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Sleep Apnea Screening

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ClinicalTrials.gov Identifier: NCT02569749
Recruitment Status : Terminated (Administrative reasons)
First Posted : October 7, 2015
Last Update Posted : November 3, 2015
Sponsor:
Information provided by (Responsible Party):
Arrhythmia Network Technology S.L.

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
Sleep Apnea/Hypopnea Syndrome 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

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Study Type : Observational [Patient Registry]
Actual Enrollment : 15 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Month
Official Title: Sleep Apnea-Hypopnea Syndrome Screening
Study Start Date : June 2015
Estimated Primary Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Group/Cohort 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



Primary Outcome Measures :
  1. Percentage of patients with SAHS in patients with pacemaker indication [ Time Frame: 1 month ]
  2. Percentage of patients with SAHS in patients with ICD or CRTD therapy [ Time Frame: 1 month ]
  3. Percentage of patients with SAHS in patients with heart failure and preserved LVEF [ Time Frame: 1 month ]
  4. Percentage of patients with SAHS in patients with reduced LVEF [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. Percentage of patients with obstructive sleep apnea in all groups [ Time Frame: 1 month ]
  2. Percentage of patients with central sleep apnea in all groups [ Time Frame: 1 month ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability 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%).
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02569749


Locations
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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
Hospital Nuestra Señora de Sonsoles
Ávila, Spain
Sponsors and Collaborators
Arrhythmia Network Technology S.L.
Additional Information:

Publications:

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Responsible Party: Arrhythmia Network Technology S.L.
ClinicalTrials.gov Identifier: NCT02569749    
Other Study ID Numbers: SAHS2
First Posted: October 7, 2015    Key Record Dates
Last Update Posted: November 3, 2015
Last Verified: November 2015
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Syndrome
Disease
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases