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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 26, 2014