Clinical trial NCT02569749: Sleep Apnea Screening
Official title: Sleep Apnea-Hypopnea Syndrome Screening
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Sleep Apnea/Hypopnea Syndrome
Lead sponsor: Arrhythmia Network Technology S.L.
Sponsor class: OTHER
First posted: 2015-10-07
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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%).

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of patients with SAHS in patients with pacemaker indication
timeFrame: 1 month
measure: Percentage of patients with SAHS in patients with ICD or CRTD therapy
timeFrame: 1 month
measure: Percentage of patients with SAHS in patients with heart failure and preserved LVEF
timeFrame: 1 month
measure: Percentage of patients with SAHS in patients with reduced LVEF
timeFrame: 1 month
Secondary outcomes:
measure: Percentage of patients with obstructive sleep apnea in all groups
timeFrame: 1 month
measure: Percentage of patients with central sleep apnea in all groups
timeFrame: 1 month
Other outcomes:
Locations:
city: Badajoz
country: Spain
facility: Hospital Infanta Cristina
city: Burgos
country: Spain
facility: Hospital Universitario de Burgos
city: Ciudad Real
country: Spain
facility: Hospital General Universitario de Ciudad Real
city: Madrid
country: Spain
facility: HM Hospitales
city: Madrid
country: Spain
facility: Hospital Clínico Universitario San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario de Fuenlabrada
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital Universitario Puerta de Hierro
city: Ávila
country: Spain
facility: Hospital Nuestra Señora de Sonsoles
Study officials:
References:
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