Obstructive Sleep ApneaSASinHD_003NCT02073305
Prognostic Impact of Sleep Apnea on Cardiovascular Morbidity and Mortality, in End Stage Renal Disease Patients
An observational study of Obstructive Sleep Apnea and End Stage Renal Disease, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
Trial summary
The purpose of this study is to prospectively evaluate the impact of sleep apnea on the cardiovascular morbidity and mortality of patients with end-stage renal disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea, End Stage Renal Disease
- What is being tested?
- No Sleep Apnea, Sleep Apnea - untreated and Sleep Apnea - treated
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 200 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2012to Nov 2022
- How long will I take part?
- 7 Years
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with end stage renal disease on renal replacement therapy
Who may be able to join
- end stage renal disease on renal replacement therapy
- age ≥ 18 years
Who cannot join
- unstable congestive heart failure
- active psychiatric disease
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Centre d'Investigation et Recherche sur le Sommeil (CIRS) - Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Canton of Vaud, 1011
About this study
The purpose of this study is to prospectively evaluate the impact of sleep apnea on the cardiovascular morbidity and mortality of patients with end-stage renal disease.
Read the detailed description
Sleep apnea is more prevalent in end stage renal disease patients than in the general population, and may participate to the increased cardiovascular mortality observed in this group of patients. Despite a significant increase in knowledge about the harmful effects of obstructive sleep apnea in the general population, the prognostic impact of sleep apnea in the end stage renal disease population has not yet been investigated.
The purpose of this trial is to investigate the hypothesis that moderate to severe sleep apnea increase the risk of major cardiovascular events in patients with end stage renal disease.
The severity of sleep apnea is measured at inclusion and the patients are followed during 3 years to assess the cardiovascular end-points. The result of the sleep study is communicated to the treating physician and the decision whether to treat or not sleep apnea is left to the treating physician, independently of the study protocol. The comparison will include three groups: patients without sleep apnea, untreated patients with moderate to severe sleep apnea and treated patients with sleep apnea.
- Conditions
- Obstructive Sleep Apnea, End Stage Renal Disease
- Being tested
- No Sleep Apnea, Sleep Apnea - untreated, Sleep Apnea - treated
- Keywords
- obstructive sleep apnea, end stage renal disease, cardiovascular events
- Medical subject headings
- Sleep Apnea, Obstructive, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Sleep ApneaOther
No intervention
Sleep Apnea - untreatedOther
No intervention
Sleep Apnea - treatedDevice
Sleep Apnea treatment by positive pression ventilation (CPAP/BIPAP) or sleep apnea oral appliance
| Study group | Role | What they receive |
|---|---|---|
| No sleep apnea | Subjects with no or light sleep apnea (AHI < 15/h) Receives: Other: No Sleep Apnea | |
| Sleep Apnea - untreated | Subjects with moderate to severe sleep apnea (AHI ≥15/h) and no specific treatment.
Decision to treat or not sleep apnea is left to the treating physician, independently of the study protocol. Receives: Other: Sleep Apnea - untreated | |
| Sleep Apnea - treated | Subjects with treated moderate to severe sleep apnea (AHI ≥15/h). Decision to treat or not sleep apnea is left to the treating physician, independently of the study protocol. Receives: Device: Sleep Apnea - treated |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first major cardiovascular event
composite end-point of all-cause mortality, acute myocardial infarction, hospitalization for acute myocardial ischemia, acute heart failure, stroke, acute peripheral vascular event
Measured: 3 years
Secondary outcomes (6)
Time to cardiovascular death
Measured: 3 years
Time to first non-fatal acute myocardial infarction
Measured: 3 years
Time to first hospitalization for acute myocardial ischemia
Measured: 3 years
Time to first acute heart failure
Measured: 3 years
Time to first non-fatal stroke
Measured: 3 years
Time to first acute peripheral vascular event
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2014 (estimated)
- Study startJun 2012
- Primary completionNov 2021 (estimated)
- Study completionNov 2022 (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.
