Clinical trial NCT01889472: Impact of Interface With/Without Oral Appliance of Sleep Apnea Treatment
Official title: Impact of Nasal Mask/Oronasal Mask on Compliance to Treatment With Continuous Positive Airway Pressure (CPAP) in Patients With Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: CPAP compliance
leaks
Respiratory disturbances index
quality of life
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2013-06-28
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 treatment. The present investigation evaluates if CPAP compliance would increase when an oral appliance is used in combination with a nasal mask compared to the use of an oro-nasal mask. Eligible patients are those demonstrating a low compliance when using an oro-nasal mask during CPAP therapy. Patients will be treated with automatic CPAP with one of the above-detailed interfaces for 4 weeks and data will be extracted from the machine report in each condition.

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 Criteria:

* 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 Criteria:

* Clinical instability
* smoking cessation
* current weight loss strategy
* Marked anatomic abnormalities of upper airway (i.e. macroglossia, tonsils hypertrophy)
* severe cardio-metabolic co-morbidity

Primary outcomes:
measure: CPAP compliance
timeFrame: After 4 weeks of CPAP trial
Secondary outcomes:
measure: diurnal somnolence
timeFrame: After 4 weeks of CPAP trial
Other outcomes:
measure: Respiratory disturbances index
timeFrame: After 4 weeks of CPAP trial
Locations:
city: Montreal
country: Canada
facility: CHUM
state: Quebec
city: Quebec
country: Canada
facility: IUCPQ
city: Grenoble
country: France
facility: AGIRADOM
Study officials:
affiliation: Fondation IUCPQ
name: Frederic Series, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Borel JC, Tamisier R, Dias-Domingos S, Sapene M, Martin F, Stach B, Grillet Y, Muir JF, Levy P, Series F, Pepin JL; Scientific Council of The Sleep Registry of the French Federation of Pneumology (OSFP). Type of mask may impact on continuous positive airway pressure adherence in apneic patients. PLoS One. 2013 May 15;8(5):e64382. doi: 10.1371/journal.pone.0064382. Print 2013.
citation: Leotard A, Lesgoirres M, Daabek N, Lebret M, Bailly S, Verain A, Series F, Pepin JL, Borel JC. Adherence to CPAP with a nasal mask combined with mandibular advancement device versus an oronasal mask: a randomized crossover trial. Sleep Breath. 2019 Sep;23(3):885-888. doi: 10.1007/s11325-018-01772-5. Epub 2019 Jan 28.