NCT02569749

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

9 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 6, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 7, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Last Updated

November 3, 2015

Status Verified

November 1, 2015

Enrollment Period

9 months

First QC Date

October 6, 2015

Last Update Submit

November 2, 2015

Conditions

Sleep Apnea/Hypopnea Syndrome

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (2)

  • Percentage of patients with obstructive sleep apnea in all groups

    1 month

  • Percentage of patients with central sleep apnea in all groups

    1 month

Study Arms (4)

Group 1

Patients with pacemaker indication (pacemaker already implanted or to be implanted)

Other: Berlin and Epworth questionariesOther: 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 questionariesOther: Night polygraph / Polysomnography

Group 3

Patients with heart failure an preserved LVEF (40-50%)

Other: Berlin and Epworth questionariesOther: Night polygraph / Polysomnography

Group 4

Patients with heart failure and reduced LVEF (\<40%)

Other: Berlin and Epworth questionariesOther: Night polygraph / Polysomnography

Interventions

Berlin and Epworth questionariesOTHER
Group 1Group 2Group 3Group 4
Sleep apnea monitoring in those patients in whom a pacemaker with monitoring apnea system has been implanted.OTHER
Group 1
Night polygraph / PolysomnographyOTHER
Group 1Group 2Group 3Group 4

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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%).

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Hospital Nuestra Señora de Sonsoles

Ávila, Spain

Location

Hospital Infanta Cristina

Badajoz, Spain

Location

Hospital Universitario de Burgos

Burgos, Spain

Location

Hospital General Universitario de Ciudad Real

Ciudad Real, Spain

Location

HM Hospitales

Madrid, Spain

Location

Hospital Clínico Universitario San Carlos

Madrid, Spain

Location

Hospital Universitario de Fuenlabrada

Madrid, Spain

Location

Hospital Universitario La Paz

Madrid, Spain

Location

Hospital Universitario Puerta de Hierro

Madrid, Spain

Location

Related Publications (14)

  • 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.

    PMID: 9406321BACKGROUND

  • 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.

    PMID: 8464434BACKGROUND

  • 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.

    PMID: 18714779BACKGROUND

  • 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.

    PMID: 18714778BACKGROUND

  • 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.

    PMID: 10201067BACKGROUND

  • 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.

    PMID: 10867594BACKGROUND

  • 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.

    PMID: 17353437BACKGROUND

  • 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.

    PMID: 16376589BACKGROUND

  • 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.

    PMID: 16321661BACKGROUND

  • 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.

    PMID: 10448029BACKGROUND

  • 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.

    PMID: 24561163BACKGROUND

  • 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.

    PMID: 9626176BACKGROUND

  • 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.

    PMID: 17521550BACKGROUND

  • 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.

    PMID: 21211682BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2015

First Posted

October 7, 2015

Study Start

June 1, 2015

Primary Completion

March 1, 2016

Last Updated

November 3, 2015

Record last verified: 2015-11

Locations

ES(9)