Clinical trial NCT00646477: ISIS 1 Therapeutic Effectiveness
Official title: Therapeutic Efficacy Evaluation of the CPAP/autoCPAP Sandman in the Treatment of New Patients With Obstructive Sleep Apnoea Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: OSAS (Obstructive Sleep Apneas Syndrome)
Lead sponsor: Tyco Healthcare Group
Sponsor class: INDUSTRY
First posted: 2008-03-28
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: May 2008
Secondary outcomes:
measure: To compare effective pressure Peff determined by the device and during manual titration
timeFrame: May 2008
measure: To compare the impact of the two-speed descent pressure algorithm
timeFrame: May 2008
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Hospital Michalon, sleep disorders center
Study officials:
affiliation: Tyco Healthcare Group
name: Veronique Grillier-Lanoir
role: STUDY_CHAIR
References: