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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. The completion date has passed and the status has not been verified in more than two years.
Verified August 2008 by Nanjing Medical University.
Recruitment status was: Recruiting
Recruitment status was: Recruiting
Sponsor:
Nanjing Medical University
Information provided by:
Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT00725595
First received: July 28, 2008
Last updated: August 25, 2008
Last verified: August 2008
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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.
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only |
Resource links provided by NLM:
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 ]
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 ]
| 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 (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Study Population
Patients with both CSR and heart failure
Criteria
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
-
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00725595
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:
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 |
Keywords provided by Nanjing Medical University:
|
Cheyne Stocks respiration heart failure sleep apnea ventilator |
Additional relevant MeSH terms:
|
Heart Failure Sleep Apnea Syndromes Heart Diseases Cardiovascular Diseases Apnea Respiration Disorders |
Respiratory Tract Diseases Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases |
ClinicalTrials.gov processed this record on June 22, 2017