Trial of Auto Continuous Positive Airway Pressure (CPAP)
| Tracking Information | |||||
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| First Received Date ICMJE | February 4, 2010 | ||||
| Last Updated Date | February 15, 2010 | ||||
| Start Date ICMJE | August 2009 | ||||
| Primary Completion Date | October 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
number of episodes of increases in applied positive pressure, duration of each episode, and maximal pressure attained [ Time Frame: one night ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01064258 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
reasons for pressure increase and consequences of the increase on sleep continuity [ Time Frame: one night ] [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Trial of Auto Continuous Positive Airway Pressure (CPAP) | ||||
| Official Title ICMJE | Reliability of Automatic CPAP Devices. A Double Blind Dummy Controlled Phase 1 Study | ||||
| 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. |
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| Detailed Description | Material and Methods: We will submit one normal (confirmed with two polysomnographies, PSG) subject to a double blind study. Pairs of PSG will be performed on successive days once a week, one night with a 4 cm water fixed pressure CPAP device, previously shown not to disturb the subject's sleep and breathing, the other night with one of five well known autoCPAP devices programmed to work between 4 and 15 cm H2O pressure. The same mask and headgear will be used throughout the study. The subject and the physicians reading the tracings will ignore which device is being used on which night. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Obstructive Sleep Apnea | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | 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. No abstract available. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 1 | ||||
| Completion Date | October 2009 | ||||
| Primary Completion Date | October 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Belgium | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01064258 | ||||
| Other Study ID Numbers ICMJE | 2007/30MARS/67 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Daniel Rodenstein MD, Cliniques universitaires Saint-Luc | ||||
| Study Sponsor ICMJE | Cliniques universitaires Saint-Luc- Université Catholique de Louvain | ||||
| Collaborators ICMJE | Cliniques universitaires Saint-Luc | ||||
| Investigators ICMJE |
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| Information Provided By | Cliniques universitaires Saint-Luc- Université Catholique de Louvain | ||||
| Verification Date | February 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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