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Comparison of CPAP With SOMNOventCR in Patients With Underlying Heart Disease, Combined OSA and CSR (VCR)

Primary Purpose

Heart Diseases, Sleep Apnea, Central, Sleep Apnea, Obstructive

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CPAP before SOMNOVentCR
SOMNOventCR before CPAP
Sponsored by
Wissenschaftliches Institut Bethanien e.V
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Diseases focused on measuring Sleep Apnea Syndromes, heart diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Men and women > 18 years.
  • Diagnosis of arterial hypertension or a coronary heart disease or a dilative cardiomyopathy
  • Combined sleep-apnea-syndrome with a total value of AHI>15 per hour and a rate up to 20% of central events or periodic breathing.

Exclusion Criteria:

  • Heart failure NYHA-CLASS IV.
  • Myocardial infarction or unstable angina pectoris or cardiac surgery within the last three months.
  • Apnea-hypopnea-index < 15 per hour.
  • Obstructive breathing disturbances up to 80%.
  • Pregnancy.
  • Absence of declaration of consent.
  • Malign diseases.
  • Serious (Severe) chronic oxygen-requiring pulmonary illness.
  • Age under 18 years.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    CPAP before SOMNOVentCR

    SOMNOVentCR before CPAP

    Arm Description

    started with CPAP and continued with SOMNOvent CR

    began with SOMNOvent CR and ended with CPAP

    Outcomes

    Primary Outcome Measures

    central apnea-hypopnea-index

    Secondary Outcome Measures

    Total apnea-hypopnea-index, minimum and mean oxygen saturation, compliance, subjective satisfaction with the therapy (questionnaire), left ventricular ejection fraction , six minutes walking distances.

    Full Information

    First Posted
    December 18, 2008
    Last Updated
    August 1, 2011
    Sponsor
    Wissenschaftliches Institut Bethanien e.V
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00811668
    Brief Title
    Comparison of CPAP With SOMNOventCR in Patients With Underlying Heart Disease, Combined OSA and CSR
    Acronym
    VCR
    Official Title
    Crossover Comparison of Treatment With Continuous Positive Airway Pressure and Treatment With Adaptive Servo Ventilation (SOMNOventCR) in Patients With Underlying Heart Disease, Combined Obstructive Sleep Apnea and Cheyne-Stokes Respiration.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2008 (undefined)
    Primary Completion Date
    February 2009 (Actual)
    Study Completion Date
    October 2009 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Wissenschaftliches Institut Bethanien e.V

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    In patients with underlying heart diseases like hypertensive heart disease, coronary heart disease or dilative cardiomyopathy obstructive sleep-apnea, central sleep-apnea and Cheyne-Stokes-respiration are common finding in polysomnography. In a lot of these patients it is neither a purely obstructive sleep-apnea syndrome nor a complete Cheyne-Stokes-respiration but a combination of both sleep related respiratory disturbances. Previous studies showed an improvement of the central respiratory disorder, for example Cheyne-Stokes-respiration, under continuous positive pressure breathing (CPAP) and an improvement of the left ventricular pump function. (Naughton 1995, Tkacova 1997). However, the recently published CanPAP study could not prove any improvement in the mortality among CPAP therapy patients in comparison to the optimal medical treatment, although under this therapy, the number of breathing disturbances, the oxygen saturation at night and the ejection fraction of the left ventricle showed a significant improvement.(Bradley 2005) Earlier studies proved the adaptive servo ventilation to be an effective therapy for patients with central sleep-apnea and Cheyne-Stokes-respiration respectively. (Teschler 2001) Teschler's study showed that the adaptive servo ventilation therapy with a reduction of central sleep apnea down to 10/hours succeeded. With the SOMNOvent CR a new therapy-algorithm has been developed for the adaptive servo ventilation in patients with obstructive sleep apnea and Cheyne-Stokes-respiration with underlying heart disease. In the first validation study this therapy was very effective and presented only few adverse effects in the patients. (Galetke 2007) The goal of the study was to compare this new therapeutic option (SOMNOvent CR) with the established method of continuous positive airway pressure (CPAP) in patients with combination of obstructive sleep-apnea syndrome and Cheyne-Stokes-respiration with underlying heart disease.
    Detailed Description
    Patients who meet all the above mentioned criteria and who were diagnosed as sleep-apnoea syndrome patients in our hospital were asked to participate in the study. We divided the patients in two groups: Group 1: started with CPAP and continued with SOMNOvent CR Group 2: began with SOMNOvent CR and ended with CPAP First of all a CPAP-titration was applied to both fixed groups during the second night. During the third night they received either the CPAP- pressure (first group) or the adaptive servo ventilation (second group. The patients were discharged from the hospital continuing with the procedure of the third night. After four weeks a new admission for the sleep laboratory was necessary and, during the first night, a control investigation with the procedure of the last four weeks. The procedure changed during the next night, so that the patients of the first group now slept with the SOMNOventCR-device and the patients of the second group with the CPAP-device. After a wash-out-period of a week and a four-week treatment with the last procedure a final in-hospital polysomnography was performed in which adaptive servo ventilation was applied to the first group and fixed CPAP to the second group. After the study ended, the patients received the therapy procedure which was the most effective and which was better tolerated. The following analyses were carried out in addition to the polysomnographic measurements: Admission 1: Berlin questionnaire, European sleep questionnaire, echocardiography, 6 minute walking test, patients questionnaire. Admission 2: ESS, Berlin questionnaire, echocardiography, 6 minute walking test, patients´ questionnaire. After the wash-out-period: ESS, Berlin questionnaire, patients questionnaire. Admission 4: ESS, Berlin questionnaire, echocardiography, 6 minute walking test, patients questionnaire.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heart Diseases, Sleep Apnea, Central, Sleep Apnea, Obstructive
    Keywords
    Sleep Apnea Syndromes, heart diseases

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    CPAP before SOMNOVentCR
    Arm Type
    Experimental
    Arm Description
    started with CPAP and continued with SOMNOvent CR
    Arm Title
    SOMNOVentCR before CPAP
    Arm Type
    Experimental
    Arm Description
    began with SOMNOvent CR and ended with CPAP
    Intervention Type
    Device
    Intervention Name(s)
    CPAP before SOMNOVentCR
    Intervention Description
    4 weeks CPAP treatment, 1 week wash out period, 4 weeks SOMNOventCR treatment
    Intervention Type
    Device
    Intervention Name(s)
    SOMNOventCR before CPAP
    Intervention Description
    4 weeks SOMNOventCR treatment, 1 week wash out period, 4 weeks CPAP treatment
    Primary Outcome Measure Information:
    Title
    central apnea-hypopnea-index
    Time Frame
    February 2009
    Secondary Outcome Measure Information:
    Title
    Total apnea-hypopnea-index, minimum and mean oxygen saturation, compliance, subjective satisfaction with the therapy (questionnaire), left ventricular ejection fraction , six minutes walking distances.
    Time Frame
    February 2009

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Men and women > 18 years. Diagnosis of arterial hypertension or a coronary heart disease or a dilative cardiomyopathy Combined sleep-apnea-syndrome with a total value of AHI>15 per hour and a rate up to 20% of central events or periodic breathing. Exclusion Criteria: Heart failure NYHA-CLASS IV. Myocardial infarction or unstable angina pectoris or cardiac surgery within the last three months. Apnea-hypopnea-index < 15 per hour. Obstructive breathing disturbances up to 80%. Pregnancy. Absence of declaration of consent. Malign diseases. Serious (Severe) chronic oxygen-requiring pulmonary illness. Age under 18 years.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Wolfgang Galetke, PD Dr.
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Winfried J. Randerath, Prof. Dr.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    16282177
    Citation
    Bradley TD, Logan AG, Kimoff RJ, Series F, Morrison D, Ferguson K, Belenkie I, Pfeifer M, Fleetham J, Hanly P, Smilovitch M, Tomlinson G, Floras JS; CANPAP Investigators. Continuous positive airway pressure for central sleep apnea and heart failure. N Engl J Med. 2005 Nov 10;353(19):2025-33. doi: 10.1056/NEJMoa051001.
    Results Reference
    background
    PubMed Identifier
    7812579
    Citation
    Naughton MT, Liu PP, Bernard DC, Goldstein RS, Bradley TD. Treatment of congestive heart failure and Cheyne-Stokes respiration during sleep by continuous positive airway pressure. Am J Respir Crit Care Med. 1995 Jan;151(1):92-7. doi: 10.1164/ajrccm.151.1.7812579.
    Results Reference
    background
    PubMed Identifier
    11520725
    Citation
    Teschler H, Dohring J, Wang YM, Berthon-Jones M. Adaptive pressure support servo-ventilation: a novel treatment for Cheyne-Stokes respiration in heart failure. Am J Respir Crit Care Med. 2001 Aug 15;164(4):614-9. doi: 10.1164/ajrccm.164.4.9908114.
    Results Reference
    background
    PubMed Identifier
    9372674
    Citation
    Tkacova R, Hall MJ, Liu PP, Fitzgerald FS, Bradley TD. Left ventricular volume in patients with heart failure and Cheyne-Stokes respiration during sleep. Am J Respir Crit Care Med. 1997 Nov;156(5):1549-55. doi: 10.1164/ajrccm.156.5.9612101.
    Results Reference
    background
    PubMed Identifier
    9626176
    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. doi: 10.1161/01.cir.97.21.2154.
    Results Reference
    background

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    Comparison of CPAP With SOMNOventCR in Patients With Underlying Heart Disease, Combined OSA and CSR

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