Obstructive Sleep ApneaOSA-AKINCT00947479
Effect of Obstructive Sleep Apnea on Central Blood Pressure and Kidney and Endothelial Function
A study testing continuous positive airway pressure (CPAP) in people with Obstructive Sleep Apnea and Acute Kidney Failure, run by Medical University of Lodz at 1 site in Poland.
Trial summary
Obstructive sleep apnea (OSA) is a frequently underdiagnosed condition that has emerged as an increasing medical problem with important social and financial implications worldwide. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Obstructive Sleep Apnea, Acute Kidney Failure, Chronic Kidney Disease
- What is being tested?
- continuous positive airway pressure (CPAP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePoland
- Study dates
- Feb 2009to Jul 2011
- 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 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males with high risk of obstructive sleep apnea syndrome as clinically assessed by coincidence of typical symptoms (e.g. daily somnolence, witnessed apnea, non-refreshing sleep), obesity and high score on Epworth sleepiness scale (ESS) with age range from 18 to 70 years
- Glomerular filtration rate (MDRD formula-based) > 60 ml/min
- Arterial hypertension diagnosed according to the European Society of Hypertension 2007 Guidelines.
Who cannot join
- Mental illness
- Proteinuria >2 g/24h
- Acute and chronic inflammation
- Heart failure III or IV grade
- Uncontrolled diabetes mellitus
- Severe lipid disturbances (triglyceride and/or total cholesterol concentration > 300 mg/dl)
- Chronic administration of drugs with confirmed nephrotoxicity and/or sympathicomimetics
- Obstructive and restrictive pulmonary diseases which may deteriorate the function of the respiratory system
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Medical University
Lodz, Łódź Voivodeship, 90-153
Anna Zawiasa-Bryszewska, MD, (+48)426776709, ania_zawiasa@go2.pl
Małgorzata Kołodziejska, MD, (+48)426776709, niedobrus@o2.pl
About this study
Official title: Effect of Correction of Obstructive Sleep Apnea With Positive Airway Pressure on Central Blood Pressure and Kidney and Endothelial Function
Obstructive sleep apnea (OSA) is a frequently underdiagnosed condition that has emerged as an increasing medical problem with important social and financial implications worldwide. OSA is a well established risk factor for systemic hypertension myocardial infarction or stroke and it has been documented that blood pressure rises in a very consistent fashion during apneic episodes. The incidence of the episodes of apnea during sleep causes repeated subclinical acute kidney injuries (AKI) contributing to the development of CKD. One of the mechanisms responsible for AKI might be endothelial injury followed by an increase of central aortic pressure.
Read the detailed description
Obstructive sleep apnea (OSA) is a frequently underdiagnosed condition that has emerged as an increasing medical problem with important social and financial implications worldwide. Its prevalence may reach 25% in middle-aged men and 11% in women. The most important risk factor for OSA is obesity - every 10% weight gain increases the incidence of the disease 6 times. OSA usually occurs in middle age males and is characterized by history of snoring, daytime somnolence and nocturnal choking or gasping. The underlying cause is transient cessation of airflow due to occlusion of the oropharyngeal tract. Episodes of apnea are considered important if they persist for longer than 10 seconds, but in some cases they may last as long as 2 minutes. The airway occlusion results in recurrent hypoxia, hypercapnia, arousals from sleep, compensatory hyperventilation leading to secondary hypocapnia and generation of exaggerated negative intrathoracic pressure that all can either directly or indirectly be harmful to the cardiovascular system through several pathways like sympathetic activation, inflammation, oxidative stress and endothelial dysfunction. Recurrent episodes of apnea/hypoxia may negatively affect the function of many organs, e.g. they induce (cyclical bradycardia during the apneic episodes, followed by tachycardia during the ensuing ventilatory phases) or rise blood pressure. Moreover, OSA is a well established risk factor for systemic hypertension myocardial infarction or stroke and it has been documented that blood pressure rises in a very consistent fashion during apneic episodes. The mechanisms responsible for this phenomenon are complex because the direct effects of apnea (hypoxemia and low intrathoracic pressure) are modified by cardiopulmonary reflexes. Undoubtedly, the rapid increase in arterial pressure that occurs at the end of an apneic episode is mainly mediated by surges in sympathetic function during the arousal reaction.
Hypertension has emerged as a second, after diabetes mellitus, most frequent cause of chronic kidney disease (CKD). The rise of arterial blood pressure and endothelial damage due to ischaemia during apneic episodes may contribute to CKD. According to the recent findings OSA patients are much more frequently diagnosed with chronic kidney disease. The high frequency of OSA in patients with renal function impairment could be explained by the fact that the most common comorbid conditions of CKD, namely atherosclerosis and diabetes, are also independently associated with his syndrome. The detailed pathogenesis of the strong relation between OSA and CKD has not been investigated so far.
OSA patients are characterized by arterial stiffness, evaluated by pulse-wave velocity (PWV). PWV is a sensitive and validated marker of cardiovascular risk, including premature coronary artery disease, atherosclerosis, stroke and cardiovascular mortality.
The diagnosis of acute kidney injury (AKI) is routinely based on changes in serum creatinine, but its measurements are a poor indicator of acute deterioration in kidney function. First, serum creatinine concentrations might not change until about 50% of kidney function has already been lost. Second, serum creatinine levels can vary widely with age, sex, muscle mass, muscle metabolism, medications and hydration status. Novel, more specific and sensitive biomarkers of AKI are neutrophil gelatinase-associated lipocalin (NGAL), cystatin C, kidney injury molecule 1 (KIM-1), liver-type fatty acid-binding protein (L-FABP), which concentrations in both urine or serum rise significantly in patients with AKI and correlate with severity of kidney injury.
CKD is a devastating illness that has reached epidemic proportions worldwide. CKD is characterized by a progressive decline in kidney function that is associated with excess morbidity and mortality. The deterioration of kidney function can be delayed and patient outcome favorably affected if kidney disease is recognized and treated in a timely manner.
In our study we would like to prove that apneic episodes during sleep can cause repeated renal ischaemia-reperfusion injuries, which may lead to repeated acute subclinical kidney injuries (AKI) contributing to the development of chronic kidney disease.
The aim of this project is to study the influence of sleep apnea syndrome on the markers of acute kidney injury, endothelial function, arterial stiffness and central aortic pressure.
- Being tested
- continuous positive airway pressure (CPAP)
- Keywords
- obstructive sleep apnea, pulse-wave velocity,, acute kidney injury, biomarkers of acute kidney injury
- Medical subject headings
- Sleep Apnea, Obstructive, Acute Kidney Injury, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous positive airway pressure (CPAP)Other
Also called Epworth sleepiness scale (ESS)
After being qualified into the study according to the aforementioned inclusion criteria and after giving an informed consent the polysomnography will be performed in all patients during night rest.In all patients eligible to sleep apnea treatment according to apnea/hypopnea index (AHI, number of apneic/hypopneic episodes per 1 h of effective sleep) from diagnostic polysomnography, CPAP treatment will be introduced under polysomnographic surveillance and the same panel of clinical and biochemical parameters will be evaluated.
| Study group | Role | What they receive |
|---|---|---|
| continuous positive airway pressure (CPAP) | Other | CPAP will be applied in all patients Receives: Other: continuous positive airway pressure (CPAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
presence of acute kidney injury
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2009 (estimated)
- Study startFeb 2009
- Primary completionJun 2010 (estimated)
- Study completionJul 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Lodz
- Sponsor type
- University, hospital or other
- Investigators
- Michał Nowicki, MD, PhD, Study chair, Medical University of Lodz, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00947479
- Sponsor's protocol ID
- UMLodz OSA-AKI
- Acronym
- OSA-AKI
- Status last verified
- Jul 2009
- First submitted
- 27 Jul 2009
- Last updated
- 28 Jul 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Correction of Obstructive Sleep Apnea With Positive Airway Pressure on Central Blood Pressure and Kidney and Endothelial Function
- ClinicalTrials.gov ID
- NCT00947479
- Acronym / sponsor ID
- OSA-AKI / UMLodz OSA-AKI
- Keywords
- obstructive sleep apnea, pulse-wave velocity,, acute kidney injury, biomarkers of acute kidney injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Medical University of LodzUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Jul 2011 (estimated)
- First posted
- 28 Jul 2009 (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.
Obstructive sleep apnea (OSA) is a frequently underdiagnosed condition that has emerged as an increasing medical problem with important social and financial implications worldwide. OSA is a well established risk factor for systemic hypertension myocardial infarction or stroke and it has been documented that blood pressure rises in a very consistent fashion during apneic episodes. The incidence of the episodes of apnea during sleep causes repeated subclinical acute kidney injuries (AKI) contributing to the development of CKD. One of the mechanisms responsible for AKI might be endothelial injury followed by an increase of central aortic pressure.
Detailed description
Obstructive sleep apnea (OSA) is a frequently underdiagnosed condition that has emerged as an increasing medical problem with important social and financial implications worldwide. Its prevalence may reach 25% in middle-aged men and 11% in women. The most important risk factor for OSA is obesity - every 10% weight gain increases the incidence of the disease 6 times. OSA usually occurs in middle age males and is characterized by history of snoring, daytime somnolence and nocturnal choking or gasping. The underlying cause is transient cessation of airflow due to occlusion of the oropharyngeal tract. Episodes of apnea are considered important if they persist for longer than 10 seconds, but in some cases they may last as long as 2 minutes. The airway occlusion results in recurrent hypoxia, hypercapnia, arousals from sleep, compensatory hyperventilation leading to secondary hypocapnia and generation of exaggerated negative intrathoracic pressure that all can either directly or indirectly be harmful to the cardiovascular system through several pathways like sympathetic activation, inflammation, oxidative stress and endothelial dysfunction. Recurrent episodes of apnea/hypoxia may negatively affect the function of many organs, e.g. they induce (cyclical bradycardia during the apneic episodes, followed by tachycardia during the ensuing ventilatory phases) or rise blood pressure. Moreover, OSA is a well established risk factor for systemic hypertension myocardial infarction or stroke and it has been documented that blood pressure rises in a very consistent fashion during apneic episodes. The mechanisms responsible for this phenomenon are complex because the direct effects of apnea (hypoxemia and low intrathoracic pressure) are modified by cardiopulmonary reflexes. Undoubtedly, the rapid increase in arterial pressure that occurs at the end of an apneic episode is mainly mediated by surges in sympathetic function during the arousal reaction.
Hypertension has emerged as a second, after diabetes mellitus, most frequent cause of chronic kidney disease (CKD). The rise of arterial blood pressure and endothelial damage due to ischaemia during apneic episodes may contribute to CKD. According to the recent findings OSA patients are much more frequently diagnosed with chronic kidney disease. The high frequency of OSA in patients with renal function impairment could be explained by the fact that the most common comorbid conditions of CKD, namely atherosclerosis and diabetes, are also independently associated with his syndrome. The detailed pathogenesis of the strong relation between OSA and CKD has not been investigated so far.
OSA patients are characterized by arterial stiffness, evaluated by pulse-wave velocity (PWV). PWV is a sensitive and validated marker of cardiovascular risk, including premature coronary artery disease, atherosclerosis, stroke and cardiovascular mortality.
The diagnosis of acute kidney injury (AKI) is routinely based on changes in serum creatinine, but its measurements are a poor indicator of acute deterioration in kidney function. First, serum creatinine concentrations might not change until about 50% of kidney function has already been lost. Second, serum creatinine levels can vary widely with age, sex, muscle mass, muscle metabolism, medications and hydration status. Novel, more specific and sensitive biomarkers of AKI are neutrophil gelatinase-associated lipocalin (NGAL), cystatin C, kidney injury molecule 1 (KIM-1), liver-type fatty acid-binding protein (L-FABP), which concentrations in both urine or serum rise significantly in patients with AKI and correlate with severity of kidney injury.
CKD is a devastating illness that has reached epidemic proportions worldwide. CKD is characterized by a progressive decline in kidney function that is associated with excess morbidity and mortality. The deterioration of kidney function can be delayed and patient outcome favorably affected if kidney disease is recognized and treated in a timely manner.
In our study we would like to prove that apneic episodes during sleep can cause repeated renal ischaemia-reperfusion injuries, which may lead to repeated acute subclinical kidney injuries (AKI) contributing to the development of chronic kidney disease.
The aim of this project is to study the influence of sleep apnea syndrome on the markers of acute kidney injury, endothelial function, arterial stiffness and central aortic pressure.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| continuous positive airway pressure (CPAP) | Other | Other: continuous positive airway pressure (CPAP)CPAP will be applied in all patients |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males with high risk of obstructive sleep apnea syndrome as clinically assessed by coincidence of typical symptoms (e.g. daily somnolence, witnessed apnea, non-refreshing sleep), obesity and high score on Epworth sleepiness scale (ESS) with age range from 18 to 70 years
- Glomerular filtration rate (MDRD formula-based) > 60 ml/min
- Arterial hypertension diagnosed according to the European Society of Hypertension 2007 Guidelines.
Key exclusion criteria (8 listed)
- Mental illness
- Proteinuria >2 g/24h
- Acute and chronic inflammation
- Heart failure III or IV grade
- Uncontrolled diabetes mellitus
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 |
|---|---|---|
| continuous positive airway pressure (CPAP)Also: Epworth sleepiness scale (ESS)After being qualified into the study according to the aforementioned inclusion criteria and after giving an informed consent the polysomnography will be performed in all patients during night rest.In all patients eligible to sleep apnea treatment according to apnea/hypopnea index (AHI, number of apneic/hypopneic episodes per 1 h of effective sleep) from diagnostic polysomnography, CPAP treatment will be introduced under polysomnographic surveillance and the same panel of clinical and biochemical parameters will be evaluated. | Other | continuous positive airway pressure (CPAP) |
Primary outcome
presence of acute kidney injury
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2009.
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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.
Michał Nowicki, MD, PhD study chair
Medical University of Lodz, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing continuous positive airway pressure (CPAP) in people with Obstructive Sleep Apnea and Acute Kidney Failure, run by Medical University of Lodz at 1 site in Poland.
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 3 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 28 Jul 2009. 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 Poland. 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?
Contact Michał Nowicki, MD, PhD ((+48)426776709, nefro@wp.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
presence of acute kidney injury (time frame: one year). 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 28 Jul 2009.