Sleep Apnea Screening

Sleep Apnea-Hypopnea Syndrome Screening

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02569749

Enrollment

Registered

2015-10-07

Start date

2015-06-30

Completion date

Unknown

Last updated

2015-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Apnea/Hypopnea Syndrome

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.

Interventions

OTHERBerlin and Epworth questionaries

OTHERSleep apnea monitoring in those patients in whom a pacemaker with monitoring apnea system has been implanted.

OTHERNight polygraph / Polysomnography

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	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

Measure	Time frame
Percentage of patients with central sleep apnea in all groups	1 month
Percentage of patients with obstructive sleep apnea in all groups	1 month

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026