Outcome and Treatment of Complex Sleep Apnea
1 other identifier
interventional
N/A
1 country
1
Brief Summary
The purpose of the project is:
- 1.to determine the incidence of complex sleep apnea
- 2.to determine what percentage of cases will resolve over time with therapy with Continuous Positive Airway Pressure
- 3.Determine whether there is any difference in outcome, in those with persistent complex sleep apnea on CPAP, between those treated with CPAP or adaptive servo-ventilation.
Trial Health
Trial Health Score
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Started Jun 2011
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 1, 2010
CompletedFirst Posted
Study publicly available on registry
June 4, 2010
CompletedStudy Start
First participant enrolled
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedFebruary 13, 2015
October 1, 2010
2.3 years
June 1, 2010
February 11, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Resolution of sleep apnea
As measured by the apnea-hyponea index
24 weeks
Secondary Outcomes (1)
Quality of life
24 weeks
Study Arms (2)
CPAP
ACTIVE COMPARATORContinuous Positive Airway Pressure
Adaptive Servo-Ventilator
ACTIVE COMPARATORNon-invasive positive pressure ventilator that applies a constant expiratory pressure, as well as a variable inspiratory pressure.
Interventions
All patients will initially be treated with CPAP for 12 weeks as part of usual clinical treatment for sleep apnea. A sleep study will be conducted after this and prior to randomization into the study. If this repeat sleep study demonstrates persistent central sleep apnea, patients will be randomized into 2 study groups. Group 1 - CPAP for 24 weeks. Group 2 - first 12 weeks CPAP (Continuous Positive Airway Pressure. Next 12 weeks - (ASV) Adaptive Servo ventilation. If the treatment is not working well at 12 weeks the participant/patients have the option of switching to the alternate treatment. Patients will be notified if they are to be switched to ASV. Participants will be asked to fill in the Epworth Sleepiness Score Questionnaire and Sleep Apnea Quality of Life Index form at 12 and 24 weeks.
Eligibility Criteria
You may qualify if:
- Patient with obstructive sleep apnea who develop central sleep apnea once treated with CPAP
You may not qualify if:
- Inability to give informed consent, inability to tolerate positive pressure ventilation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Miseracordia Sleep Disorders Centre
Winnipeg, Manitoba, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 1, 2010
First Posted
June 4, 2010
Study Start
June 1, 2011
Primary Completion
September 1, 2013
Study Completion
September 1, 2013
Last Updated
February 13, 2015
Record last verified: 2010-10