severe obstructive sleep apnea is treated 3 months with CPAP treatment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- renal insufficiency (CKD stage III + IV), estimated glomerular filtration rate (eGFR) 15-59 ml/min/1.73 m2
- Obstructive sleep apnea, AHI> 15 (moderate to severe)
- both men and women
- 18-80 years
Key exclusion criteria (8 listed)
- lack of desire to participate
- malignant disease
- Abuse of drugs or alcohol
- pregnant and lactating
- incompensated heart failure
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 |
|---|---|---|
| CPAP - continuous airway pressureAlso: S9 AutoSet from ResMed/Maribo Medico, or, REMstar Auto A-Flex from Phillips/Respirsonics3 months of treatment with CPAP treatment | Device | CPAP treatment |
Primary outcome
decrease in systolic night time blood pressure
Time frame: 3 months
The difference in systolic blood pressure at night by 24-h blood pressure at baseline and 3 months of treatment of OSA with CPAP in patients with chronic renal insufficiency.
5 secondary outcomes
difference in systolic blood pressure at night by central blood pressure monitoring
Time frame: 3 months
systolic and diastolic blood pressure throughout the day
Time frame: 3 months
correlation between blood pressure, OSA and kidney function
Time frame: 3 months
U-AQP2 and u-ENaCɣ in day urine. PRC, p-AngII, p-Aldo. P-AVP and p-endothelial.
Time frame: 3 months
quality af life
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP - continuous airway pressure in people with Chronic Kidney Disease and Obstructive Sleep Apnea, run by Erling Bjerregaard Pedersen at 1 site in Denmark.
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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 9 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
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?
decrease in systolic night time blood pressure (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Oct 2014.