ISIS 1 Therapeutic Effectiveness

Phase 3

• Conditions: OSAS (Obstructive Sleep Apneas Syndrome)
• Interventions: Device: titration night

• Registration Number: NCT00646477
• Lead Sponsor: Tyco Healthcare Group

Brief 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.

Study Timeline

• Study Start: 2007-10
• Status Verified: 2008-03
• Study First Submitted: 2008-03-25
• Study First Submitted QC: 2008-03-25
• Last Update Submitted: 2008-03-25
• Study First Posted: 2008-03-28
• Last Update Posted: 2008-03-28
• Primary Completion: 2008-05
• Study Completion: 2008-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• patient male or female, aged 18 to 75 years
• 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

• pneumothorax or pneumomediastin history
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A	titration night	Phase 1 : manual Phase 2 : automatic Descent rate pressure : slow
B	titration night	Phase 1 : manual Phase 2 : automatic Descent Rate Pressure : fast
C	titration night	Phase 1 : automatic Phase 2 : manual Descent rate pressure : slow
D	titration night	Phase 1 : automatic Phase 2 : manual Descent Rate Pressure : fast

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hospital Michalon, sleep disorders center; 🇫🇷 Grenoble, France