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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01889472
Enrollment
15
Registered
2013-06-28
Start date
2013-06-30
Completion date
2017-01-18
Last updated
2017-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

Keywords

CPAP compliance, leaks, Respiratory disturbances index, quality of life

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.

Interventions

DEVICENasal mask and oral appliance vs oro-nasal mask during autoCPAP therapy

Sponsors

Laval University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
CPAP complianceAfter 4 weeks of CPAP trialCPAP compliance will be assessed according to machine report download for the 4 weeks of treatment in each study condition.

Secondary

MeasureTime frameDescription
diurnal somnolenceAfter 4 weeks of CPAP trialEpworth Sleepiness Score

Other

MeasureTime frameDescription
Respiratory disturbances indexAfter 4 weeks of CPAP trialProvided by CPAP report

Countries

Canada, France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026