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

NCT ID: NCT00725595

Last Updated: 2008-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-08-31

Study Completion Date

2008-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Heart Failure Sleep Apnea

Keywords

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Cheyne Stocks respiration heart failure sleep apnea ventilator

Study Design

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Observational Model Type

CASE_ONLY

Study Groups

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E, 2, III

To treat CSR with ASV and Bilevel ventilators

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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ResMed Inc. of Australia

Locations

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The 1st Affiliated Hospitak of Nanjing Medical University

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhang Xilong, PhD

Role: CONTACT

Phone: 96-25-83714511

Email: [email protected]

Facility Contacts

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Wang Hong, PhD

Role: primary

References

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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.

Reference Type RESULT
PMID: 16854301 (View on PubMed)

Other Identifiers

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20070928

Identifier Type: -

Identifier Source: secondary_id

No 092801

Identifier Type: -

Identifier Source: secondary_id

092801

Identifier Type: -

Identifier Source: org_study_id