Trial document





This trial has been registered retrospectively.
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  DRKS00008567

Trial Description

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Title

Recognition of Sleep Apnea by Analysis of the Routine Holter ECG - Pilot Study with Exploratory Data Analysis

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Trial Acronym

Carrera (CARdiac REspiratory RAdar)

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URL of the Trial

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Brief Summary in Lay Language

Sleep apnea relates to a disruption of respiratory activity during sleep. Patients affected often complain about non-restorative sleep. At the same time, sleep apna represents a persistent stress condition for the cardiovascular system which can gradually lead into severe cardiovascular morbidity if untreated. Most forms of sleep apnea are well treatable. However, they typically are diagnosed very late. Our study intends to contribute to earlier identification of patients. To this end, we will investigate, how often we find respiratory abnormalities during sleep in patients scheduled for routine Holter electrocardiography. In particular, we are interested how well we can identify, quantify and characterize sleep apnea by looking only at the ECG data. Patients included into our study will receive an additional small device monitoring their respiratiory activity during sleep.

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Brief Summary in Scientific Language

Sleep-related breathing disorders (SRBD) represent a fairly prevalent health concern. Persons affected are at higher risk for accidents in road traffic, at the workplace or at housework. Moreover, SRBD are associated with severe social and cardiovascular consequences and cause immense costs for the health care providers, and for the general public. In general, SRBD are well accessible to therapy. However, they typically are diagnosed very late. An earlier time of diagnosis and provision of adequate therapy could significantly increase patients’ quality and - in severe cases - expectance of life. At the same time, it would contribute to cost reduction.
A promising approach for earlier detection of SRDB consists in screening Holter-ECGs for SRBD. Different modulations in the ECG, which can be quantified by means of signal-analytic methods, permit to robustly identify respiratory activity during sleep. However, despite encouraging recognition rates, most existing studies dealing with ECG-based detection of SRBD suffer from significant limitations. This holds in particular with respect to the structure of the underlying patient sample, and with respect to ECG signal quality, which both deviate strongly from what is typically expected under routine Holter-ECG conditions. Consequently, such studies only have limited predictive power with respect to judging the adequacy and performance of screening Holter-ECGs for SRBD in clinical routine.
Against this background, our pilot study aims to collect a sample of largely unselected routine Holter-ECGs in 200 consecutive patients. A simultaneous nocturnal polygraphic recording will serve as reference for the evaluation of respiratory events detected from the ECG. A further sub-goal of the study is to obtain an estimate of the prevalence of SRBD in a general routine Holter-ECG collective, and – if possible – in several subgroups of interest. The main intention of the study is to conduct an exploratory analysis of the collected data with respect to the question, to which extent signal analysis of the routine Holter ECG permits the recognition of moderate to severe SRDB (i.e. SRBD requiring treatment).
Of particular interest are the questions, which ECG signal parameters are indicative of SRBD, which role does ECG signal quality play, and which other external factors and boundary conditions do affect recognizability. Explicitly, our study will include analysis of respiratory myogram interference in the ECG as a new approach which promises applicability even to patients with severe arrhythmias. Moreover, possibilities to differentiate between obstructive and central respiratory events will be evaluated.
It is hoped that the results of our study will contribute to a better understanding of the potential of adding a screening component for SRBD to routine analysis of the Holter-ECG, and to an improvement of recognition accuracy. According to the current state of knowledge, such an additional screening component could contribute to providing earlier targeted therapy to a significant proportion of so far undiagnosed patients suffering from SRBD.

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Organizational Data

  •   DRKS00008567
  •   2015/09/03
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  •   yes
  •   Approved
  •   S658-2013, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

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Health Condition or Problem studied

  •   G47.3 -  Sleep apnoea
  •   R06.3 -  Periodic breathing
  •   E66.2 -  Extreme obesity with alveolar hypoventilation
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Interventions/Observational Groups

  •   Patients who are scheduled for a Holter ECG recording owing to their medical history, will receive a polygraphy device upon inclusion to the study. It will be used to monitor nocturnal respiratory activity simultaneously to the Holter recording. Daytime sleepiness according to the Epworth Sleepiness Scalle will be assessed once. Moreover, data related to demography, known comorbidity and medication intake will be asked.
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Screening
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

The reference value for the severity of a sleep related breathing disorder will be the apnea-hypopnea index (AHI) as assessed from the polygraphy. An exploratory data analysis will identify the suitability of ECG parameters for robust detection of sleep apnea, and the level of sensitivity and specficity that can be expected from analysis of routine Holter ECG recordings. Moreover, the prevalence of sleep apnea in a routine Holter ECG collective will be estimated.

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Secondary Outcome

The possibility to specifically identify respiratory events of central origin from the routine Holter ECG, and the impact of concomitant factors like comorbidity or medication on the detectability of sleep related breathing disorders from the Holter ECG

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2014/10/30
  •   200
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Patients who are scheduled for a Holter ECG registration by the Heidelberg University Hospital. Patients must be able to attach polygraphy sensors and activate the pholygraphy device.

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Exclusion Criteria

none

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Addresses

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    • Medizinische Klinik (Krehl-Klinik), Abteilung Innere Medizin III (Kardiologie, Angiologie und Pneumologie)
    • Mr.  Dr.  Jörg  Friedrich 
    • Im Neuenheimer Feld 410
    • 69120  Heidelberg
    • Germany
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    • Hochschule Heilbronn, Fakultät für Informatik, Studiengänge Medizinische Informatik
    • Mr.  Dr.  Christoph  Maier 
    • Max-Planck-Str. 39
    • 74081  Heilbronn
    • Germany
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    • Medizinische Klinik (Krehl-Klinik), Abteilung Innere Medizin III (Kardiologie, Angiologie und Pneumologie)
    • Mr.  Dr.  Jörg  Friedrich 
    • Im Neuenheimer Feld 410
    • 69120  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • Medizinische Klinik, Abteilung Innere Medizin III (Kardiologie, Angiologie und Pneumoligie)
    • Mr.  Dr.  Jörg  Friedrich 
    • Im Neuenheimer Feld 410
    • 69120  Heidelberg
    • Germany
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    end of 1:1-Block address contact materialSupport
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    • Heinen + Löwenstein Gmbh&Co KG
    • Arzbacherstr. 80
    • 56130  Bad Ems
    • Germany
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    end of 1:1-Block address contact otherSupport
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    • Hochschule Heilbronn, Fakultät für Informatik, Studiengänge Medizinische Informatik
    • Mr.  Dr.  Christoph  Maier 
    • Max-Planck-Str. 39
    • 74081  Heilbronn
    • Germany
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    end of 1:1-Block address contact materialSupport
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    • Mortara Instrument Inc.
    • 7865 North 86th Street
    • WI 53224  Milwaukee
    • United States
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.