NCT00646477

ISIS 1 Therapeutic Effectiveness

Therapeutic Efficacy Evaluation of the CPAP/autoCPAP Sandman in the Treatment of New Patients With Obstructive Sleep Apnoea Syndrome

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Tyco Healthcare Group · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• OSAS (Obstructive Sleep Apneas Syndrome)

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2007-10-01
• Primary completion: 2008-05-01
• Completion: 2008-05-01
• First posted: 2008-03-28
• Last updated: 2008-03-28

Locations

1 site across 1 country: France