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The study is a prospective field evaluation to assess the therapeutic value of the CPAP/autoCPAP Sandman in 24 new diagnosed Obstructive Sleep Apneic patients.
Precisely, the study was designed to :
During the study, each patient underwent one night of full polysomnography with two consecutives therapeutic sequences during the same night, after randomization of the passage order:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Phase 1 : manual Phase 2 : automatic Descent rate pressure : slow |
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| B | Experimental | Phase 1 : manual Phase 2 : automatic Descent Rate Pressure : fast |
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| C | Experimental | Phase 1 : automatic Phase 2 : manual Descent rate pressure : slow |
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| D | Experimental | Phase 1 : automatic Phase 2 : manual Descent Rate Pressure : fast |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| titration night | Device | Each subject undergo 1 night of full polysomnography split into 2 consecutives and randomized sequences, using the Sandman device into two different modes: in APAP mode - Data analysis of this sequence will be used to evaluate the therapeutic effectiveness of the CPAP/autoCPAP Sandman in APAP mode compared both to the polysomnography registration and the diagnosis night for each enrolled patient. The type of respiratory events and their index/hour of sleep and the total arousal index will be appraised as markers of the efficacy of OSAS treatment, constituting the primary outcomes. in CPAP mode for manual titration sequence.During the manual titration, 5 constant pressure levels settings were studied for equal periods of 30 minutes gradually increasing the pressure. The aim of this sequence is to determine the sensitivity and the specificity of the CPAP/autoCPAP Sandman in detecting respiratory events. |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the sensitivity and specificity of the CPAP/autoCPAP Sandman in adequately detecting respiratory events and to evaluate the therapeutic effectiveness of the device in improving sleep quality and normalizing respiratory events | May 2008 |
| Measure | Description | Time Frame |
|---|---|---|
| To compare effective pressure Peff determined by the device and during manual titration | May 2008 | |
| To compare the impact of the two-speed descent pressure algorithm | May 2008 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Veronique Grillier-Lanoir | Tyco Healthcare Group | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Michalon, sleep disorders center | Recruiting | Grenoble | 38049 | France |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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|
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |