Nocturnal Oxygen Treatment in Heart Failure and Cheyne-St... | NCT00338078

Studies
Nocturnal Oxygen Treatment in Heart Failure and Cheyne-Stokes Respiration

NCT00338078

Sponsor

Umeå University

Status

Completed

Last Update Posted

Jul 2, 2008Estimated

Enrollment

62Actual

Phase

Not Applicable

Conditions

Heart Failure

Interventions

nocturnal oxygen treatment from oxygen concentrators

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1999

Primary Completion Date

Not provided

Completion Date

Dec 2006Actual

First Submitted Date

Jun 16, 2006

First Submission Date that Met QC Criteria

Jun 16, 2006

First Posted Date

Jun 20, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 1, 2008

Last Update Posted Date

Jul 2, 2008Estimated

Description Module

Brief Summary

The purpose of this study is to determine whether oxygen therapy during sleep improves quality of life, exercise capacity and heart function among patients with chronic heart failure and central sleep apnea.

Detailed Description

Oxygen therapy reduces the number of central apneas among patients with congestive heart failure but it is unknown whether quality of life and heart function also improve. We aim to test whether the quality of life, exercise capacity and heart function are improved with nocturnal oxygen therapy during 6 weeks with nocturnal oxygen from oxygen concentrator or nocturnal air from placebo concentrator.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

62Actual

Name	Type	Description	Arm Group Labels	Other Names
nocturnal oxygen treatment from oxygen concentrators	Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Exercise capacity
Quality of life (SF-36, Minnesota, Living with heart failure questionnaire)
Brain natriuretic peptide (BNP)

Secondary Outcomes

Measure	Description	Time Frame
Echocardiography
Radionuclide determination of ejection fraction
Mortality and hospitalization for cardiovascular causes (combined and individually)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Stable heart failure with left ventricular dysfunction
Cheyne-Stokes respiration with central AHI>15 and obstructive AHI<5

Exclusion Criteria:

Heart infarction within 3 months.
Dementia
Chronic obstructive pulmonary disease and daytime hypoxemia.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Karl A Franklin, MD, PhD	Dept Respiratory Medicine, University Hospital, Umeå	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept of respiratory medicine		Umeå		SE 901 85	Sweden

Condition Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided