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Effect of Oxygen on Core Temperature

Primary Purpose

Cardiac Disease, Cheyne-Stokes Respiration

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Oxygen
Air from a placebo oxygen delivery
Sponsored by
Umeå University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cardiac Disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Obstructive sleep apnea

Sites / Locations

  • Dept of respiratory medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

oxygen

air

Arm Description

4 liters of oxygen a minute

4 liters of room air

Outcomes

Primary Outcome Measures

Core temperature
This is an experitmetal study. Subjects receive oxygen or placebo-air during one night in random order. Outcome measure, i.e.core temperatue is measured continuously during this night with ongoing treatment of oxygen or placebo-air

Secondary Outcome Measures

Sleep stages, apnea-hypopnea index
This is an experitmetal study. Subjects receive oxygen or placebo-air during one night in random order. Outcome measure, i.e.the amount of differernt sleep stages, total sleep time and apnea-hypopnea index is measured during this night with ongoing treatment of oxygen or placebo-air

Full Information

First Posted
October 12, 2007
Last Updated
April 6, 2011
Sponsor
Umeå University
Collaborators
Swedish Heart Lung Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00543452
Brief Title
Effect of Oxygen on Core Temperature
Official Title
Effect of Oxygen on Core Temperature
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Umeå University
Collaborators
Swedish Heart Lung Foundation

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Disease, Cheyne-Stokes Respiration

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
oxygen
Arm Type
Active Comparator
Arm Description
4 liters of oxygen a minute
Arm Title
air
Arm Type
Placebo Comparator
Arm Description
4 liters of room air
Intervention Type
Other
Intervention Name(s)
Oxygen
Intervention Description
4 liters of oxygen a minute
Intervention Type
Other
Intervention Name(s)
Air from a placebo oxygen delivery
Intervention Description
4 liters a minute of air from a placebo device
Primary Outcome Measure Information:
Title
Core temperature
Description
This is an experitmetal study. Subjects receive oxygen or placebo-air during one night in random order. Outcome measure, i.e.core temperatue is measured continuously during this night with ongoing treatment of oxygen or placebo-air
Time Frame
One day
Secondary Outcome Measure Information:
Title
Sleep stages, apnea-hypopnea index
Description
This is an experitmetal study. Subjects receive oxygen or placebo-air during one night in random order. Outcome measure, i.e.the amount of differernt sleep stages, total sleep time and apnea-hypopnea index is measured during this night with ongoing treatment of oxygen or placebo-air
Time Frame
One day

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Cardiac disease and Cheyne-Stokes respiration and controls without Cheyne-Stokes respiration Exclusion Criteria: Obstructive sleep apnea
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karl A Franklin, MD, PhD
Organizational Affiliation
Dept Respiratory Medicine, University Hospital, Umeå
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept of respiratory medicine
City
Umeå
ZIP/Postal Code
SE 901 85
Country
Sweden

12. IPD Sharing Statement

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Effect of Oxygen on Core Temperature

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