Status:
COMPLETED
HYpopnea and Apnea Detection and Treatment Performance of a New cardiOreSpiratory Holter Monitor
Lead Sponsor:
LivaNova
Collaborating Sponsors:
University Hospital, Grenoble
Conditions:
Sleep Apnea, Obstructive
Eligibility:
All Genders
18+ years
Brief Summary
The HYPNOS study is an acute feasibility study to validate a new device for automatic detection and treatment of sleep apnea syndrome. The system is known as the PASITHEA system and it will perform th...
Eligibility Criteria
Inclusion
- above 18 years.
- Patient with diagnosed severe obstructive sleep apnea syndrome (AHI \> 30/h and \> 80% of obstructive events diagnosed on polysomnography or polygraphy performed less than 6 months ago )
- Patient free from CPAP treatment or any other SAS treatment for at least 3 months
- Patient with stable psychotropic medication since the diagnostic polysomnography or polygraphy exam
- Patient has signed the informed consent
Exclusion
- Patients sleeping less than 4 hours per night
- Patients suffering from respiratory failure or periodic breathing (cheynes stokes)
- Obese patient (BMI\>40kg/m2)
- Diabetic patient with autonomic dysfunction
- Vulnerable patient in accordance with article L1121-6 of CSP
- Patient with progressive malignant pathology
- Patient already involved in another clinical study that could affect the result of this study
- Pregnant patient
Key Trial Info
Start Date :
September 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 16 2015
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT03300037
Start Date
September 1 2014
End Date
April 16 2015
Last Update
October 3 2017
Active Locations (5)
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1
CHU Angers
Angers, France, 49000
2
Laboratoire du sommeil et d'EFCR; Hopital Michallon
Grenoble, France, 38043
3
CHU Montpellier
Montpellier, France
4
CHU Rennes
Rennes, France