Trial of Auto Continuous Positive Airway Pressure (CPAP)
Reliability of Automatic CPAP Devices. A Double Blind Dummy Controlled Phase 1 Study
1 other identifier
interventional
1
1 country
1
Brief Summary
Background: In patients with obstructive sleep apnea, automatic continuous positive airway pressure machines (autoCPAP) are said to be capable of identifying various breathing abnormalities during sleep and to correct them by increasing progressively the positive pressure applied to the airway. Once breathing becomes normal, pressure slowly declines. AutoCPAP devices have never been tested in Phase I studies. The investigators hypothesised that normal breathing would not be recognised as such, and that pressure would increase even in a normal subject.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Aug 2009
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 4, 2010
CompletedFirst Posted
Study publicly available on registry
February 8, 2010
CompletedFebruary 16, 2010
February 1, 2010
2 months
February 4, 2010
February 15, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
number of episodes of increases in applied positive pressure, duration of each episode, and maximal pressure attained
one night
Secondary Outcomes (1)
reasons for pressure increase and consequences of the increase on sleep continuity
one night
Study Arms (2)
fixed CPAP
ACTIVE COMPARATORsubject will sleep with a fixed CPAP device at minimal pressure
autoCPAP
EXPERIMENTALthe subject will sleep connected to an autoCPAP device
Interventions
Eligibility Criteria
You may qualify if:
- normal subject
- male and female
- age 18 to 65 years old
You may not qualify if:
- obstructive sleep apnea
- unable to sleep with a CPAP device
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cliniques universitaires Saint-Luc
Brussels, 1200, Belgium
Related Publications (1)
Mwenge GB, Dury M, Delguste P, Rodenstein D. Response of automatic continuous positive airway pressure devices in a normal subject. Eur Respir J. 2011 Jun;37(6):1530-3. doi: 10.1183/09031936.00139510. No abstract available.
PMID: 21632834DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel Rodenstein, MD
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 4, 2010
First Posted
February 8, 2010
Study Start
August 1, 2009
Primary Completion
October 1, 2009
Study Completion
October 1, 2009
Last Updated
February 16, 2010
Record last verified: 2010-02