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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00725595
Enrollment
12
Registered
2008-07-30
Start date
2008-08-31
Completion date
2008-12-31
Last updated
2008-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure, Sleep Apnea

Keywords

Cheyne Stocks respiration, heart failure, sleep apnea, ventilator

Brief summary

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.

Interventions

None listed

Sponsors

Nanjing Medical University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Both ASV and Bilevel ventilation are effective in clinical treatment of CSRthree months

Secondary

MeasureTime frame
ASV treatment is more effective in removal or reduction of Cheyne-Stocks respiration than Bilevel ventilator for patients with chronic heart failurethree months

Countries

China

Contacts

Primary ContactZhang Xilong, PhD
zhangxilong1952@yahoo.com.cn96-25-83714511

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026