Sleep Apnea Screening

Sleep Apnea/Hypopnea Syndrome Clinical Trial

Official title:

Sleep Apnea-Hypopnea Syndrome Screening

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02569749
• Other study ID #: SAHS2
• Status: Terminated
• Phase: N/A
• First received: October 6, 2015
• Last updated: November 2, 2015
• Start date: June 2015

Study information

• Verified date: November 2015
• Source: Arrhythmia Network Technology S.L.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Sleep Apnea/Hypopnea Syndrome

Intervention

Other:
• Berlin and Epworth questionaries

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

• Night polygraph / Polysomnography

Locations

Country	Name	City	State
Spain	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

Sponsors (1)

Lead Sponsor	Collaborator
Arrhythmia Network Technology S.L.

Country where clinical trial is conducted

Spain, 

References & Publications (14)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with SAHS in patients with pacemaker indication		1 month	No
Primary	Percentage of patients with SAHS in patients with ICD or CRTD therapy		1 month	No
Primary	Percentage of patients with SAHS in patients with heart failure and preserved LVEF		1 month	No
Primary	Percentage of patients with SAHS in patients with reduced LVEF		1 month	No
Secondary	Percentage of patients with obstructive sleep apnea in all groups		1 month	No
Secondary	Percentage of patients with central sleep apnea in all groups		1 month	No