Sleep Apnea Screening

November 2, 2015 updated by: Arrhythmia Network Technology S.L.

Sleep Apnea-Hypopnea Syndrome Screening

To assess the incidence of Sleep Apnea-Hypopnea Syndrome (SAHS), both obstructive and central, in patients with: 1) pacemaker indication; 2) implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRTD), 3) heart failure and preserved left ventricular ejection fraction (LVEF) and 4) heart failure and reduced LVEF.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Badajoz, Spain
        • Hospital Infanta Cristina
      • Burgos, Spain
        • Hospital Universitario de Burgos
      • Ciudad Real, Spain
        • Hospital General Universitario de Ciudad Real
      • Madrid, Spain
        • Hospital Clinico Universitario San Carlos
      • Madrid, Spain
        • Hospital Universitario La Paz
      • Madrid, Spain
        • Hospital Universitario Puerta de Hierro
      • Madrid, Spain
        • HM hospitales
      • Madrid, Spain
        • Hospital Universitario de Fuenlabrada
      • Ávila, Spain
        • Hospital Nuestra Señora de Sonsoles

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients to be included in the registry:

  • 200 patients with pacemaker indication in whom a pacemaker with sleep apnea monitoring system has been implanted.
  • 100 patients with pacemaker indication in whom a pacemaker with no sleep apnea monitoring system has been implanted.
  • 100 patients with ICD or CRDT therapy indication.
  • 100 patients with heart failure and preserved LVEF (40-50%).
  • 100 patients with heart failure and reduced LVEF (<40%).

Description

Inclusion Criteria:

  • Age 18 years or older
  • No previous diagnosis of sleep apnea

  • Fulfilling at least one of the following:

    1. Pacemaker indication
    2. ICD or CRTD therapy indication
    3. Heart failure and preserved LVEF (40-50%)
    4. Heart failure and reduced LVEF (<40%)
  • Signed informed consent

Exclusion Criteria:

  • Age younger than 18 years
  • Renal hemodialysis
  • Cardiac transplant indication
  • Women who are pregnant
  • Advanced cancer
  • Enrollment in another investigational study
  • Able and willing to comply with all testing and requirements
  • Patient not suitable for inclusion due to psychiatric conditions or short life expectancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Patients with pacemaker indication (pacemaker already implanted or to be implanted)
Other: Berlin and Epworth questionaries
Other: Sleep apnea monitoring in those patients in whom a pacemaker with monitoring apnea system has been implanted.
Other: Night polygraph / Polysomnography
Group 2
Patients with ICD or CRTD therapy indication (device already implanted or to be implanted)
Other: Berlin and Epworth questionaries
Other: Night polygraph / Polysomnography
Group 3
Patients with heart failure an preserved LVEF (40-50%)
Other: Berlin and Epworth questionaries
Other: Night polygraph / Polysomnography
Group 4
Patients with heart failure and reduced LVEF (<40%)
Other: Berlin and Epworth questionaries
Other: Night polygraph / Polysomnography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients with SAHS in patients with pacemaker indication
Time Frame: 1 month
1 month
Percentage of patients with SAHS in patients with ICD or CRTD therapy
Time Frame: 1 month
1 month
Percentage of patients with SAHS in patients with heart failure and preserved LVEF
Time Frame: 1 month
1 month
Percentage of patients with SAHS in patients with reduced LVEF
Time Frame: 1 month
1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients with obstructive sleep apnea in all groups
Time Frame: 1 month
1 month
Percentage of patients with central sleep apnea in all groups
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arrhythmia Network Technology S.L.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Anticipated)

March 1, 2016

Study Registration Dates

First Submitted

October 6, 2015

First Submitted That Met QC Criteria

October 6, 2015

First Posted (Estimate)

October 7, 2015

Study Record Updates

Last Update Posted (Estimate)

November 3, 2015

Last Update Submitted That Met QC Criteria

November 2, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAHS2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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