Effect of Oxygen on Core Temperature

Cardiac Disease Clinical Trial

Official title:

Effect of Oxygen on Core Temperature

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00543452
• Other study ID #: 03-567
• Status: Completed
• Phase: N/A
• First received: October 12, 2007
• Last updated: April 6, 2011
• Start date: February 2005
• Est. completion date: September 2010

Study information

• Verified date: March 2011
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Obstructive sleep apnea

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cardiac Disease
• Cheyne-Stokes Respiration
• Heart Diseases

Intervention

Other:
• Oxygen
4 liters of oxygen a minute
• Air from a placebo oxygen delivery
4 liters a minute of air from a placebo device

Locations

Country	Name	City	State
Sweden	Dept of respiratory medicine	Umeå

Sponsors (2)

Lead Sponsor	Collaborator
Umeå University	Swedish Heart Lung Foundation

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	One day	No
Secondary	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	One day	No