Prognostic Impact of Sleep Apnea on Cardiovascular Morbidity and Mortality, in End Stage Renal Disease Patients (SASinHD_003)

Vaud University Hospital Center

Status: Unknown

Conditions: End Stage Renal Disease; Obstructive Sleep Apnea

Treatments: Other: Sleep Apnea - untreated; Other: No Sleep Apnea; Device: Sleep Apnea - treated

Study type: Observational

Funder types: Other

Identifiers

NCT02073305

CIRS-SASinHD_003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• unstable congestive heart failure
• active psychiatric disease

Trial design

200 participants in 3 patient groups

No sleep apnea

Description:

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

Treatment:

Other: No Sleep Apnea

Sleep Apnea - untreated

Description:

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.

Treatment:

Other: Sleep Apnea - untreated

Sleep Apnea - treated

Description:

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.

Treatment:

Device: Sleep Apnea - treated