Sleep Apnea Screening

Study Overview
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Brief Summary
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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.

Official Title
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Sleep Apnea-Hypopnea Syndrome Screening

Conditions
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Sleep Apnea/Hypopnea Syndrome

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years or older No previous diagnosis of sleep apnea Fulfilling at least one of the following: Pacemaker indication ICD or CRTD therapy indication Heart failure and preserved LVEF (40-50%) 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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