Prognostic Impact of Sleep Apnea on Cardiovascular Morbidity and Mortality, in End Stage Renal Disease Patients
NCT ID: NCT02073305
Last Updated: 2020-03-04
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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UNKNOWN
200 participants
OBSERVATIONAL
2012-06-30
2022-11-30
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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No sleep apnea
Subjects with no or light sleep apnea (AHI \< 15/h)
No Sleep Apnea
No intervention
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.
Sleep Apnea - untreated
No intervention
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.
Sleep Apnea - treated
Sleep Apnea treatment by positive pression ventilation (CPAP/BIPAP) or sleep apnea oral appliance
Interventions
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No Sleep Apnea
No intervention
Sleep Apnea - untreated
No intervention
Sleep Apnea - treated
Sleep Apnea treatment by positive pression ventilation (CPAP/BIPAP) or sleep apnea oral appliance
Eligibility Criteria
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Inclusion Criteria
* age ≥ 18 years
Exclusion Criteria
* active psychiatric disease
18 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire Vaudois
OTHER
Responsible Party
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Adam Ogna
Centre d'Investigation et Recherche sur le Sommeil (CIRS)
Principal Investigators
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Raphaël Heinzer, MD
Role: PRINCIPAL_INVESTIGATOR
Centre d'Investigation et Recherche sur le Sommeil (CIRS) - Centre Hospitalier Universitaire Vaudois (CHUV)
Adam Ogna, MD
Role: PRINCIPAL_INVESTIGATOR
Centre d'Investigation et Recherche sur le Sommeil (CIRS) - Centre Hospitalier Universitaire Vaudois (CHUV)
Valentina Forni Ogna, MD
Role: PRINCIPAL_INVESTIGATOR
Centre d'Investigation et Recherche sur le Sommeil (CIRS) - Centre Hospitalier Universitaire Vaudois (CHUV)
Locations
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Centre d'Investigation et Recherche sur le Sommeil (CIRS) - Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Canton of Vaud, Switzerland
Countries
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Other Identifiers
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CIRS-SASinHD_003
Identifier Type: -
Identifier Source: org_study_id
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