NCT00543452

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

October 12, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 15, 2007

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

April 7, 2011

Status Verified

March 1, 2011

Enrollment Period

5.6 years

First QC Date

October 12, 2007

Last Update Submit

April 6, 2011

Conditions

Cardiac DiseaseCheyne-Stokes Respiration

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Sleep stages, apnea-hypopnea index

    One day

Study Arms (2)

oxygen

ACTIVE COMPARATOR

4 liters of oxygen a minute

Other: Oxygen

air

PLACEBO COMPARATOR

4 liters of room air

Other: Air from a placebo oxygen delivery

Interventions

OxygenOTHER

4 liters of oxygen a minute

oxygen
Air from a placebo oxygen deliveryOTHER

4 liters a minute of air from a placebo device

air

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Obstructive sleep apnea

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept of respiratory medicine

Umeå, SE 901 85, Sweden

Location

MeSH Terms

Conditions

Heart DiseasesCheyne-Stokes Respiration

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsGases

Study Officials

  • Karl A Franklin, MD, PhD

    Dept Respiratory Medicine, University Hospital, Umeå

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 12, 2007

First Posted

October 15, 2007

Study Start

February 1, 2005

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

April 7, 2011

Record last verified: 2011-03

Locations

SE(1)