Impact of Interface With/Without Oral Appliance of Sleep Apnea Treatment

Obstructive Sleep Apnea Clinical Trial

Official title:

Impact of Nasal Mask/Oronasal Mask on Compliance to Treatment With Continuous Positive Airway Pressure (CPAP) in Patients With Obstructive Sleep Apnea

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01889472
• Other study ID #: MNB-003
• Secondary ID: JDBF-2012
• Status: Terminated
• Phase: N/A
• First received: June 19, 2013
• Last updated: May 3, 2017
• Start date: June 2013
• Est. completion date: January 18, 2017

Study information

• Verified date: May 2017
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: January 18, 2017
• Est. primary completion date: January 18, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• Nasal mask and oral appliance vs oro-nasal mask during autoCPAP therapy

Locations

Country	Name	City	State
Canada	CHUM	Montreal	Quebec
Canada	IUCPQ	Quebec
France	AGIRADOM	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
Laval University

Countries where clinical trial is conducted

Canada,  France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Respiratory disturbances index	Provided by CPAP report	After 4 weeks of CPAP trial
Primary	CPAP compliance	CPAP compliance will be assessed according to machine report download for the 4 weeks of treatment in each study condition.	After 4 weeks of CPAP trial
Secondary	diurnal somnolence	Epworth Sleepiness Score	After 4 weeks of CPAP trial