Sleep Apnea Screening

Terminated

• Conditions: Sleep Apnea/Hypopnea Syndrome
• Interventions: 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

• Registration Number: NCT02569749
• Lead Sponsor: Arrhythmia Network Technology S.L.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-10-06
• Study First Submitted QC: 2015-10-06
• Study First Posted: 2015-10-07
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-02
• Last Update Posted: 2015-11-03
• Primary Completion: 2016-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Percentage of patients with SAHS in patients with ICD or CRTD therapy	1 month
Percentage of patients with SAHS in patients with reduced LVEF	1 month
Percentage of patients with SAHS in patients with pacemaker indication	1 month
Percentage of patients with SAHS in patients with heart failure and preserved LVEF	1 month

Secondary Outcome Measures

Name	Time	Method
Percentage of patients with central sleep apnea in all groups	1 month
Percentage of patients with obstructive sleep apnea in all groups	1 month

Trial Locations

Locations (9)

Hospital Infanta Cristina; 🇪🇸 Badajoz, Spain

Hospital General Universitario de Ciudad Real; 🇪🇸 Ciudad Real, Spain

Hospital Universitario de Burgos; 🇪🇸 Burgos, Spain

HM Hospitales; 🇪🇸 Madrid, Spain

Hospital Clínico Universitario San Carlos; 🇪🇸 Madrid, Spain

Hospital Universitario de Fuenlabrada; 🇪🇸 Madrid, Spain

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain

Hospital Universitario Puerta de Hierro; 🇪🇸 Madrid, Spain

Hospital Nuestra Señora de Sonsoles; 🇪🇸 Ávila, Spain