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

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-30

Study Completion Date

2022-11-30

Brief Summary

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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

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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

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Obstructive Sleep Apnea End Stage Renal Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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No sleep apnea

Subjects with no or light sleep apnea (AHI \< 15/h)

No Sleep Apnea

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type DEVICE

Sleep Apnea treatment by positive pression ventilation (CPAP/BIPAP) or sleep apnea oral appliance

Interventions

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No Sleep Apnea

No intervention

Intervention Type OTHER

Sleep Apnea - untreated

No intervention

Intervention Type OTHER

Sleep Apnea - treated

Sleep Apnea treatment by positive pression ventilation (CPAP/BIPAP) or sleep apnea oral appliance

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* end stage renal disease on renal replacement therapy
* age ≥ 18 years

Exclusion Criteria

* unstable congestive heart failure
* active psychiatric disease
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire Vaudois

OTHER

Sponsor Role lead

Responsible Party

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Adam Ogna

Centre d'Investigation et Recherche sur le Sommeil (CIRS)

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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Switzerland

Other Identifiers

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CIRS-SASinHD_003

Identifier Type: -

Identifier Source: org_study_id

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