NCT02073305

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

February 25, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 27, 2014

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

March 4, 2020

Status Verified

March 1, 2020

Enrollment Period

9.4 years

First QC Date

February 25, 2014

Last Update Submit

March 2, 2020

Conditions

Obstructive Sleep ApneaEnd Stage Renal Disease

Keywords

obstructive sleep apneaend stage renal diseasecardiovascular events

Outcome Measures

Primary Outcomes (1)

  • 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

    3 years

Secondary Outcomes (6)

  • Time to cardiovascular death

    3 years

  • Time to first non-fatal acute myocardial infarction

    3 years

  • Time to first hospitalization for acute myocardial ischemia

    3 years

  • Time to first acute heart failure

    3 years

  • Time to first non-fatal stroke

    3 years

  • +1 more secondary outcomes

Study Arms (3)

No sleep apnea

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

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.

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.

Device: Sleep Apnea - treated

Interventions

No Sleep ApneaOTHER

No intervention

No sleep apnea
Sleep Apnea - untreatedOTHER

No intervention

Sleep Apnea - untreated
Sleep Apnea - treatedDEVICE

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

Sleep Apnea - treated

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with end stage renal disease on renal replacement therapy

You may qualify if:

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

You may not qualify if:

  • unstable congestive heart failure
  • active psychiatric disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre d'Investigation et Recherche sur le Sommeil (CIRS) - Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, Canton of Vaud, 1011, Switzerland

Location

MeSH Terms

Conditions

Sleep Apnea, ObstructiveKidney Failure, Chronic

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesRenal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Raphaël Heinzer, MD

    Centre d'Investigation et Recherche sur le Sommeil (CIRS) - Centre Hospitalier Universitaire Vaudois (CHUV)

    PRINCIPAL INVESTIGATOR

  • Adam Ogna, MD

    Centre d'Investigation et Recherche sur le Sommeil (CIRS) - Centre Hospitalier Universitaire Vaudois (CHUV)

    PRINCIPAL INVESTIGATOR

  • Valentina Forni Ogna, MD

    Centre d'Investigation et Recherche sur le Sommeil (CIRS) - Centre Hospitalier Universitaire Vaudois (CHUV)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
7 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Centre d'Investigation et Recherche sur le Sommeil (CIRS)

Study Record Dates

First Submitted

February 25, 2014

First Posted

February 27, 2014

Study Start

June 1, 2012

Primary Completion

November 1, 2021

Study Completion

November 1, 2022

Last Updated

March 4, 2020

Record last verified: 2020-03

Locations

CH(1)