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

NCT00811668 | Completed

• 1 other identifier: WI_VentCR_13/2008
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

Sleep Apnea Syndromes; heart diseases

Outcome Measures

Primary Outcomes (1)

• central apnea-hypopnea-index

  February 2009

Secondary Outcomes (1)

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

  February 2009

Study Arms (2)

CPAP before SOMNOVentCR

EXPERIMENTAL

started with CPAP and continued with SOMNOvent CR

Device: CPAP before SOMNOVentCR

SOMNOVentCR before CPAP

EXPERIMENTAL

began with SOMNOvent CR and ended with CPAP

Device: SOMNOventCR before CPAP

Interventions

CPAP before SOMNOVentCR DEVICE

4 weeks CPAP treatment, 1 week wash out period, 4 weeks SOMNOventCR treatment

CPAP before SOMNOVentCR

SOMNOventCR before CPAP DEVICE

4 weeks SOMNOventCR treatment, 1 week wash out period, 4 weeks CPAP treatment

SOMNOVentCR before CPAP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wissenschaftliches Institut Bethanien e.V: lead

Related Publications (5)

• 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.

  PMID: 16282177 BACKGROUND

• 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.

  PMID: 7812579 BACKGROUND

• 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.

  PMID: 11520725 BACKGROUND

• 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.

  PMID: 9372674 BACKGROUND

• 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: 9626176 BACKGROUND

MeSH Terms

Conditions

Heart Diseases; Sleep Apnea, Central; Sleep Apnea, Obstructive; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Wolfgang Galetke, PD Dr.

  STUDY CHAIR

• Winfried J. Randerath, Prof. Dr.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2008
• First Posted: December 19, 2008
• Study Start: May 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: October 1, 2009
• Last Updated: December 21, 2023

Record last verified: 2011-08