Status:
UNKNOWN
ISIS 1 Therapeutic Effectiveness
Lead Sponsor:
Tyco Healthcare Group
Conditions:
OSAS (Obstructive Sleep Apneas Syndrome)
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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 : ...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2008
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00646477
Start Date
October 1 2007
End Date
May 1 2008
Last Update
March 28 2008
Active Locations (1)
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1
Hospital Michalon, sleep disorders center
Grenoble, France, 38049