Status:
TERMINATED
Impact of Interface With/Without Oral Appliance of Sleep Apnea Treatment
Lead Sponsor:
Laval University
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
CPAP is the most effective treatment of obstructive sleep apnea. Oro-nasal masks may be used in case of mouth leaks but these are associated with higher positive pressure needs and lower compliance to...
Detailed Description
Participating subjects will be currently treated by CPAP and low compliance will be assessed according to machine report download demonstrating 3h or less of CPAP usage per night.
Eligibility Criteria
Inclusion
- normal nasal breathing
- dentition allowing for use of an oral appliance
- absence of mandibular joint pathology
- Patients requiring the use of a facial mask during CAPP titration due to presence of mouth leaks with a nasal/prong interface
- Patients using CPAP less than 3 hours/day as prescribed following CPAP titration
Exclusion
- Clinical instability
- smoking cessation
- current weight loss strategy
- Marked anatomic abnormalities of upper airway (i.e. macroglossia, tonsils hypertrophy)
- severe cardio-metabolic co-morbidity
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 18 2017
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01889472
Start Date
June 1 2013
End Date
January 18 2017
Last Update
May 5 2017
Active Locations (3)
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1
CHUM
Montreal, Quebec, Canada
2
IUCPQ
Québec, Canada, G1V 4G5
3
AGIRADOM
Grenoble, France