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ISIS 1 Therapeutic Effectiveness

NCT00646477 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2008-03-28

No results posted yet for this study

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

Conditions

  • OSAS (Obstructive Sleep Apneas Syndrome)

Interventions

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.

Sponsors & Collaborators

  • Tyco Healthcare Group

    lead INDUSTRY

Principal Investigators

  • Veronique Grillier-Lanoir · Tyco Healthcare Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2008-05-31
Completion
2008-05-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00646477 on ClinicalTrials.gov