Effect of Oxygen on Core Temperature

This study has been completed.
Sponsor:
Collaborator:
Swedish Heart Lung Foundation
Information provided by:
Umeå University
ClinicalTrials.gov Identifier:
NCT00543452
First received: October 12, 2007
Last updated: April 6, 2011
Last verified: March 2011
  Purpose

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


Condition Intervention
Cardiac Disease
Cheyne-Stokes Respiration
Other: Oxygen
Other: Air from a placebo oxygen delivery

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effect of Oxygen on Core Temperature

Resource links provided by NLM:


Further study details as provided by Umeå University:

Primary Outcome Measures:
  • Core temperature [ Time Frame: One day ] [ Designated as safety issue: No ]
    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 [ Time Frame: One day ] [ Designated as safety issue: No ]
    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


Enrollment: 40
Study Start Date: February 2005
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: oxygen
4 liters of oxygen a minute
Other: Oxygen
4 liters of oxygen a minute
Placebo Comparator: air
4 liters of room air
Other: Air from a placebo oxygen delivery
4 liters a minute of air from a placebo device

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Obstructive sleep apnea
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00543452

Locations
Sweden
Dept of respiratory medicine
Umeå, Sweden, SE 901 85
Sponsors and Collaborators
Umeå University
Swedish Heart Lung Foundation
Investigators
Principal Investigator: Karl A Franklin, MD, PhD Dept Respiratory Medicine, University Hospital, Umeå
  More Information

No publications provided

Responsible Party: Karl Franklin, Umeå University
ClinicalTrials.gov Identifier: NCT00543452     History of Changes
Other Study ID Numbers: 03-567
Study First Received: October 12, 2007
Last Updated: April 6, 2011
Health Authority: Sweden: Institutional Review Board

Additional relevant MeSH terms:
Cheyne-Stokes Respiration
Heart Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 16, 2014