Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fixed CPAP | Active Comparator | subject will sleep with a fixed CPAP device at minimal pressure |
|
| autoCPAP | Experimental | the subject will sleep connected to an autoCPAP device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPAP | Device | CPAP at 4 cm H2O |
| |
| autoCPAP |
| Measure | Description | Time Frame |
|---|---|---|
| number of episodes of increases in applied positive pressure, duration of each episode, and maximal pressure attained | one night |
| Measure | Description | Time Frame |
|---|---|---|
| reasons for pressure increase and consequences of the increase on sleep continuity | one night |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Daniel Rodenstein, MD | Cliniques universitaires Saint-Luc- Université Catholique de Louvain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cliniques universitaires Saint-Luc | Brussels | 1200 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21632834 | Derived | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Device |
autoCPAP working between 4 and 15 cm H2O |
|
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |