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

NCT00725595 | Unknown DMC

• 3 other identifiers: 09280120070928No 092801
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Sleep Apnea

Keywords

Cheyne Stocks respiration; heart failure; sleep apnea; ventilator

Outcome Measures

Primary Outcomes (1)

• Both ASV and Bilevel ventilation are effective in clinical treatment of CSR

  three months

Secondary Outcomes (1)

• ASV treatment is more effective in removal or reduction of Cheyne-Stocks respiration than Bilevel ventilator for patients with chronic heart failure

  three months

Study Arms (1)

E, 2, III

To treat CSR with ASV and Bilevel ventilators

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with both CSR and heart failure

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nanjing Medical University: lead

Study Sites (1)

The 1st Affiliated Hospitak of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

RECRUITING

Related Publications (1)

• Zhang XL, Yin KS, Jiang SS, Li XL, Jia EZ, Su M. [Efficacy of adaptive pressure support servo-ventilation in patients with congestive heart failure and Cheyne-Stokes respiration]. Zhonghua Yi Xue Za Zhi. 2006 Jun 20;86(23):1620-3. Chinese.

  PMID: 16854301 RESULT

MeSH Terms

Conditions

Heart Failure; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Zhang Xilong, PhD

CONTACT

96-25-83714511; zhangxilong1952@yahoo.com.cn

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 28, 2008
• First Posted: July 30, 2008
• Study Start: August 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: August 26, 2008

Record last verified: 2008-08

Locations

CN (1)