Status:
TERMINATED
Combination Therapy Associating CPAP and Mandibular Advancement Device in OSA
Lead Sponsor:
University Hospital, Grenoble
Collaborating Sponsors:
ONIRIS
Conditions:
Obstructive Sleep Apnea Syndrome
Hypertension
Eligibility:
All Genders
30-75 years
Phase:
NA
Brief Summary
The aim of this study is to evaluate the efficacy of a combination of Continuous Positive Airway Pressure (CPAP) and a Mandibular Advancement Device (MAD) on nocturnal Blood Pressure control in hypert...
Detailed Description
The aim of this study is to test the efficacy of a combination of Continuous Positive Airway Pressure (CPAP) treatment and a Mandibular Advancement Device (MAD) on the control of nocturnal Blood Press...
Eligibility Criteria
Inclusion
- Arterial Hypertension (Clinical Blood Pressure \> 140/90 mmHg or patient under medication with nocturnal hypertension seen in the Ambulatory Blood Pressure Measurement)
- Severe obstructive sleep apnea syndrome, treated by CPAP for more than 6 months and less than 5 years, with a compliance \<4h/night
- No contraindication to a treatment by Mandibular Advancement Device
- Ability to understand study procedures and signed informed consent
- Covered by French social security system or equivalent
Exclusion
- Central Obstructive Apnea (\>20% Central Apneas/Hypopneas)
- Pregnant or breastfeeding womens
- Prisoners or persons who require protection by the law
- Persons within the exclusion period of another study
- Contraindication to a mandibular advancement device (oral-dental pathology, pathology of the temporo-mandibular articulation, poor periodontal status)
Key Trial Info
Start Date :
November 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 18 2021
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04021810
Start Date
November 18 2019
End Date
May 18 2021
Last Update
May 26 2022
Active Locations (4)
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1
Nouvelle Clinique Bel Air
Bordeaux, France, 33073
2
University Hospital Grenoble
Grenoble, France, 38000
3
University Hospital Montpellier
Montpellier, France
4
Cabinet Médical
Perpignan, France, 66000