Treatment of Cheyne Stocks Respiration With Adaptive Servo Ventilation and Bilevel Ventilators in Patients With Chronic Heart Failure
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ClinicalTrials.gov Identifier: NCT00725595 |
Recruitment Status : Unknown
Verified August 2008 by Nanjing Medical University.
Recruitment status was: Recruiting
First Posted : July 30, 2008
Last Update Posted : August 26, 2008
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Condition or disease |
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Heart Failure Sleep Apnea |
Study Type : | Observational |
Estimated Enrollment : | 12 participants |
Observational Model: | Case-Only |
Study Start Date : | August 2008 |
Estimated Primary Completion Date : | December 2008 |
Estimated Study Completion Date : | December 2008 |

Group/Cohort |
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E, 2, III
To treat CSR with ASV and Bilevel ventilators
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- Both ASV and Bilevel ventilation are effective in clinical treatment of CSR [ Time Frame: three months ]
- 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 ]

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- 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
- Subject is > 18 years old
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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
- Expected to tolerate the ventilator therapy
Exclusion Criteria:
- Baseline oxygen saturation < 90% on a stable FIO2)
- Patient is currently enrolled in another clinical study which may confound the results of this study
- Patient for whom informed consent cannot be obtained
- Patient who is of pregnant or of child bearing potential without a negative pregnancy test within 10 days of the study procedure
- 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)
- Patients with severe COPD (per GOLD scale)
- Patients with a history of myocardial infarction within the 6 months prior to the study
- Patients with unstable angina

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): NCT00725595
Contact: Zhang Xilong, PhD | 96-25-83714511 ext 6723 | zhangxilong1952@yahoo.com.cn |
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 |
Responsible Party: | Glenn Richard, ResMed Inc. of Australia |
ClinicalTrials.gov Identifier: | NCT00725595 |
Other Study ID Numbers: |
092801 20070928 No 092801 |
First Posted: | July 30, 2008 Key Record Dates |
Last Update Posted: | August 26, 2008 |
Last Verified: | August 2008 |
Cheyne Stocks respiration heart failure sleep apnea ventilator |
Sleep Apnea Syndromes Heart Failure Heart Diseases Cardiovascular Diseases Apnea Respiration Disorders |
Respiratory Tract Diseases Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases |