Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
15 participants
OBSERVATIONAL
2015-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Sleep Apnea-hypopnea Syndrome (SAHS) and Ventricular Arrhythmias
NCT00765713
Minimally Invasive Detection of a Sleep Apnoea
NCT03760159
Validation of the Peripheral Arterial Tone to Detect Sleep-disordered Breathing in Patients With Chronic Heart Failure
NCT02760680
Long-term Cardiovascular Outcomes in Patients With RH and OSA With or Without Treatment With CPAP
NCT03002558
Validation of the "ApneaScan" Algorithm for the Detection of Sleep Disordered Breathing in Chronic Heart Failure
NCT01979120
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group 1
Patients with pacemaker indication (pacemaker already implanted or to be implanted)
Berlin and Epworth questionaries
Sleep apnea monitoring in those patients in whom a pacemaker with monitoring apnea system has been implanted.
Night polygraph / Polysomnography
Group 2
Patients with ICD or CRTD therapy indication (device already implanted or to be implanted)
Berlin and Epworth questionaries
Night polygraph / Polysomnography
Group 3
Patients with heart failure an preserved LVEF (40-50%)
Berlin and Epworth questionaries
Night polygraph / Polysomnography
Group 4
Patients with heart failure and reduced LVEF (\<40%)
Berlin and Epworth questionaries
Night polygraph / Polysomnography
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Berlin and Epworth questionaries
Sleep apnea monitoring in those patients in whom a pacemaker with monitoring apnea system has been implanted.
Night polygraph / Polysomnography
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Arrhythmia Network Technology S.L.
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital Nuestra Señora de Sonsoles
Ávila, , Spain
Hospital Infanta Cristina
Badajoz, , Spain
Hospital Universitario de Burgos
Burgos, , Spain
Hospital General Universitario de Ciudad Real
Ciudad Real, , 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
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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. doi: 10.1093/sleep/20.9.705.
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. doi: 10.1056/NEJM199304293281704.
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.
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.
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. doi: 10.1093/sleep/22.2.225.
Fietze I, Rottig 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. doi: 10.1159/000029509.
Garrigue S, Pepin JL, Defaye P, Murgatroyd F, Poezevara Y, Clementy J, Levy 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. doi: 10.1161/CIRCULATIONAHA.106.659706. Epub 2007 Mar 12.
Pepin JL, Chouri-Pontarollo N, Tamisier R, Levy 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. doi: 10.1016/j.smrv.2005.10.003. Epub 2005 Dec 22.
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. doi: 10.1016/j.ijcard.2004.12.068.
Tremel F, Pepin JL, Veale D, Wuyam B, Siche JP, Mallion JM, Levy 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. doi: 10.1053/euhj.1999.1546.
Defaye P, de la Cruz I, Marti-Almor J, Villuendas R, Bru P, Senechal J, Tamisier R, Pepin 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.
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. doi: 10.1161/01.cir.97.21.2154.
Arias MA, Garcia-Rio F, Alonso-Fernandez A, Sanchez AM. [Sleep apnea-hypopnea syndromes and heart failure]. Rev Esp Cardiol. 2007 Apr;60(4):415-27. Spanish.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SAHS2
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.