Nocturnal Oxygen Treatment in Heart Failure and Cheyne-Stokes Respiration

NCT ID: NCT00338078

Last Updated: 2008-07-02

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

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-03-31

Study Completion Date

2006-12-31

Brief Summary

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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

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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.

Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Interventions

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nocturnal oxygen treatment from oxygen concentrators

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Umeå University

OTHER

Sponsor Role lead

Principal Investigators

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Karl A Franklin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Dept Respiratory Medicine, University Hospital, Umeå

Locations

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Dept of respiratory medicine

Umeå, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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241/98, dnr 98-165

Identifier Type: -

Identifier Source: org_study_id