Sleep Apnea Screening

Arrhythmia Network Technology S.L.

Status: Terminated

Conditions: Sleep Apnea/Hypopnea Syndrome

Treatments: 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

Study type: Observational

Funder types: Other

Identifiers

NCT02569749

SAHS2

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

15 participants in 4 patient groups

Group 1

Description:

Patients with pacemaker indication (pacemaker already implanted or to be implanted)

Treatment:

Other: Night polygraph / Polysomnography

Other: Berlin and Epworth questionaries

Other: Sleep apnea monitoring in those patients in whom a pacemaker with monitoring apnea system has been implanted.

Group 2

Description:

Patients with ICD or CRTD therapy indication (device already implanted or to be implanted)

Treatment:

Other: Night polygraph / Polysomnography

Other: Berlin and Epworth questionaries

Group 3

Description:

Patients with heart failure an preserved LVEF (40-50%)

Treatment:

Other: Night polygraph / Polysomnography

Other: Berlin and Epworth questionaries

Group 4

Description:

Patients with heart failure and reduced LVEF (\<40%)

Treatment:

Other: Night polygraph / Polysomnography

Other: Berlin and Epworth questionaries