OSAS (Obstructive Sleep Apneas Syndrome) Clinical Trial
Official title:
Therapeutic Efficacy Evaluation of the CPAP/autoCPAP Sandman in the Treatment of New Patients With Obstructive Sleep Apnoea Syndrome
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 :
- 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
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:
- 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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment