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Treatment of Cheyne Stocks Respiration With Adaptive Servo Ventilation and Bilevel Ventilators in Patients With Chronic Heart Failure

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by Nanjing Medical University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT00725595
First received: July 28, 2008
Last updated: August 25, 2008
Last verified: August 2008
History of Changes
  Purpose

The overall purpose of this study is to determine the effects of adaptive servo ventilation (ASV) and bi-level ventilators on Cheyne-Stocks respiration (CSR). CSR is a pattern of breathing characterized by hyperpneas followed by hypopneas and or apneas. Clinically, the physiologic changes translate to sleep fragmentation, excessive daytime sleepiness, reduced exercise capacity and possibly ventricular arrhythmias. The intent of the proposed intervention is to compare the efficacies of ASV and Bi-level ventilator on CSR.


Condition Phase
Heart Failure
Sleep Apnea
 Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Nanjing Medical University:

Primary Outcome Measures:
  • Both ASV and Bilevel ventilation are effective in clinical treatment of CSR [ Time Frame: three months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ASV treatment is more effective in removal or reduction of Cheyne-Stocks respiration than Bilevel ventilator for patients with chronic heart failure [ Time Frame: three months ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: August 2008
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
E, 2, III
To treat CSR with ASV and Bilevel ventilators

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Patients with both CSR and heart failure

Criteria

Inclusion Criteria:

  1. Patient or legal representative of the patient is willing and able to sign an IRB/MEC approved informed consent and Privacy Protection Authorization in the United States
  2. Subject is > 18 years old

  3. Patients with known history of CSR. CSR symptoms may include the following:

    • sleep fragmentation as reported by patient or as witnessed by another person
    • night arousal after apneic episodes
    • reduced exercise capacity
    • daytime sleepiness
  4. Expected to tolerate the ventilator therapy

Exclusion Criteria:

  1. Baseline oxygen saturation < 90% on a stable FIO2)
  2. Patient is currently enrolled in another clinical study which may confound the results of this study
  3. Patient for whom informed consent cannot be obtained
  4. Patient who is of pregnant or of child bearing potential without a negative pregnancy test within 10 days of the study procedure
  5. Patients implanted with unable to tolerate inactive pacemaker, implantable defibrillator or cardiac resynchronization device for duration of testing procedure - approximately 8 hours (e.g. pacemaker dependency)
  6. Patients with severe COPD (per GOLD scale)
  7. Patients with a history of myocardial infarction within the 6 months prior to the study
  8. Patients with unstable angina
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00725595

Contacts
Contact: Zhang Xilong, PhD 96-25-83714511 ext 6723 zhangxilong1952@yahoo.com.cn

Locations
China, Jiangsu
The 1st Affiliated Hospitak of Nanjing Medical University Recruiting
Nanjing, Jiangsu, China, 210029
Contact: Wang Hong, PhD     86-83714511 ext 6705     zhsj_wh@hotmail.com    
Principal Investigator: Zhang Shijiang, MD            
Principal Investigator: Zhang Xilong, MD            
Sub-Investigator: Wang Hong, MD            
Sponsors and Collaborators
Nanjing Medical University
  More Information

Additional Information:
CSR and heart failure  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Glenn Richard, ResMed Inc. of Australia
ClinicalTrials.gov Identifier: NCT00725595     History of Changes
Other Study ID Numbers: 092801, 20070928, No 092801
Study First Received: July 28, 2008
Last Updated: August 25, 2008
Health Authority: China: Ethics Committee

Keywords provided by Nanjing Medical University:
Cheyne Stocks respiration
heart failure
sleep apnea
ventilator

Additional relevant MeSH terms:
Apnea
Heart Failure
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
 Heart Diseases
Cardiovascular Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on May 21, 2013