Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
24 participants
INTERVENTIONAL
2007-10-31
2008-05-31
Brief Summary
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Precisely, the study was designed to :
* evaluate the therapeutic efficacy of the CPAP/autoCPAP Sandman device in improving sleep quality and normalozing respiratory events
* determine the sensitivity and specificity of the device in adequately detecting respiratroy events
* compare effective pressure Peff determined by the device and during manual titration
* compare the impact of the two-speed descent pressure algorithm
Detailed Description
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* autotitrating pressure phase: sleep parameters and respiratory events vs results of the polysomnographic registration,
* manual titration phase: concordance between events respiratory analyzed on the polysomnographic recordings and the events detected by the CPAP / auto-CPAP.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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A
Phase 1 : manual Phase 2 : automatic Descent rate pressure : slow
titration night
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.
B
Phase 1 : manual Phase 2 : automatic Descent Rate Pressure : fast
titration night
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.
C
Phase 1 : automatic Phase 2 : manual Descent rate pressure : slow
titration night
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.
D
Phase 1 : automatic Phase 2 : manual Descent Rate Pressure : fast
titration night
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.
Interventions
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titration night
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.
Eligibility Criteria
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Inclusion Criteria
* weight \> 30kg
* patient with a newly diagnosed OSAS, under treatment with CPAP
* patient in stable condition
* patient affiliated to a social security insurance
* having given its written informed consent to participate to the study
Exclusion Criteria
* massive epistaxis (current or previous)
* decompensated heart failure or hypotension
* pneumoencephal history, recent trauma or surgery sequel with cranio-nasopharyngeal fistula
* acute sinusitis history, middle ear infection or perforation of the tympanic membrane
* respiratory insufficiency or severe respiratory illness with the possibility of residual hypoxemia
* severe bullous emphysema or previously complicated pneumothorax
* severe claustrophobia
18 Years
75 Years
ALL
No
Sponsors
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Tyco Healthcare Group
INDUSTRY
Responsible Party
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Tyco Healthcare Group
Principal Investigators
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Veronique Grillier-Lanoir
Role: STUDY_CHAIR
Tyco Healthcare Group
Locations
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Hospital Michalon, sleep disorders center
Grenoble, , France
Countries
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Facility Contacts
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Jean-Louis PEPIN, Pr
Role: primary
Other Identifiers
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ISIS 1
Identifier Type: -
Identifier Source: org_study_id