- More trials run by Centre Hospitalier Universitaire VaudoisThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 7 Years
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Ogna, Centre Hospitalier Universitaire Vaudois
- Investigators
- Raphaël Heinzer, MD, Principal investigator, Centre d'Investigation et Recherche sur le Sommeil (CIRS) - Centre Hospitalier Universitaire Vaudois (CHUV)Adam Ogna, MD, Principal investigator, Centre d'Investigation et Recherche sur le Sommeil (CIRS) - Centre Hospitalier Universitaire Vaudois (CHUV)Valentina Forni Ogna, MD, Principal investigator, Centre d'Investigation et Recherche sur le Sommeil (CIRS) - Centre Hospitalier Universitaire Vaudois (CHUV)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02073305
- Sponsor's protocol ID
- CIRS-SASinHD_003
- Acronym
- SASinHD_003
- Status last verified
- Mar 2020
- First submitted
- 25 Feb 2014
- Last updated
- 4 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Impact of Sleep Apnea on Cardiovascular Morbidity and Mortality, in End Stage Renal Disease Patients
- ClinicalTrials.gov ID
- NCT02073305
- Acronym / sponsor ID
- SASinHD_003 / CIRS-SASinHD_003
- Conditions
- Obstructive Sleep Apnea, End Stage Renal Disease
- Keywords
- obstructive sleep apnea, end stage renal disease, cardiovascular events
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 27 Feb 2014 (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 prospectively evaluate the impact of sleep apnea on the cardiovascular morbidity and mortality of patients with end-stage renal disease.
Detailed description
Sleep apnea is more prevalent in end stage renal disease patients than in the general population, and may participate to the increased cardiovascular mortality observed in this group of patients. Despite a significant increase in knowledge about the harmful effects of obstructive sleep apnea in the general population, the prognostic impact of sleep apnea in the end stage renal disease population has not yet been investigated.
The purpose of this trial is to investigate the hypothesis that moderate to severe sleep apnea increase the risk of major cardiovascular events in patients with end stage renal disease.
The severity of sleep apnea is measured at inclusion and the patients are followed during 3 years to assess the cardiovascular end-points. The result of the sleep study is communicated to the treating physician and the decision whether to treat or not sleep apnea is left to the treating physician, independently of the study protocol. The comparison will include three groups: patients without sleep apnea, untreated patients with moderate to severe sleep apnea and treated patients with sleep apnea.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No sleep apnea | – | Other: No Sleep ApneaSubjects with no or light sleep apnea (AHI < 15/h) |
| Sleep Apnea - untreated | – | Other: Sleep Apnea - untreatedSubjects with moderate to severe sleep apnea (AHI ≥15/h) and no specific treatment. Decision to treat or not sleep apnea is left to the treating physician, independently of the study protocol. |
| Sleep Apnea - treated | – | Device: Sleep Apnea - treatedSubjects with treated moderate to severe sleep apnea (AHI ≥15/h). Decision to treat or not sleep apnea is left to the treating physician, independently of the study protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with end stage renal disease on renal replacement therapy
Key inclusion criteria (2 listed)
- end stage renal disease on renal replacement therapy
- age ≥ 18 years
Key exclusion criteria (2 listed)
- unstable congestive heart failure
- active psychiatric disease
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 |
|---|---|---|
| No Sleep ApneaNo intervention | Other | No sleep apnea |
| Sleep Apnea - untreatedNo intervention | Other | Sleep Apnea - untreated |
| Sleep Apnea - treatedSleep Apnea treatment by positive pression ventilation (CPAP/BIPAP) or sleep apnea oral appliance | Device | Sleep Apnea - treated |
Primary outcome
Time to first major cardiovascular event
Time frame: 3 years
composite end-point of all-cause mortality, acute myocardial infarction, hospitalization for acute myocardial ischemia, acute heart failure, stroke, acute peripheral vascular event
6 secondary outcomes
Time to cardiovascular death
Time frame: 3 years
Time to first non-fatal acute myocardial infarction
Time frame: 3 years
Time to first hospitalization for acute myocardial ischemia
Time frame: 3 years
Time to first acute heart failure
Time frame: 3 years
Time to first non-fatal stroke
Time frame: 3 years
Time to first acute peripheral vascular event
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
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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.
Raphaël Heinzer, MD principal investigator
Centre d'Investigation et Recherche sur le Sommeil (CIRS) - Centre Hospitalier Universitaire Vaudois (CHUV)
Adam Ogna, MD principal investigator
Centre d'Investigation et Recherche sur le Sommeil (CIRS) - Centre Hospitalier Universitaire Vaudois (CHUV)
Valentina Forni Ogna, MD principal investigator
Centre d'Investigation et Recherche sur le Sommeil (CIRS) - Centre Hospitalier Universitaire Vaudois (CHUV)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea and End Stage Renal Disease, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
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 2 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 4 Mar 2020. 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 Switzerland. 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?
Time to first major cardiovascular event (time frame: 3 years). 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 4 Mar 2020.