Effect of Oxygen on Core Temperature

NCT ID: NCT00543452

Last Updated: 2011-04-07

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2010-09-30

Brief Summary

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Study of the effect of oxygen on the frequency of central apnea, sleep and body temperature in patients with a cardiac disease

Detailed Description

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Conditions

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Cardiac Disease Cheyne-Stokes Respiration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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oxygen

4 liters of oxygen a minute

Group Type ACTIVE_COMPARATOR

Oxygen

Intervention Type OTHER

4 liters of oxygen a minute

air

4 liters of room air

Group Type PLACEBO_COMPARATOR

Air from a placebo oxygen delivery

Intervention Type OTHER

4 liters a minute of air from a placebo device

Interventions

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Oxygen

4 liters of oxygen a minute

Intervention Type OTHER

Air from a placebo oxygen delivery

4 liters a minute of air from a placebo device

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Cardiac disease and Cheyne-Stokes respiration and controls without Cheyne-Stokes respiration

Exclusion Criteria

* Obstructive sleep apnea
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Swedish Heart Lung Foundation

OTHER

Sponsor Role collaborator

Umeå University

OTHER

Sponsor Role lead

Responsible Party

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Umeå University

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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03-567

Identifier Type: -

Identifier Source: org_study_id

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