Sleep Apnea Screening
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Group 1 Patients with pacemaker indication (pacemaker already implanted or to be implanted) |
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
|
| Group 2 Patients with ICD or CRTD therapy indication (device already implanted or to be implanted) |
Other: Berlin and Epworth questionaries
Other: Night polygraph / Polysomnography
|
| Group 3 Patients with heart failure an preserved LVEF (40-50%) |
Other: Berlin and Epworth questionaries
Other: Night polygraph / Polysomnography
|
| Group 4 Patients with heart failure and reduced LVEF (<40%) |
Other: Berlin and Epworth questionaries
Other: Night polygraph / Polysomnography
|
Outcome Measures
Primary Outcome Measures
- 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
- Percentage of patients with obstructive sleep apnea in all groups [1 month]
- Percentage of patients with central sleep apnea in all groups [1 month]
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Infanta Cristina | Badajoz | Spain | ||
| 2 | Hospital Universitario de Burgos | Burgos | Spain | ||
| 3 | Hospital General Universitario de Ciudad Real | Ciudad Real | Spain | ||
| 4 | HM Hospitales | Madrid | Spain | ||
| 5 | Hospital Clínico Universitario San Carlos | Madrid | Spain | ||
| 6 | Hospital Universitario de Fuenlabrada | Madrid | Spain | ||
| 7 | Hospital Universitario La Paz | Madrid | Spain | ||
| 8 | Hospital Universitario Puerta de Hierro | Madrid | Spain | ||
| 9 | Hospital Nuestra Señora de Sonsoles | Ávila | Spain |
Sponsors and Collaborators
- Arrhythmia Network Technology S.L.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- Arias MA, García-Río F, Alonso-Fernández A, Sánchez AM. [Sleep apnea-hypopnea syndromes and heart failure]. Rev Esp Cardiol. 2007 Apr;60(4):415-27. Review. Spanish.
- Defaye P, de la Cruz I, Martí-Almor J, Villuendas R, Bru P, Sénéchal J, Tamisier R, Pépin JL. A pacemaker transthoracic impedance sensor with an advanced algorithm to identify severe sleep apnea: the DREAM European study. Heart Rhythm. 2014 May;11(5):842-8. doi: 10.1016/j.hrthm.2014.02.011. Epub 2014 Feb 19.
- Fietze I, Röttig J, Quispe-Bravo S, Riedel F, Witte J, Baumann G, Witt C. Sleep apnea syndrome in patients with cardiac pacemaker. Respiration. 2000;67(3):268-71.
- Garrigue S, Pépin JL, Defaye P, Murgatroyd F, Poezevara Y, Clémenty J, Lévy P. High prevalence of sleep apnea syndrome in patients with long-term pacing: the European Multicenter Polysomnographic Study. Circulation. 2007 Apr 3;115(13):1703-9. Epub 2007 Mar 12.
- Javaheri S, Parker TJ, Liming JD, Corbett WS, Nishiyama H, Wexler L, Roselle GA. Sleep apnea in 81 ambulatory male patients with stable heart failure. Types and their prevalences, consequences, and presentations. Circulation. 1998 Jun 2;97(21):2154-9.
- Javaheri S. Sleep disorders in systolic heart failure: a prospective study of 100 male patients. The final report. Int J Cardiol. 2006 Jan 4;106(1):21-8.
- Kasai T, Bradley TD. Obstructive sleep apnea and heart failure: pathophysiologic and therapeutic implications. J Am Coll Cardiol. 2011 Jan 11;57(2):119-27. doi: 10.1016/j.jacc.2010.08.627. Review.
- Marshall NS, Wong KK, Liu PY, Cullen SR, Knuiman MW, Grunstein RR. Sleep apnea as an independent risk factor for all-cause mortality: the Busselton Health Study. Sleep. 2008 Aug;31(8):1079-85.
- Pépin JL, Chouri-Pontarollo N, Tamisier R, Lévy P. Cheyne-Stokes respiration with central sleep apnoea in chronic heart failure: proposals for a diagnostic and therapeutic strategy. Sleep Med Rev. 2006 Feb;10(1):33-47. Epub 2005 Dec 22. Review.
- Ronald J, Delaive K, Roos L, Manfreda J, Bahammam A, Kryger MH. Health care utilization in the 10 years prior to diagnosis in obstructive sleep apnea syndrome patients. Sleep. 1999 Mar 15;22(2):225-9.
- Tremel F, Pépin JL, Veale D, Wuyam B, Siché JP, Mallion JM, Lévy P. High prevalence and persistence of sleep apnoea in patients referred for acute left ventricular failure and medically treated over 2 months. Eur Heart J. 1999 Aug;20(16):1201-9.
- Young T, Evans L, Finn L, Palta M. Estimation of the clinically diagnosed proportion of sleep apnea syndrome in middle-aged men and women. Sleep. 1997 Sep;20(9):705-6.
- Young T, Finn L, Peppard PE, Szklo-Coxe M, Austin D, Nieto FJ, Stubbs R, Hla KM. Sleep disordered breathing and mortality: eighteen-year follow-up of the Wisconsin sleep cohort. Sleep. 2008 Aug;31(8):1071-8.
- Young T, Palta M, Dempsey J, Skatrud J, Weber S, Badr S. The occurrence of sleep-disordered breathing among middle-aged adults. N Engl J Med. 1993 Apr 29;328(17):1230-5.
- SAHS2